Eli Lilly and Co (LLY)

Lilly's Jaypirca (pirtobrutinib) recommended by CHMP for approval in the European Union for adults with chronic lymphocytic leukemia (CLL) across all lines of therapyJune 26, 2026 7:16 AM
PR Newswire (US) The positive opinion is based on results from the Phase 3 BRUIN CLL-313 and BRUIN CLL-314 trials, previously presented at the 2025 American Society of Hematology Annual Meeting and published in The Journal of Clinical OncologyBRUIN CLL-313 is the first Phase 3 study to evaluate a non-covalent BTK inhibitor exclusively in patients with treatment-naïve CLL and BRUIN CLL-314 is the first Phase 3 CLL trial to compare non-covalent and covalent BTK inhibitors, as well as the first to compare any BTK inhibitors in the treatment-naïve settingIf granted marketing authorization, this would expand pirtobrutinib's indication as a treatment option for patients with CLL in the European Union across all lines of therapyINDIANAPOLIS, June 26, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jaypirca (pirtobrutinib), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, for the treatment of adults with chronic lymphocytic leukemia (CLL) across all lines of therapy and regardless of prior BTK inhibitor treatment. Following this positive opinion, the application is now referred to the European Commission for final action. The European Commission's decision is expected in the next one to two months. "Results from BRUIN CLL-313 and BRUIN CLL-314 provide compelling evidence that pirtobrutinib can make a meaningful difference for people living with CLL across multiple lines of therapy," said Paolo Ghia, M.D., professor, medical oncology, Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milano, Italy. "The strong efficacy and tolerability demonstrated in these trials underscores the clinical value pirtobrutinib may offer patients. This positive opinion from the CHMP is an exciting and significant milestone, bringing us closer to a future where pirtobrutinib is an option for more people with CLL across the European Union."Results from BRUIN CLL-313 and BRUIN CLL-314 were presented at the American Society of Hematology (ASH) Annual Meeting and Exposition in December 2025 and published in The Journal of Clinical Oncology."Based on the strong results from the BRUIN CLL-313 and CLL-314 studies, we believe Jaypirca has the potential to serve as a meaningful new option for newly diagnosed patients and those who have not yet received a BTK inhibitor," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "Thanks to the impact of contemporary CLL treatments, many patients may receive fewer lines of therapy over their lifetime, making treatment choices in earlier lines profoundly important. This CHMP opinion represents a step toward an important global approval for Jaypirca in this indication and reflects our ambition to make Jaypirca available to every CLL patient who may benefit, at any line of therapy. Today, we are on the brink of making that a reality across the European Union as we await the European Commission's final decision."Lilly has also submitted these results to the U.S. Food and Drug Administration (FDA) for approval for adult patients with CLL, with a decision expected in the second half of 2026.About BRUIN CLL-313
BRUIN CLL-313 is a Phase 3, global, randomized, open-label study of pirtobrutinib versus chemoimmunotherapy (BR) in people with CLL/SLL without 17p deletions who have not been previously treated. The trial enrolled 282 patients who were randomized 1:1 to receive pirtobrutinib (200 mg orally, once daily) or BR per labeled doses. BR is a chemoimmunotherapy regimen used in the treatment of CLL. The primary endpoint is PFS as assessed by blinded IRC. Secondary endpoints include investigator and IRC assessed ORR, duration of response (DoR), and PFS, OS, time to next treatment (TTNT), safety and tolerability and patient-reported outcomes (PRO). About BRUIN CLL-314
BRUIN CLL-314 is a Phase 3, randomized, open-label study of Jaypirca (pirtobrutinib) versus Imbruvica (ibrutinib) in patients with CLL/SLL who were either treatment-naïve, or who were previously treated and were BTK inhibitor-naïve. The trial enrolled 662 patients who were randomized 1:1 to receive pirtobrutinib (200 mg orally, once daily) or ibrutinib (420 mg orally, once daily). The primary endpoint is ORR as assessed by blinded IRC. Secondary endpoints include investigator and IRC-assessed PFS, duration of response (DoR) and event-free survival (EFS), and time to next treatment (TTNT), OS, safety and tolerability, and patient-reported outcomes (PRO).About Jaypirca (pirtobrutinib)
Jaypirca (pirtobrutinib, formerly known as LOXO-305) (pronounced jay-pihr-kaa) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent inhibitor of the enzyme BTK.1 BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).2,3 Jaypirca is a U.S. FDA-approved oral prescription medicine, 100 mg or 50 mg tablets taken as a once-daily 200 mg dose with or without food until disease progression or unacceptable toxicity.About Chronic Lymphocytic Leukemia (CLL)
CLL is a form of slow-growing non-Hodgkin lymphoma that develops from white blood cells known as lymphocytes.4,5 CLL is one of the most common types of leukemia in adults.6  There are roughly 100,000 new cases of CLL globally each year, and the overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year.6,7  In CLL, the cancer cells are present in the blood.6INDICATIONS FOR JAYPIRCA (pirtobrutinib) (in the United States)Adult patients with relapsed or refractory?chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor.?Adult patients with relapsed or refractory?(R/R)?mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a?BTK inhibitor.?This?indication?is approved under accelerated approval based on response rate. Continued approval for this?indication?may be contingent upon verification and description of clinical?trial?benefit?in a confirmatory trial.IMPORTANT SAFETY INFORMATION FOR JAYPIRCA (pirtobrutinib)Infections: Fatal and serious infections (including bacterial, viral, fungal) and opportunistic infections occurred in Jaypirca-treated patients. Across clinical trials, Grade ≥3 infections occurred (25%), most commonly pneumonia (20%); fatal infections (5%), sepsis (6%), and febrile neutropenia (3.8%) occurred. In patients with CLL/SLL, Grade ≥3 infections occurred (32%), with fatal infections occurring in 8%. Opportunistic infections included Pneumocystis jirovecii pneumonia and fungal infection. Consider prophylaxis, including vaccinations and antimicrobial prophylaxis, in patients at increased risk for infection, including opportunistic infections. Monitor for signs and symptoms, evaluate, and treat. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.Hemorrhage: Fatal and serious hemorrhage has occurred with Jaypirca. Across clinical trials, major hemorrhage (Grade ≥3 bleeding or any central nervous system bleeding) occurred (2.6%), including gastrointestinal hemorrhage; fatal hemorrhage occurred (0.3%). Bleeding of any grade, excluding bruising and petechiae, occurred (16%). Major hemorrhage occurred when taking Jaypirca with (2.0%) and without (0.6%) antithrombotic agents. Consider risks/benefits of co-administering antithrombotic agents with Jaypirca. Monitor for signs of bleeding. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca. Consider withholding Jaypirca 3-7 days pre- and post-surgery based on surgery type and bleeding risk.Cytopenias: Jaypirca can cause cytopenias, including neutropenia, thrombocytopenia, and anemia. Across clinical trials, Grade 3 or 4 cytopenias, including decreased neutrophils (27%), decreased platelets (13%), and decreased hemoglobin (11%), developed. Grade 4 decreased neutrophils (15%) and Grade 4 decreased platelets (6%) developed. Monitor complete blood counts regularly. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.Cardiac Arrhythmias: Cardiac arrhythmias occurred in patients taking Jaypirca. Across clinical trials, atrial fibrillation or flutter were reported in 3.4% of Jaypirca treated patients, with Grade 3 or 4 atrial fibrillation or flutter in 1.6%. Other serious cardiac arrhythmias such as supraventricular tachycardia and cardiac arrest occurred (0.4%). Cardiac risk factors such as hypertension or previous arrhythmias may increase risk. Monitor and manage signs and symptoms of arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea). Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.Second Primary Malignancies: Across clinical trials, second primary malignancies, including non-skin carcinomas, developed in 9% of Jaypirca-treated patients, most frequently non-melanoma skin cancer (4.4%). Other second primary malignancies included solid tumors (including genitourinary and breast cancers) and melanoma. Advise patients to use sun protection and monitor for development of second primary malignancies.Hepatotoxicity, Including Drug-Induced Liver Injury (DILI): Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of DILI, has occurred in patients treated with BTK inhibitors, including Jaypirca. Evaluate bilirubin and transaminases at baseline and throughout Jaypirca treatment. For patients who develop abnormal liver tests after Jaypirca, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold Jaypirca. If DILI is confirmed, discontinue Jaypirca.Embryo-Fetal Toxicity: Jaypirca can cause fetal harm. Administration of pirtobrutinib to pregnant rats caused embryo-fetal toxicity, including embryo-fetal mortality and malformations at maternal exposures (AUC) approximately 3-times the recommended 200 mg/day dose. Advise pregnant women of fetal risk and females of reproductive potential to use effective contraception during treatment and for one week after last dose.Adverse Reactions (ARs) in Patients Who Received Jaypirca
The most common (≥30%) ARs in the pooled safety population of patients with hematologic malignancies (n=704) were decreased neutrophil count (54%), decreased hemoglobin (43%), decreased leukocytes (32%), fatigue (31%), decreased platelets (31%), decreased lymphocyte count (31%), calcium decreased (30%).Mantle Cell LymphomaSerious ARs occurred in 38% of patients, with pneumonia (14%), COVID-19 (4.7%), musculoskeletal pain (3.9%), hemorrhage (2.3%), pleural effusion (2.3%), and sepsis (2.3%) occurring in ≥2% of patients. Fatal ARs within 28 days of last dose occurred in 7% of patients, most commonly due to infections (4.7%), including COVID-19 (3.1% of all patients).Dose Modifications and Discontinuations Due to ARs: Dose reductions in 4.7%, treatment interruption in 32%, and permanent discontinuation of Jaypirca in 9% of patients. Permanent discontinuation in >1% of patients included pneumonia.Most common ARs (≥15%) and Select Laboratory Abnormalities (≥10%) (all Grades %; Grade 3-4 %): hemoglobin decreased (42; 9), platelet count decreased (39; 14), neutrophil count decreased (36; 16), lymphocyte count decreased (32; 15), creatinine increased (30; 1.6), fatigue (29; 1.6), musculoskeletal pain (27; 3.9), calcium decreased (19; 1.6), diarrhea (19; -), edema (18; 0.8), dyspnea (17; 2.3), AST increased (17; 1.6), pneumonia (16; 14), bruising (16; -), potassium decreased (13; 1.6), sodium decreased (13; -), lipase increased (12; 4.4), ALT increased (11; 1.6), potassium increased (11; 0.8), alkaline phosphatase increased (11; -). Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (10), platelets decreased (7), lymphocytes decreased (6).Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma from Single-Arm and Randomized Controlled Clinical Trials Serious ARs occurred in 47-56% of patients across clinical trials. Serious ARs in ≥5% of patients in the single-arm trial were pneumonia (18%), COVID-19 (9%), sepsis (7%), febrile neutropenia (7%). Serious ARs in ≥3% of patients in the randomized controlled trial were pneumonia (21%), COVID-19 (5%), sepsis (3.4%). Fatal ARs within 28-30 days of last Jaypirca dose occurred in 8-11% of patients, most commonly due to infections (7-10%), including sepsis (5%), COVID-19 (2.7-5%), and pneumonia (3.4%).Dose Modifications and Discontinuations Due to ARs: Dose reductions in 3.6-10%, treatment interruption in 42-51%, and permanent discontinuation of Jaypirca in 9-17% of patients. Permanent discontinuation in >1% of patients included second primary malignancy, pneumonia, COVID-19, neutropenia, sepsis, anemia, and cardiac arrythmias.Most common ARs and Select Laboratory Abnormalities (≥20%) (all Grades %, Grade 3-4 %)--in a randomized controlled trial: neutrophil count decreased (54; 26), hemoglobin decreased (45; 10), platelet count decreased (37; 17), pneumonia (28; 16), ALT increased (25; 1.8), creatinine increased (25; -), calcium decreased (23; 0.9), sodium decreased (22; 0.9), bilirubin increased (21; 0.9), upper respiratory tract infections (21; 0.9); in a single-arm trial: neutrophil count decreased (63; 45), hemoglobin decreased (48; 19), calcium decreased (40; 2.8), fatigue (36; 2.7), bruising (36; -), cough (33; -), musculoskeletal pain (32; 0.9), platelet count decreased (30; 15), sodium decreased (30; -), COVID-19 (28; 7), pneumonia (27; 16), diarrhea (26; -), abdominal pain (25; 2.7), lymphocyte count decreased (23; 8), ALT increased (23; 2.8), AST increased (23; 1.9), creatinine increased (23; -), dyspnea (22; 2.7), hemorrhage (22; 2.7), lipase increased (21; 7), alkaline phosphatase increased (21; -), edema (21; -), nausea (21; -), pyrexia (20; 2.7), headache (20; 0.9). Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (23).Drug InteractionsStrong CYP3A Inhibitors: Concomitant use increased pirtobrutinib systemic exposure, which may increase risk of Jaypirca ARs. Avoid using strong CYP3A inhibitors with Jaypirca. If concomitant use is unavoidable, reduce Jaypirca dose according to approved labeling.Strong or Moderate CYP3A Inducers: Concomitant use decreased pirtobrutinib systemic exposure, which may reduce Jaypirca efficacy. Avoid using Jaypirca with strong or moderate CYP3A inducers. If concomitant use with moderate CYP3A inducers is unavoidable, increase Jaypirca dose according to approved labeling.Sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP Substrates: Use with Jaypirca increased their plasma concentrations, which may increase risk of ARs related to these substrates for drugs sensitive to minimal concentration changes. Follow recommendations for these sensitive substrates in their approved labeling.Use in Specific PopulationsPregnancy and Lactation: Due to potential for Jaypirca to cause fetal harm, verify pregnancy status in females of reproductive potential prior to starting Jaypirca. Presence of pirtobrutinib in human milk is unknown. Advise women to use effective contraception and to not breastfeed while taking Jaypirca and for one week after last dose.Geriatric Use: In the pooled safety population of patients with hematologic malignancies, patients aged ≥65 years experienced higher rates of Grade ≥3 ARs and serious ARs compared to patients

Lilly launches "The Memory Radio Station" across Europe, inviting the public to visually reconstruct fading memories through GenAIJune 26, 2026 4:23 AM
PR Newswire (US) New multi-country campaign launches in Geneva alongside the European Academy of Neurology CongressGENEVA, June 26, 2026 /PRNewswire/ -- Today, Eli Lilly and Company (NYSE: LLY) launches The Memory Radio Station, a travelling public radio station and exhibition dedicated to the memories that makes us who we are – and to raise awareness of the early symptoms of Alzheimer's disease and the importance of acting on even the smallest changes.Launching at Palexpo in Geneva, alongside the European Academy of Neurology (EAN) Congress, The Memory Radio Station will travel to cities across multiple European countries including Austria, Germany, Italy and Belgium.The Memory Radio Station carries an urgent message: every memory is a reason to act. Memories connect us to the people and moments that define us, but memory is fragile – and that fragility is precisely what calls us to act. Traveling from city to city, the campaign invites the public to share personal memories, dedicate songs tied to meaningful moments, and take part in guided sessions that use generative AI to give visual form to memories that were never photographed or have begun to fade.The campaign launches at a critical moment for brain health in Europe, where disorders of the nervous system are now recognized as the leading cause of disability across the continent.1 Alzheimer's disease – the most common cause of dementia – can rob people of their memories, independence, relationships and ultimately their futures. It affected an estimated 9.5 million people in Europe in 2021, a figure projected to rise to 17.5 million by 2050.2 Despite its growing prevalence, Alzheimer's disease remains heavily underdiagnosed, with early symptoms often dismissed as part of normal aging.Inside The Memory Radio Station*
At the center of the experience is Synthetic Memories, a project at the intersection of community, arts and technology. Grounded in reminiscence therapy, it uses generative AI to give visual form to personal memories, including those that were never photographed or have begun to fade, helping people reconnect with the moments that shape their identity.3 In the Memory Radio Booth, visitors take part in sessions to share their stories. These stories are then transformed into prompts that generate images, which participants review and approve before being added to a living archive that continues to grow as the campaign travels across the continent.At the booth, visitors can explore interactive installations focused on brain health and access educational materials.Stéphane Epelbaum, Vice President, Medical IBU Neuroscience at Lilly, said: "Memory is deeply personal, but Alzheimer's disease is a shared challenge that touches millions of families across Europe. With The Memory Radio Station campaign, we want to meet people where they are – in public squares, in conversation, in the songs and stories that shape their lives. Our hope is that by discussing memory openly, we encourage more people to take early changes seriously. Noticing and acting early can make a meaningful difference for individuals and the people who love them."Paul Boon, Brain Health Mission Co-Chair at EAN, said: "Brain health starts with awareness. By encouraging people to reflect on their memories and engage with them in new ways, we can foster a deeper understanding of how to protect cognitive wellbeing throughout life. Starting a conversation about memories is an opportunity to promote healthier brains for the future."Airí Dordas, lead researcher at Domestic Data Streamers, said: "Memories are fragile and connected to deeply personal experiences. They are everyday moments that remain central to our identities and sense of belonging. The Memory Radio Station brings conversations about our memories into public spaces through a new form of memory storytelling using generative AI to visualize them. That is what makes this campaign meaningful to us: memory as a collective conversation, because every memory is a reason for connection. By bringing those stories into public spaces, we hope to create new ways for people to reflect on memory, brain health and what it means to preserve the moments that shape us."The Memory Radio Station campaign has been developed through a partnership between Lilly and Domestic Data Streamers (DDS), combining expertise and scientific research in Alzheimer's disease, storytelling and immersive technology. The campaign reflects Lilly's ongoing commitment to advancing understanding of Alzheimer's disease and encouraging earlier conversations around memory changes and brain health.*The experience is not a medical or therapeutic intervention and is not intended to diagnose, treat or assess any condition. All personal information is handled in accordance with applicable data protection laws, including the GDPR, and is not used for clinical research, commercial profiling or product promotion.About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. C-LLYAbout Domestic Data Streamers (DDS)
Domestic Data Streamers is a Barcelona-based collective whose Synthetic Memories project won the 2025 Ars Electronica Award for Digital Humanity, one of the world's most prestigious recognitions in media arts. DDS has worked in over 45 countries with cultural institutions including Tate Modern, the Barbican Center, and the California Academy of Sciences; organizations such as the United Nations, the World Food Programme and UNICEF; and brands including Spotify, Google and Cisco. DDS's research and work translate into films, installations, digital experiences, performances, or exhibitions in various contexts, such as schools, prisons, cinemas, museums, the streets of many cities, and the United Nations Headquarters. Learn more at www.domesticstreamers.com and https://www.syntheticmemories.net/Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.1 The Lancet Neurology. Europe at a brain health crossroads. The Lancet Neurology. 2026. Available at: https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(26)00132-8/fulltext 
2 Maresova P, Rezny L, Bauer P, et al. Nonpharmacological intervention therapies for dementia: potential break-even intervention price and savings for selected risk factors in the European healthcare system. BMC Public Health. 2024;24:1293.
3 Klein, SB, Nichols S. Memory and the sense of personal identify. Mind. 2012;121(483):677-702.Refer to: Emi Yasukawa; emi.yasukawa@lilly.com (Media)
Michael Czapar; czapar_michael_c@lilly.com (Investors)       View original content to download multimedia:https://www.prnewswire.co.uk/news-releases/lilly-launches-the-memory-radio-station-across-europe-inviting-the-public-to-visually-reconstruct-fading-memories-through-genai-302811677.html Original: Lilly launches "The Memory Radio Station" across Europe, inviting the public to visually reconstruct fading memories through GenAI

What Medicare Part D patients need to know about accessing Foundayo (orforglipron) and Zepbound (tirzepatide) for weight managementJune 25, 2026 6:45 AM
PR Newswire (US) A new Medicare pathway, the Medicare GLP-1 Bridge program, makes Lilly's obesity medicines – a daily pill or the number 1 most prescribed injectable – accessible to eligible Medicare Part D patients beginning July 1INDIANAPOLIS, June 25, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced additional details regarding the Medicare GLP-1 Bridge* program taking effect July 1, 2026. Under the program, Medicare Part D patients may be able to access Foundayo (orforglipron) or Zepbound (tirzepatide) KwikPen for single-patient-use for weight management. The Medicare GLP-1 Bridge program will be the first time eligible Medicare Part D patients will be able to broadly receive coverage for a GLP-1 for overweight or obesity.1 We believe this is a milestone that reflects growing recognition of the impact of obesity, including in older adults. Below is what patients and their healthcare providers need to know, including an overview of the clinical and program eligibility requirements determined by Centers for Medicare & Medicaid Services (CMS).Are Foundayo (orforglipron) and Zepbound (tirzepatide) covered by Medicare through the GLP-1 Bridge program?
Medicare Part D patients who meet the Medicare GLP-1 Bridge Clinical Criteria and other CMS eligibility requirements may be able to access Foundayo (orforglipron) or Zepbound (tirzepatide) for weight management under the Medicare GLP-1 Bridge program for $50 per month. Other weight management medications are also covered under the program. Coverage begins July 1, 2026, for new and existing patients and will run through December 31, 2027.Foundayo (orforglipron) and Zepbound (tirzepatide) are indicated for adults with obesity, or some adults with overweight who also have weight-related medical problems, along with a reduced calorie diet and increased physical activity.To learn more, visit www.lilly.com/lillydirect/medicare. For questions about the Medicare GLP-1 Bridge program, refer to https://www.medicare.gov/coverage/weight-loss-drugs.Why is this a milestone for people on Medicare living with obesity?
Until now, weight management medications have not been broadly covered by Medicare even though two in five U.S. adults aged 65 and older are living with obesity.2 Creating a Medicare Part D coverage pathway for eligible patients advances Lilly's long-held view of obesity as a chronic disease. It also unlocks access to Lilly's obesity medicines, offering patients and their doctors options rather than a one-size-fits-all approach."Lilly estimates that approximately 20 million Medicare patients may meet clinical criteria for obesity medicines, and starting July 1, eligible patients will be able to get Zepbound or Foundayo for $50 per month," said Ilya Yuffa, executive vice president and president of Lilly USA and Global Customer Capabilities. "For many, this will be the first time obesity treatment has been within reach. We're proud to offer Foundayo and Zepbound, giving patients and their doctors a real choice between a daily pill that requires no planning around food or drink and the number 1 most prescribed injectable for weight loss.3 Both are proven to deliver meaningful weight loss when paired with a reduced calorie diet and increased physical activity."How much do Foundayo (orforglipron) and Zepbound (tirzepatide) cost through the program?
Medicare Part D patients may be eligible for Foundayo or Zepbound for weight management for $50 a month, with a prior authorization and if they meet the Medicare GLP-1 Bridge Clinical Criteria and other CMS eligibility requirements. To learn more, visit www.lilly.com/lillydirect/medicare.What are Foundayo (orforglipron) and Zepbound (tirzepatide)?
Foundayo (orforglipron) and Zepbound (tirzepatide) are two different Lilly medicines for chronic weight management, giving patients and their healthcare providers a choice of treatment options. Foundayo is a once-daily oral pill that can be taken any time of day, with no planning around food or drink. Zepbound is the most prescribed injectable weight management medication in the U.S. Both are FDA-approved to help adults with obesity, or some adults with overweight who also have weight-related medical problems, lose excess body weight and keep it off, along with a reduced-calorie diet and increased physical activity.How do Foundayo (orforglipron) and Zepbound (tirzepatide) work in adults age 65 and older? 
In separate analyses of Phase 3 trials, both medicines were associated with meaningful weight loss in adults 65 and older, with safety profiles generally consistent with the overall study population. In a post-hoc analysis of ATTAIN-1, adults 65 and older without type 2 diabetes, experienced an average weight loss of 13% when taking the highest dose of Foundayo. In the ATTAIN program, Foundayo also led to reductions in many markers of cardiovascular risk, including waist circumference, non-HDL cholesterol, triglycerides and systolic blood pressure in adults of all ages.6In a separate 72-week Phase 3 study, SURMOUNT-1, 56.7% of adults of all ages without type 2 diabetes taking Zepbound (15 mg) achieved at least 20% body weight reduction.7 In a prespecified subgroup analysis of this study, adults 65 and older without type 2 diabetes lost an average of 14.1% of their body weight when taking the lowest approved maintenance dose of Zepbound (5 mg), which is only one step up from the starter dose.8"Obesity is a chronic, complex disease that deserves effective, long-term treatment options at every stage of life," said Rachel Batterham, senior vice president for Global Cardiometabolic Health at Lilly. "Data show Lilly's Foundayo and Zepbound were associated with meaningful weight loss in people aged 65 and older, with safety profiles generally consistent with other age groups, reinforcing that these medicines may be effective and appropriate for older adults."Who is eligible for these medicines through the Medicare GLP-1 Bridge program?
To qualify, a person must meet all of the Medicare GLP-1 Bridge Clinical Criteria and other CMS eligibility requirements when treatment is started:9Be 18 years of age or olderHave Medicare Part D drug coverage (not all plan types are covered)†Have a valid prescription, be using, or planning to use, Foundayo or Zepbound for weight management, alongside lifestyle modification consistent with the FDA approved labelsHave a Body Mass Index (BMI) of 35 or higher, or a BMI of 27 or higher with certain weight-related medical conditions (or have had one before starting a GLP-1 medicine)Patients currently receiving a GLP-1 through their Part D plan, those with type 2 diabetes, moderate-to-severe obstructive sleep apnea or fatty liver disease are not eligible (a Medicare Part D plan may already cover those conditions).Patients can talk with their healthcare providers about whether they qualify or refer to https://www.medicare.gov/coverage/weight-loss-drugs.How can eligible patients get started?
Starting July 1, 2026, eligible patients can begin in five steps:Talk with a healthcare provider about whether Foundayo or Zepbound is right for them.Request that the provider send a prescription to LillyDirect Pharmacy or a retail pharmacy of their choice.Work with the chosen pharmacy.Ensure that the provider completes a prior authorization.Once approved, the patient pays $50 per month for Foundayo or Zepbound. LillyDirect can help to determine eligibility and navigate the pre-authorization process. To learn more about eligibility, and see how to get started, visit www.lilly.com/lillydirect/medicare. For questions about Foundayo, Zepbound, or LillyDirect Pharmacy, call 1-844-559-3471.About Foundayo (orforglipron)
Foundayo (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day with no planning around food or drink. Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, orforglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.About Zepbound (tirzepatide) injection
Zepbound (tirzepatide) is the first and only dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist obesity medication. Zepbound tackles an underlying cause of excess weight. It reduces appetite and how much you eat. Zepbound is indicated for adults with obesity, or some adults who are overweight and also have at least one weight-related medical problem, to lose weight and keep it off. Additionally, Zepbound is FDA-approved to treat adults with moderate-to-severe obstructive sleep apnea and obesity. Zepbound should be used with a reduced calorie diet and increased physical activity.Warnings - Foundayo and Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.About ATTAIN-1 and ATTAIN-2 clinical trial program
The ATTAIN Phase 3 global clinical development program for Foundayo (orforglipron) has enrolled more than 4,500 people with obesity or overweight across two global registration trials.ATTAIN-1 (NCT05869903) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Foundayo 5.5 mg, 9 mg and 17.2 mg as a monotherapy to placebo in adults with obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease, who did not have diabetes. The trial is the first Phase 3 study of this patient population in which treatment was evaluated as an adjunct to exercise and a balanced, healthy diet rather than a reduced-calorie diet. The trial randomized 3,127 (195 were 65 and older) participants across the U.S., Brazil, China, India, Japan, South Korea, Puerto Rico, Slovakia, Spain and Taiwan in 3:3:3:4 ratio to receive either 5.5 mg, 9 mg or 17.2 mg Foundayo or placebo. The primary objective of the study was to demonstrate that Foundayo (5.5 mg, 9 mg or 17.2 mg) is superior to placebo in body weight reduction from baseline after 72 weeks in people with a BMI ≥30.0 kg/m² or a BMI ≥27.0 kg/m² with at least one weight-related comorbidity and a history of at least one self-reported unsuccessful dietary effort to lose body weight.ATTAIN-2 (NCT05872620) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Foundayo 5.5 mg, 9 mg or 17.2 mg as monotherapy with placebo in adults with obesity or overweight and type 2 diabetes. The trial randomized over 1,613 (418 were 65 and older) participants across the U.S., Argentina, Australia, Brazil, China, Czechia, Germany, Greece, India, South Korea and Puerto Rico in a 1:1:1:2 ratio to receive either 5.5 mg, 9 mg or 17.2 mg Foundayo or placebo. The primary objective of the study was to demonstrate that Foundayo (5.5 mg, 9 mg or 17.2 mg) is superior to placebo in mean body weight change from baseline at 72 weeks in people with a BMI ≥27.0 kg/m² and type 2 diabetes who are on stable treatment with either diet/exercise alone or up to three oral antihyperglycemic medications.In both trials, all participants in the Foundayo treatment arms started the study at a dose of Foundayo 0.8 mg once-daily and then increased the dose in a step-wise approach at four-week intervals to their final randomized maintenance dose of 5.5 mg (via steps at 0.8 mg and 2.5 mg), 9 mg (via steps at 0.8 mg, 2.5 mg and 5.5 mg) or 17.2 mg (via steps at 0.8 mg, 2.5 mg, 5.5 mg, 9 mg and 14.5 mg). These trials were conducted using an investigational formulation of Foundayo at dosages equivalent to Foundayo tablets.The post-hoc analysis included in this press release examined efficacy and safety outcomes in subgroups of participants aged

Lilly completes acquisition of Centessa Pharmaceuticals to advance treatments for sleep-wake disordersJune 24, 2026 8:45 AM
PR Newswire (US) INDIANAPOLIS, June 24, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the successful completion of its acquisition of Centessa Pharmaceuticals plc. Centessa is a clinical-stage company developing orexin receptor 2 agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders."The orexin system plays a fundamental role in human brain health, governing wakefulness, alertness, and the stability of sleep in ways that, when disrupted, can be profoundly disabling," said Carole Ho, Lilly executive vice president and president, Lilly Neuroscience. "For people living with narcolepsy, that disruption is severe and life-altering. Orexin's reach extends further to diseases impacted by disrupted sleep, and so does the unmet need. Centessa has built a clinical portfolio with the depth to explore both, and Lilly intends to pursue that potential with urgency."About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. F-LLYTrademarks and Trade Names 
All trademarks or trade names referred to in this press release are the property of Lilly, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the benefits of Lilly's acquisition of Centessa Pharmaceuticals, Lilly's neuroscience platform and development plans, Centessa's clinical-stage pipeline of programs targeting sleep disorders, including its lead program targeting orexin dysfunction, and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in implementing the acquisition and in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that Lilly will realize the expected benefits of the acquisition, that the acquisition will achieve the results discussed in this press release or that the acquisition will yield commercially successful products. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this press release.Refer to:Jessica Bardoulas; jessica.bardoulas@lilly.com (Media)
Michael Czapar; czapar_michael_c@lilly.com (Investors)   View original content to download multimedia:https://www.prnewswire.com/news-releases/lilly-completes-acquisition-of-centessa-pharmaceuticals-to-advance-treatments-for-sleep-wake-disorders-302808668.htmlSOURCE Eli Lilly and Company Original: Lilly completes acquisition of Centessa Pharmaceuticals to advance treatments for sleep-wake disorders

Lilly declares third-quarter 2026 dividendJune 22, 2026 11:00 AM
PR Newswire (US) INDIANAPOLIS, June 22, 2026 /PRNewswire/ -- The board of directors of Eli Lilly and Company (NYSE: LLY) has declared a dividend for the third quarter of 2026 of $1.73 per share on outstanding common stock.The dividend is payable on September 10, 2026, to shareholders of record at the close of business on August 14, 2026.About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. F-LLYCautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about expected dividend payments and reflects Lilly's current beliefs and expectations. However, there are significant risks and uncertainties in pharmaceutical research and development, as well as in business development activities and capital allocation strategies related to the company's business and actual results may differ materially due to various factors. For further discussion of risks and uncertainties relevant to Lilly's business that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.Refer to:Megan MacCauley; maccauley_megan@lilly.com (Media)
Michael Czapar; czapar_michael_c@lilly.com (Investors) View original content to download multimedia:https://www.prnewswire.com/news-releases/lilly-declares-third-quarter-2026-dividend-302806483.htmlSOURCE Eli Lilly and Company Original: Lilly declares third-quarter 2026 dividend

Lilly's Jaypirca (pirtobrutinib) significantly reduced the risk of disease progression or death by 45% when added to a venetoclax time-limited regimen in people with previously treated CLL/SLLJune 14, 2026 3:15 AM
PR Newswire (US) BRUIN CLL-322 is the first Phase 3 study to demonstrate superiority over a venetoclax-containing control arm in CLL, and, with the majority of patients previously treated with a covalent BTK inhibitor, reflects current practice patternsThese data will be highlighted in a late-breaking oral presentation at the 2026 European Hematology Association (EHA) Annual MeetingINDIANAPOLIS, June 14, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced results from the Phase 3 BRUIN CLL-322 clinical trial of Jaypirca (pirtobrutinib), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, plus venetoclax and rituximab versus venetoclax and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The study met its primary endpoint of independent review committee (IRC)-assessed progression-free survival (PFS), demonstrating that the addition of pirtobrutinib to a two-year venetoclax plus rituximab regimen reduced the risk of disease progression or death by 45% (HR=0.55 [95% CI, 0.40-0.75]; p=0.0001).These data will be highlighted in a late-breaking oral presentation at the 2026 European Hematology Association (EHA) Annual Meeting taking place in Stockholm, Sweden, as well as featured in the meeting's press program."These results from BRUIN CLL-322 show that the addition of pirtobrutinib as part of a time-limited regimen further enhanced an already effective treatment and extended the duration of remission for patients with previously treated CLL. Importantly, the study provides the first robust evidence for such an approach in patients who received a prior BTK inhibitor," said Matthew S. Davids, M.D., M.M.Sc., Chief of the Division of Lymphoma at Dana-Farber Cancer Institute, who is the lead author on the study. "Time-limited regimens are an important option in CLL care and provide patients with meaningful treatment-free intervals. In the context of the modern CLL treatment landscape, where many patients may only receive two lines of therapy, these results speak to the potential benefits that improving second-line therapy can have. Our study has the potential to establish a new standard of care in this population."BRUIN CLL-322 enrolled 639 relapsed or refractory patients, with 79.8% having prior covalent BTK inhibitor exposure, who were randomized 1:1 to receive pirtobrutinib plus venetoclax and rituximab (PVR, n=321) or venetoclax and rituximab alone (VR, n=318). Patients in the PVR arm received three cycles of pirtobrutinib and the first three cycles of rituximab before venetoclax was introduced. The efficacy results are based on a Feb. 2, 2026 data cutoff. At a median follow-up of 27.3 months, the primary endpoint of IRC-assessed PFS was significantly improved with the addition of pirtobrutinib to VR compared to VR alone (HR=0.55 [95% CI, 0.40-0.75]; p=0.0001). Median PFS in the PVR arm was not reached (95% CI, 43.3-NE), versus 39.7 months (95% CI, 35.9-NE) in the VR arm. The PFS results were consistent across prespecified subgroups, including patients with prior covalent BTK inhibitor exposure (PVR: not reached [95% CI, 41.5-NE] versus VR: 36.2 months [95% CI, 33.2-NE]), those who discontinued prior covalent BTK inhibitor due to progressive disease (PVR: 43.3 months [95% CI, 39.2-NE] versus VR: 33.2 months [95% CI, 28.3-37.5]), as well as those with high-risk features such as unmutated IGHV, TP53 mutation and/or 17p deletion, and/or complex karyotype. In an exploratory analysis of second-line patients whose disease progressed after a first-line covalent BTK inhibitor, the median PFS was not reached (95% CI, 30.1-NE) in the PVR arm and was 28.3 months (95% CI, 20.5-NE) in the VR arm (HR=0.32 [95% CI, 0.14-0.73]), with 24-month PFS rates of 88% (95% CI, 75.7-94.6) and 52% (95% CI, 34.7-66.2), respectively, and consistent benefit was observed regardless of the specific prior covalent BTK inhibitor received.Overall survival (OS), a key secondary endpoint, was not yet mature at this analysis (HR=0.89 [95% CI, 0.57-1.40]), and final testing of OS superiority is planned at a future date. An additional secondary endpoint, time to next treatment (TTNT), consistently favored the pirtobrutinib combination regimen (HR=0.50 [95% CI, 0.35-0.70]; nominal p

Zepbound (tirzepatide) and Shaquille O'Neal launch national campaign after NBA legend learns the obstructive sleep apnea he has lived with for years is treatableJune 10, 2026 9:30 AM
PR Newswire (US) In the national campaign Watch This, O'Neal gets real about living with moderate obstructive sleep apnea (OSA) and the moment he decided to do something about itZepbound® (tirzepatide) is the first and only prescription medicine for moderate-to-severe OSA in adults with obesity and should be used along with a reduced-calorie diet and increased physical activityINDIANAPOLIS, June 10, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that basketball legend and cultural icon Shaquille O'Neal is sharing his personal experience with moderate obstructive sleep apnea (OSA), including candid insight into his diagnosis and treatment journey with Zepbound® (tirzepatide). After years of dismissing fatigue, loud snoring and difficulty focusing as normal parts of his life, O'Neal learned they were actually symptoms of moderate-to-severe OSA. Moderate-to-severe OSA is a serious but often overlooked condition that affects approximately 24 million adults in the US, many with obesity. Most cases of moderate-to-severe OSA remain undiagnosed and untreated. Now, he's partnering with Lilly to raise awareness of the condition and encourage others to talk to their doctor. "For a long time, I was tired during the day, not sleeping well at night, and I just thought that's how it was for someone my size," said O'Neal. "When my doctor told me I had moderate obstructive sleep apnea, it clicked – this wasn't just about snoring, it was a real health condition. Being prescribed Zepbound helped make a difference for me in my OSA treatment journey; I even lost some weight. If sharing my story helps even one person talk to their doctor, that's a win."Moderate-to-severe OSA can be characterized by symptoms such as daytime fatigue, loud snoring, and difficulty concentrating, yet 85% of cases remain undiagnosed.To help close this awareness gap, Lilly is launching Watch This, a national, multi-channel campaign built around O'Neal's experience. The campaign spans broadcast, streaming, digital and social platforms, along with in-person community events and appearances. In his own voice, O'Neal shares the symptoms he dismissed for years and why he decided to take action, pointing audiences to resources at zepbound.lilly.com to recognize their own symptoms and connect with care and treatment options."Millions of people are living with moderate-to-severe OSA and may experience snoring, daytime sleepiness and irritability," said Lina Polimeni, senior vice president and chief marketing officer, consumer, at Lilly. "Shaquille was one of those people, so he didn't simply want to be another name on a campaign – he wanted to tell the truth about his own health on his own terms. That kind of honesty can help move other people from thinking they are just tired, experience chronic snoring, and have trouble sleeping, to recognizing they should talk to their doctor."Moderate-to-severe OSA in adults with obesity is treatable, and Lilly is committed to ensuring people have the resources they need to move from symptoms to diagnosis to care. People who believe they may be experiencing symptoms of OSA can visit Lilly.com to learn more about at-home testing or with their doctor to discuss treatment plans.Zepbound® is a prescription medicine for moderate-to-severe OSA in adults with obesity, which should be used along with a reduced-calorie diet and increased physical activity. In clinical studies along with diet and exercise, Zepbound® significantly reduced breathing interruptions during sleep, and some adults taking the medicine had no OSA symptoms after just one year. *†‡* In a 52-week study, adults taking Zepbound (10 mg or 15 mg) went from a starting average of 52.9 breathing disruptions per hour during sleep (as defined by AHI) to 27.6 (vs 50.1 events per hour to 44.8 with placebo). In another 52-week study of adults on positive airway pressure (PAP) therapy, those who took Zepbound (10 mg or 15 mg) went from a starting average of 46.1 breathing disruptions per hour during sleep to 16.8 (vs 53.1 events per hour to 47.6 with placebo). † In a 52-week study of adults, of those taking Zepbound (10 mg or 15 mg) with a starting average of 52.9 breathing disruptions per hour during sleep (as defined by AHI), 42.2% reached an AHI of

FDA approves Lilly's EBGLYSS® (lebrikizumab-lbkz) for one maintenance dose every eight weeks in patients with moderate-to-severe atopic dermatitisJune 9, 2026 6:18 PM
PR Newswire (US) EBGLYSS is now the only approved option that offers as few as six maintenance injections per year with no required topicals from the startINDIANAPOLIS, June 9, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) approved a regimen of one maintenance dose every eight weeks of a single injection (250 mg/2 mL) of EBGLYSS (lebrikizumab-lbkz) for subcutaneous use in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis. EBGLYSS is already approved for a once-monthly maintenance dose, with long-term data showing durable disease control. Now, EBGLYSS gives patients with moderate-to-severe atopic dermatitis the option to manage their condition with as few as six maintenance injections per year.1"Today's approval builds on EBGLYSS' established long-term durability, with a new option for one maintenance dose every eight weeks. For people living with moderate-to-severe atopic dermatitis, that means a treatment they only need to take as few as six times a year—without prescription topicals from the start," said Adrienne Brown, executive vice president and president of Lilly Immunology. "EBGLYSS now gives patients the opportunity to flare less and live their lives with fewer interruptions from atopic dermatitis."The approval is based on longitudinal exposure-response modeling data and supported by every-eight-week clinical data from an extension to the Phase 3 ADjoin long-term trial, which evaluated EBGLYSS maintenance dosing every four weeks or every eight weeks over 32 weeks.2"The option to extend EBGLYSS maintenance dosing to every eight weeks represents an important moment for patients living with moderate-to-severe atopic dermatitis," said Peter Lio, M.D., author of the ADjoin study and clinical assistant professor of dermatology and pediatrics, Northwestern University. "This new dosing regimen without mandatory topicals gives patients a new option to manage their condition based on individual needs. It's about meeting patients where they are in their lives."No new safety signals were noted in the EBGLYSS safety data in the 32-week ADjoin Q8W extension. No patients discontinued due to adverse events through 32 weeks. The most common (≥1%) adverse reactions reported with EBGLYSS are conjunctivitis, injection site reactions and herpes zoster.1"Living with moderate-to-severe atopic dermatitis often means dealing with a cycle of symptoms and time-intensive treatment routines during and in-between flares," said Kristin Belleson, president and CEO of the National Eczema Association. "Patients living with moderate-to-severe atopic dermatitis seek treatments that can offer durable disease control and fewer injections. This new option can ease the burden, allowing patients to spend less time thinking about managing their condition on a daily basis."Lilly has exclusive rights for development and commercialization of EBGLYSS in the U.S. and the rest of the world outside Europe. Almirall has licensed the rights to develop and commercialize EBGLYSS for the treatment of dermatology indications, including atopic dermatitis, in Europe.About the Q8W ADjoin Extension
The Q8W ADjoin extension (NCT04392154) evaluated EBGLYSS administered once every eight weeks (Q8W) and once every four weeks (Q4W), assessing its long-term safety and efficacy over 32 weeks in patients with moderate-to-severe atopic dermatitis across select countries. Adult and adolescent patients (ages 12–17, weighing ≥40 kg) who completed the 100-week ADjoin long-term study, including participants from the Phase 3 ADvocate 1 and 2 trials (52 weeks), ADore trial (52 weeks) and the ADopt-VA (16 weeks) trial, were eligible to enroll. Patients in this analysis received open-label EBGLYSS 250 mg, Q8W or Q4W, regardless of their previous treatment in ADjoin (Q2W or Q4W dose) or response at extension baseline. The approved maintenance dose of EBGLYSS is 250 mg every four weeks or 250 mg every eight weeks, after taking EBGLYSS 250 mg every two weeks for 16 weeks or later when adequate clinical response is achieved.About EBGLYSS
EBGLYSS is a monoclonal antibody that selectively targets and neutralizes IL-13 with high binding affinity and a slow dissociation rate.1,3,4 EBGLYSS binds to the IL-13 cytokine at an area that overlaps with the binding site of the IL-4Ra subunit of the IL-13Ra1/IL-4Ra heterodimer, preventing formation of this receptor complex and inhibiting IL-13 signaling. IL-13 is implicated as a primary cytokine tied to the pathophysiology of atopic dermatitis, driving the type-2 inflammatory loop in the skin, and EBGLYSS selectively targets IL-13.1The EBGLYSS Phase 3 program in atopic dermatitis consists of seven key global studies evaluating more than 1,600 patients, including two monotherapy studies (ADvocate 1 and 2), a combination study with topical corticosteroids (ADhere), long-term extension (ADjoin) and adolescent open-label (ADore) studies. The program also includes a study assessing the impact of EBGLYSS on vaccine immune response in adults (ADopt-VA). EBGLYSS has been studied in patients with skin of color (ADmirable) and in dupilumab-experienced patients (ADapt).EBGLYSS was approved in the U.S., Japan and Canada in 2024 and in the European Union in 2023. EBGLYSS is a first-line biologic treatment, administered with or without topical corticosteroids, that offers every-four-week or every-eight-week maintenance dosing for adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis that is not well-controlled with topical prescription therapies.1  In the U.S., the recommended initial starting dose of EBGLYSS is 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16 or later when adequate clinical response is achieved; after this, maintenance dosing is 250 mg every four weeks or every eight weeks.1Lilly is committed to serving patients living with moderate-to-severe atopic dermatitis and is working to enable broad first-line biologic access to EBGLYSS for patients not well-controlled with topical prescription therapy through commercial insurance. Lilly has coverage with all three major national pharmacy benefit managers and 94% of commercially insured patients have coverage through national health plans. We have expanded Medicaid coverage and are pursuing similarly broad Medicare coverage as part of Lilly's health equity and affordability initiative. Through Lilly Support Services™ for EBGLYSS®, Lilly offers a patient support program including co-pay assistance for eligible, commercially insured patients.INDICATION AND SAFETY SUMMARY  
EBGLYSS® (EHB-glihs) is an injectable medicine used to treat adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe eczema (atopic dermatitis) that is not well-controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. EBGLYSS can be used with or without topical corticosteroids.It is not known if EBGLYSS is safe and effective in children less than 12 years of age or in children 12 years to less than 18 years of age who weigh less than 88 pounds (40 kg).Warnings - Do not use EBGLYSS if you are allergic to lebrikizumab-lbkz or to any of the ingredients in EBGLYSS. See the Patient Information leaflet that comes with EBGLYSS for a complete list of ingredients.Before using
Before using EBGLYSS, tell your healthcare provider about all your medical conditions, including if you:Have a parasitic (helminth) infection.Are scheduled to receive any vaccinations. You should not receive a "live vaccine" if you are treated with EBGLYSS.Are pregnant or plan to become pregnant. It is not known if EBGLYSS will harm your unborn baby. If you become pregnant during treatment with EBGLYSS, you or your healthcare provider can call Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) to report the pregnancy.Are breastfeeding or plan to breastfeed. It is not known if EBGLYSS passes into your breast milk.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.Possible side effects
EBGLYSS can cause serious side effects, including:Allergic reactions. EBGLYSS can cause allergic reactions that may sometimes be severe. Stop using EBGLYSS and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms:breathing problems or wheezingswelling of the face, lips, mouth, tongue or throathivesitchingfainting, dizziness, feeling lightheadedskin rashcramps in your stomach area (abdomen)Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision.The most common side effects of EBGLYSS include:eye and eyelid inflammation, including redness, swelling, and itchinginjection site reactionsshingles (herpes zoster)These are not all of the possible side effects of EBGLYSS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.How to takeSee the detailed "Instructions for Use" that comes with EBGLYSS for information about how to prepare and inject EBGLYSS and how to properly store and throw away (dispose of) used EBGLYSS prefilled pens and prefilled syringes.Use EBGLYSS exactly as prescribed by your healthcare provider.EBGLYSS is given as an injection under the skin (subcutaneous injection).If your healthcare provider decides that you or a caregiver can give the injections of EBGLYSS, you or a caregiver should receive training on the right way to prepare and inject EBGLYSS. Do not try to inject EBGLYSS until you have been shown the right way by your healthcare provider. In children 12 years of age and older, EBGLYSS should be given by a caregiver.If you miss a dose of EBGLYSS, inject the missed dose as soon as possible, then inject your next dose at your regular scheduled time.Learn more
EBGLYSS is a prescription medicine available as a 250 mg/2 mL injection prefilled pen or prefilled syringe. For more information, call 1-800-545-5979 or go to ebglyss.lilly.com This summary provides basic information about EBGLYSS but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking to your doctor. Be sure to talk to your doctor or other healthcare provider about EBGLYSS and how to take it. Your doctor is the best person to help you decide if EBGLYSS is right for you.LK CON BS AD APPEBGLYSS®, its delivery device base, and Lilly Support Services™ are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLYTrademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, they are the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.Cautionary Statement Regarding Forward-Looking Statements  
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about EBGLYSS (lebrikizumab-lbkz) as a treatment for patients with moderate-to-severe atopic dermatitis and the timeline for future readouts, presentations, and other milestones relating to EBGLYSS and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that future study results will be consistent with the results to date or that EBGLYSS will receive additional regulatory approvals, or that it will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.1 EBGLYSS. Prescribing Information. Lilly USA, LLC.
2 Silverberg J, et al. Lebrikizumab every 8 weeks as maintenance dose provides long-lasting response in patients with moderate-to-severe atopic dermatitis. Presented at: Fall Clinical Dermatology Conference; 2025.
3 Okragly A, et al. Binding, neutralization and internalization of the interleukin-13 antibody, lebrikizumab. Dermatology and Therapy. Published online June 13, 2023. doi:10.1007/s13555-023-00947-7
4 Ultsch M, et al. Structural basis of signaling blockade by an interleukin-13 antibody lebrikizumab. Journal of Molecular Biology. 2013;425(8):1330-1339. doi:10.1016/j.jmb.2013.01.024CMAT-27572 06/2026 © Lilly USA, LLC 2026. All rights reserved.Refer to: Julia Brennan; julia.brennan@lilly.com (Lilly media)
Michael Czapar; czapar_michael_c@lilly.com (Investors)   View original content to download multimedia:https://www.prnewswire.com/news-releases/fda-approves-lillys-ebglyss-lebrikizumab-lbkz-for-one-maintenance-dose-every-eight-weeks-in-patients-with-moderate-to-severe-atopic-dermatitis-302795876.htmlSOURCE Eli Lilly and Company Original: FDA approves Lilly's EBGLYSS® (lebrikizumab-lbkz) for one maintenance dose every eight weeks in patients with moderate-to-severe atopic dermatitis

Lilly's oral GLP-1 Foundayo (orforglipron) delivered superior A1C control and weight loss in three pivotal type 2 diabetes trialsJune 8, 2026 2:30 PM
PR Newswire (US) In ACHIEVE-3, Foundayo 17.2 mg drove 57.1% greater relative reduction in A1C and 73.6% greater relative weight loss compared to oral semaglutide 14 mgIn ACHIEVE-2 and ACHIEVE-5, Foundayo delivered significant improvements in blood sugar and weight, with up to 68.6% and 69.1% of participants reaching an A1C goal of ≤6.5% respectivelyLilly plans to submit Foundayo for type 2 diabetes to the U.S. Food and Drug Administration by the end of the second quarterINDIANAPOLIS, June 8, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY), the maker of Zepbound (tirzepatide), today announced detailed results from three Phase 3 trials in the ACHIEVE program evaluating Foundayo (orforglipron), a small molecule oral GLP-1 taken without food or water restrictions, in adults with type 2 diabetes. In the landmark head-to-head ACHIEVE-3 trial, Foundayo outperformed oral semaglutide across the primary and all key secondary endpoints. In ACHIEVE-2 and ACHIEVE-5, Foundayo met the primary endpoint and key secondary endpoints, delivering superior A1C reduction and weight loss versus dapagliflozin and placebo added to insulin glargine respectively.1,2 Results from ACHIEVE-3, ACHIEVE-2 and ACHIEVE-5 were presented at the American Diabetes Association (ADA) 86th Scientific Sessions. ACHIEVE-3 was previously published in The Lancet, while ACHIEVE-2 and ACHIEVE-5 were published in The Lancet and JAMA, respectively."ACHIEVE-3 provides the first head-to-head data on oral GLP-1s in type 2 diabetes, with orforglipron showing greater A1C and weight reductions than oral semaglutide, which was tested at approved diabetes doses," said Dr. Julio Rosenstock, clinical professor of medicine at the University of Texas Southwestern Medical Center and ACHIEVE-3 lead investigator. "That level of efficacy is reinforced in ACHIEVE-2 and ACHIEVE-5, demonstrating a consistent and robust treatment effect across a wide spectrum of patient populations. These results support a potential shift toward using oral GLP-1 receptor agonist therapies like orforglipron earlier as a foundation of type 2 diabetes care."In ACHIEVE-3, Foundayo 9 mg and 17.2 mg outperformed oral semaglutide 7 mg and 14 mg in the first and only head-to-head Phase 3 trial of two oral GLP-1 receptor agonists for type 2 diabetes.3 Foundayo lowered A1C by an average of 1.9% (9 mg) and 2.2% (17.2 mg) compared to 1.1% (7 mg) and 1.4% (14 mg) with oral semaglutide at 52 weeks, a 57.1% greater relative reduction at the highest dose comparison. More patients taking the highest dose of Foundayo achieved an A1C

Eli Lilly shares climb after new obesity drug results impress at ADA conference (LLY)June 8, 2026 6:43 AM
IH Market News Eli Lilly and Company (NYSE:LLY) shares gained 4.5% after the pharmaceutical giant unveiled additional clinical data on its obesity treatment retatrutide during the American Diabetes Association (ADA) conference over the weekend. The company presented detailed findings from two Phase 3 studies, reinforcing investor confidence in the drug’s potential and highlighting the strength of Lilly’s expanding cardiometabolic portfolio. Retatrutide delivers strong weight-loss results At Saturday’s symposium, Eli Lilly shared full results from the TRANSCEND-T2D-1 and TRIUMPH-1 Phase 3 trials. TRANSCEND-T2D-1 examined retatrutide in treatment-naive patients with Type 2 diabetes, while TRIUMPH-1 focused on individuals with overweight or obesity who did not have Type 2 diabetes. Data from the TRIUMPH-1 study showed that patients receiving the 4mg dose of retatrutide achieved weight-loss outcomes that exceeded those reported in the STEP 1 trial of semaglutide. Notably, the results were within 4% of the weight reduction achieved with the highest 15mg dose of tirzepatide in the SURMOUNT 1 study, despite the lower retatrutide dose requiring only a single titration step. Safety profile remains in line with expectations According to analysts, the data met expectations for the drug candidate and did not reveal any new safety concerns. While key headline results from the first Phase 3 study had already been disclosed in late May, the weekend presentations provided a more comprehensive look at the findings. The accelerated timeline meant the data were not published simultaneously in a peer-reviewed scientific journal, but the additional detail appeared sufficient to reassure investors regarding the drug’s development trajectory. Lilly highlights broader obesity and metabolic pipeline During an investor event held on Saturday evening, Eli Lilly also provided updates on its wider cardiometabolic strategy. The company indicated that its long-acting amylin analogue, eloralintide, has the potential to become one of the largest Phase 3 development programmes in Lilly’s history. Investors are now awaiting combination trial data evaluating eloralintide alongside tirzepatide, which is expected later this year. Tirzepatide continues to gain ground on Novo Nordisk Lilly also highlighted the ongoing commercial success of tirzepatide, which is marketed as Mounjaro for Type 2 diabetes and Zepbound for obesity. The treatment has continued to capture market share from competing Novo Nordisk products Ozempic and Wegovy, both in the United States and, since the first quarter of 2026, in international markets as well. The latest clinical updates further strengthen Eli Lilly’s position in the rapidly expanding obesity and metabolic disease market, where competition among major pharmaceutical companies remains intense. Eli Lilly stock price Original: Eli Lilly shares climb after new obesity drug results impress at ADA conference (LLY)

Lilly's Foundayo (orforglipron), the only oral GLP-1 taken without food or water restrictions, was associated with significant weight loss in women at every stage of menopauseJune 7, 2026 11:00 AM
PR Newswire (US) In ATTAIN-1, women in perimenopause taking Foundayo lost up to 30.4 lbs (14.4%) and those in post-menopause lost up to 28.2 lbs (14.1%)In ATTAIN-2, women taking Foundayo lost significant weight across all stages of menopause, despite the additional challenge of living with type 2 diabetesAcross studies, women taking Foundayo saw meaningful reductions in their waist circumference, a measure associated with reduced abdominal fat and cardiometabolic riskINDIANAPOLIS, June 7, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY), the maker of Zepbound (tirzepatide), today announced results demonstrating that women with obesity or overweight who took the highest dose of Foundayo experienced significant weight loss at every stage of menopause. These findings, based on post-hoc analyses of more than 1,500 female participants in the ATTAIN-1 and ATTAIN-2 clinical trials, were presented at the American Diabetes Association (ADA) 86th Scientific Sessions.Menopause is a major, yet often overlooked, driver of weight gain. Hormonal changes during this time can accelerate fat accumulation, particularly around the abdomen, and make weight loss harder to achieve and sustain.1 Despite affecting tens of millions of women in the U.S. alone, menopausal status has rarely been evaluated as a factor in obesity treatment efficacy.2"Menopause can be an incredibly frustrating time for many women, partly because weight gain often feels beyond their control, and the biology of menopause can undermine even the most determined efforts to manage weight," said Rachel Batterham, OBE, MBBS, Ph.D., FRCP, Lilly senior vice president of medical innovation and external engagement. "These findings show that Foundayo was associated with meaningful weight loss in women at every stage of menopause. For women who have seen their weight become harder to manage precisely when their health is more at risk, this is what progress could look like."Across ATTAIN-1 and ATTAIN-2, Foundayo was associated with significant reductions in body weight at 72 weeks across menopausal stages. In ATTAIN-1, women who were pre-, peri- and post-menopausal lost up to 28.0 lbs (12.8%), 30.4 lbs (14.4%) and 28.2 lbs (14.1%) respectively on the highest dose of Foundayo. In ATTAIN-2, women with type 2 diabetes who were pre-, peri- and post-menopausal lost up to 23.4 lbs (11.3%), 18.5 lbs (8.9%) and 27.8 lbs (13.6%) respectively. At the highest dose, up to 51.5% of women in ATTAIN-1 and up to 44.2% in ATTAIN-2 experienced ≥15% weight loss. Women also experienced meaningful reductions in waist circumference, with decreases of up to 4.9 inches (12.5 cm) in ATTAIN-1 and up to 4.3 inches (11.0 cm) in ATTAIN-2 at 72 weeks.ATTAIN-1 and ATTAIN-2 Post-Hoc Analyses: Key Results with Foundayo 17.2 mgATTAIN-1
Pre-menopause(n=171)Perimenopause(n=142)Post-menopause(n=152)Baseline body weight219.1 lbs (99.4 kg)217.6 lbs (98.7 kg)208.6 lbs (94.6 kg)Change in body weight from baseline-12.8% (-28.0 lbs; -12.7 kg)-14.4% (-30.4 lbs; -13.8 kg)-14.1% (-28.2 lbs; -12.8 kg)Percent of participants achieving ≥5% weight loss80.3 %80.9 %82.7 %Percent of participants achieving ≥10% weight loss 61.5 %64.2 %64.1 %Percent of participants achieving ≥15% weight loss40.9 %51.5 %45.4 %Percent of participants achieving ≥20% weight loss24.2 %29.9 %23.8 %Change in waist circumference from baseline-4.5 in (-11.4 cm)-4.9 in (-12.5 cm)-4.8 in (-12.3 cm)ATTAIN-2
Pre-menopause(n=10)Perimenopause(n=33)Post-menopause(n=109)Baseline body weight237.9 lbs (107.9 kg)209.7 lbs (95.1 kg)202.2 lbs (91.7 kg)Change in body weight from baseline-11.3% (-23.4 lbs; -10.6 kg)-8.9% (-18.5 lbs; -8.4 kg)-13.6% (-27.8 lbs; -12.6 kg)Percent of participants achieving ≥5% weight loss79.5 %67.1 %81.6 %Percent of participants achieving ≥10% weight loss52.5 %39.5 %68.0 %Percent of participants achieving ≥15% weight loss36.4 %20.4 %44.2 %Percent of participants achieving ≥20% weight loss32.1 %9.7 %21.7 %Change in waist circumference from baseline-4.3 in (-11.0 cm)-3.3 in (-8.4 cm)-4.3 in (-11.0 cm)About Foundayo
Foundayo (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake. Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, orforglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.About ATTAIN-1, ATTAIN-2 and ATTAIN clinical trial program 
ATTAIN-1 (NCT05869903) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Foundayo 5.5 mg, 9 mg and 17.2 mg as a monotherapy to placebo in adults with obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease, who did not have diabetes. The trial is the first Phase 3 study of this patient population in which treatment was evaluated as an adjunct to exercise and a balanced, healthy diet rather than a reduced-calorie diet. The trial randomized 3,127 participants across the U.S., Brazil, China, India, Japan, South Korea, Puerto Rico, Slovakia, Spain and Taiwan in 3:3:3:4 ratio to receive either 5.5 mg, 9 mg or 17.2 mg Foundayo or placebo. The primary objective of the study was to demonstrate that Foundayo (5.5 mg, 9 mg or 17.2 mg) is superior to placebo in body weight reduction from baseline after 72 weeks in people with a BMI ≥30.0 kg/m² or a BMI ≥27.0 kg/m² with at least one weight-related comorbidity and a history of at least one self-reported unsuccessful dietary effort to lose body weight.ATTAIN-2 (NCT05872620) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Foundayo 5.5 mg, 9 mg or 17.2 mg as monotherapy with placebo in adults with obesity or overweight and type 2 diabetes. The trial randomized over 1,600 participants across the U.S., Argentina, Australia, Brazil, China, Czechia, Germany, Greece, India, South Korea and Puerto Rico in a 1:1:1:2 ratio to receive either 5.5 mg, 9 mg or 17.2 mg Foundayo or placebo. The primary objective of the study was to demonstrate that Foundayo (5.5 mg, 9 mg or 17.2 mg) is superior to placebo in mean body weight change from baseline at 72 weeks in people with a BMI ≥27.0 kg/m² and type 2 diabetes who are on stable treatment with either diet/exercise alone or up to three oral antihyperglycemic medications.In both trials, all participants in the Foundayo treatment arms started the study at a dose of Foundayo 0.8 mg once-daily and then increased the dose in a step-wise approach at four-week intervals to their final randomized maintenance dose of 5.5 mg (via steps at 0.8 mg and 2.5 mg), 9 mg (via steps at 0.8 mg, 2.5 mg and 5.5 mg) or 17.2 mg (via steps at 0.8 mg, 2.5 mg, 5.5 mg, 9 mg and 14.5 mg). These trials were conducted using an investigational formulation of Foundayo at dosages equivalent to Foundayo tablets.Endnotes and ReferencesKapoor E, Collazo-Clavell ML, Faubion SS. Weight gain in women at midlife: a concise review. J Clin Endocrinol Metab. 2017;102(10):3732-3741.North American Menopause Society. The 2023 position statement of The North American Menopause Society. Menopause. 2023;30(4):573-590.INDICATION AND SAFETY SUMMARY WITH WARNINGS
Foundayo (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.Foundayo should not be used with other GLP-1 receptor agonist medicines.It is not known if Foundayo is safe and effective for use in children.Warnings – Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo.Foundayo may cause serious side effects, including:Inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away.Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery.Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo.Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures.Common side effects
The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.Before taking FoundayoTell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works.Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo.Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.Review these questions with your healthcare provider:? Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
? Do you have a history of diabetic retinopathy?
? Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
? Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby.
? Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo.
? Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements?How to takeTake Foundayo exactly as your healthcare provider tells you to.Use Foundayo with a reduced-calorie diet and increased physical activity.Take Foundayo by mouth 1 time each day, with or without food.Swallow tablets whole. Do not break, crush, or chew the tablet.If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day.Do not take more than 1 tablet per day.If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment.If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.Learn more
Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com.This summary provides basic information about Foundayo but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you.OG CON BS APR2026ZEPBOUND INDICATIONS AND SAFETY SUMMARY WITH WARNINGSZepbound (ZEHP-bownd) is an injectable prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with:obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA.Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children.Warnings - Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound.KwikPen: Do not share your KwikPen with other people, even if the pen needle has been changed. You may give other people a serious infection or get a serious infection from them.Zepbound may cause serious side effects, including:Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away.Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. You may feel the pain from your abdomen to your back.Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery.Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound.Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures.Common side effectsThe most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch. Before using ZepboundYour healthcare provider should show you how to use Zepbound before you use it for the first time.Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound.Review these questions with your healthcare provider:? Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
? Do you take diabetes medicines, such as insulin or sulfonylureas?
? Do you have a history of diabetic retinopathy?
? Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
? Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
? Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound   may harm your unborn baby. Tell your healthcare provider if you become pregnant while using  Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound.Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Lilly at 1-800-LillyRx (1-800-545-5979).How to takeRead the Instructions for Use that come with Zepbound.Use Zepbound exactly as your healthcare provider says.Use Zepbound with a reduced-calorie diet and increased physical activity.Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen), thigh, or have another person inject in the back of the upper arm. Do not inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously).Use Zepbound 1 time each week, at any time of the day.Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.Zepbound is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg injection.Learn more
Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to www.zepbound.lilly.com.This summary provides basic information about Zepbound but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you.ZP CON BS 25FEB2026About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLYCautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Foundayo (orforglipron) as a potential treatment for adults with obesity and the timeline for future readouts, presentations, and other milestones relating to Foundayo and its clinical trials, and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that Foundayo will receive additional regulatory approvals, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.Refer to:     Niki Biro; niki_biro@lilly.com (Media)
Michael Czapar; czapar_michael_c@lilly.com (Investors) View original content to download multimedia:https://www.prnewswire.com/news-releases/lillys-foundayo-orforglipron-the-only-oral-glp-1-taken-without-food-or-water-restrictions-was-associated-with-significant-weight-loss-in-women-at-every-stage-of-menopause-302793332.htmlSOURCE Eli Lilly and Company Original: Lilly's Foundayo (orforglipron), the only oral GLP-1 taken without food or water restrictions, was associated with significant weight loss in women at every stage of menopause

Lilly's triple agonist, retatrutide, drove substantial improvements in weight, A1C, knee osteoarthritis pain, and obstructive sleep apnea, demonstrating its remarkable potential to treat obesity and its complicationsJune 6, 2026 2:30 PM
PR Newswire (US) In TRIUMPH-1, participants on retatrutide 12 mg lost an average of 70.3 lbs (28.3%) over 80 weeks, with 65.3% achieving a BMI below 30, no longer meeting the BMI criteria for obesityIn addition to weight loss, retatrutide reduced knee osteoarthritis pain by up to 4.3 points (73.1%) and moderate-to-severe obstructive sleep apnea severity by up to 36.1 events per hour (60.6%)In TRANSCEND-T2D-1, participants on retatrutide achieved A1C reductions of up to 2.0% and weight loss of up to 36.6 lbs (16.8%) at 40 weeks, with up to 46% achieving a normal A1CINDIANAPOLIS, June 6, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY), the maker of Zepbound (tirzepatide) and Foundayo (orforglipron), today announced additional positive results from pivotal Phase 3 trials of retatrutide, an investigational, first-in-class GIP, GLP-1, and glucagon triple hormone receptor agonist, showing substantial weight loss along with meaningful improvements across knee osteoarthritis pain, moderate-to-severe obstructive sleep apnea, and type 2 diabetes – common obesity-related conditions.1,2 The findings from TRIUMPH-1 and TRANSCEND-T2D-1 were presented at the American Diabetes Association (ADA) 86th Scientific Sessions, with TRANSCEND-T2D-1 results simultaneously published in The Lancet."Obesity drives more than 200 downstream diseases, yet we have historically treated those conditions one at a time and in silos," said Ania Jastreboff, M.D., Ph.D., Professor of Medicine & Pediatrics (Endocrinology) at the Yale School of Medicine, Director of the Yale Obesity Research Center (Y-Weight), and lead investigator. "In TRIUMPH-1 and TRANSCEND-T2D-1, treatment with retatrutide resulted in substantial weight reduction together with clinically meaningful improvements in glycemia, knee osteoarthritis pain, and obstructive sleep apnea, with many individuals reaching what are classified as healthy-range weight and normal blood sugar levels. These findings demonstrate what may be possible when we treat obesity and impact overall health, and what this could mean for people living with obesity and its related complications."TRIUMPH-1 included an overarching trial for adults with obesity and two nested basket trials: one for knee osteoarthritis pain and one for moderate-to-severe obstructive sleep apnea. Retatrutide met the primary endpoints in each trial at 80 weeks, delivering powerful weight loss along with significant improvements in knee osteoarthritis pain and obstructive sleep apnea. Participants on retatrutide 9 mg and 12 mg lost an average of 64.4 lbs (25.9%) and 70.3 lbs (28.3%), respectively, while those on the 4 mg dose, reached with a single dose escalation step, lost an average of 47.2 lbs (19.0%).3 Notably, 65.3% of participants on retatrutide 12 mg achieved a BMI

Anyone seeing LLY possibly buy any of the three major psychedelic companies? CMPS, DFTX or ATAI?

TD Cowen Lifts GLP-1 Market Outlook, Sees Global Sales Reaching $150 Billion by 2030June 5, 2026 9:39 AM
IH Market News TD Cowen has raised its long-term forecast for the global GLP-1 market, projecting annual sales of diabetes and obesity treatments in the category will reach $150 billion by 2030. The revised estimate marks an increase from the firm’s previous forecast of $139 billion, reflecting stronger expectations for patient adoption and continued expansion of the market. Patient Numbers Expected to Grow Significantly The brokerage now anticipates that approximately 59 million people worldwide will be using GLP-1 therapies by the end of the decade. That compares with its earlier projection of 46 million patients, highlighting expectations for broader access to treatment and increasing demand for weight-management and diabetes medications. According to TD Cowen, growth in patient volumes should more than offset pricing pressures expected across the sector. Lower Prices Seen Driving Wider Adoption The firm noted that future price reductions are likely to be accompanied by substantial increases in treatment uptake. As manufacturers expand production capacity and competition intensifies, lower pricing could help make GLP-1 therapies accessible to a larger patient population, supporting continued market growth despite potential pressure on revenue per prescription. Oral Treatments Poised to Capture Larger Share TD Cowen also upgraded its outlook for oral GLP-1 medications, which are expected to become an increasingly important segment of the market. The firm now forecasts that oral formulations will account for 14% of global GLP-1 sales by 2030, compared with its previous estimate of 11%. The growing role of pill-based treatments reflects expectations that some patients and healthcare providers will favor oral alternatives over injectable therapies when clinically appropriate. Eli Lilly and Novo Nordisk Expected to Remain Dominant Despite the arrival of new competitors, TD Cowen expects the market to remain heavily concentrated among the current industry leaders. Eli Lilly (NYSE:LLY) is projected to hold approximately 62% of the global GLP-1 market by value in 2030, while Novo Nordisk (NYSE:NVO) is expected to account for roughly 31%. Together, the two pharmaceutical companies are forecast to control the overwhelming majority of industry sales as demand for obesity and diabetes treatments continues to accelerate worldwide. Obesity and Diabetes Markets Continue to Expand The revised forecast underscores growing confidence in the long-term potential of GLP-1 therapies, which have transformed treatment options for both Type 2 diabetes and obesity. With patient adoption expected to increase substantially over the coming years, the sector remains one of the fastest-growing areas within the global pharmaceutical industry. Eli Lilly stock price Novo Nordisk stock price Original: TD Cowen Lifts GLP-1 Market Outlook, Sees Global Sales Reaching $150 Billion by 2030

Weight Watchers Expands Reach Through LillyDirect Partnership (WW)June 4, 2026 10:05 AM
IH Market News WW International (NASDAQ:WW) has integrated its Weight Watchers Med+ offering with Eli Lilly’s (NYSE:LLY) LillyDirect healthcare platform, broadening access to its clinical weight management services for patients using or considering prescription obesity treatments. The collaboration connects LillyDirect users with Weight Watchers’ program, which combines GLP-1 medications with behavioral, nutritional and lifestyle support. Med+ Program Added to LillyDirect Ecosystem Through the integration, patients using LillyDirect will be able to access Weight Watchers Med+, a program designed to provide medical oversight alongside structured support for long-term weight management. LillyDirect offers patients access to independent healthcare providers, prescription fulfillment resources and educational content, while Weight Watchers Med+ adds clinical care, coaching and community-based support. The combined approach is intended to help patients manage their treatment journey beyond simply receiving a prescription. Focus on Clinical and Behavioral Support Weight Watchers said its Med+ platform is designed for a broad range of patients, including those evaluating weight-loss medications, individuals already taking GLP-1 therapies and people seeking ongoing support for weight management. The program integrates care from licensed healthcare professionals with nutritional guidance, behavioral coaching and lifestyle-focused resources. It also includes the company’s GLP-1 Success programme, which aims to help patients maximize the effectiveness of prescribed treatments while maintaining long-term health goals. Management Highlights Importance of Patient Access “A seamless connection from LillyDirect is central to expanding access while ensuring patients are supported beyond the prescription,” said Scott Honken, Chief Commercial Officer at Weight Watchers. “Weight Watchers Med+ is designed to support patients with the clinical and behavioral care they need to navigate weight health in real life.” The company believes the partnership can help improve patient outcomes by pairing medication access with ongoing engagement and support. Building on the Growth of GLP-1 Treatments The integration comes amid growing demand for GLP-1 weight-loss medications and increasing interest in comprehensive care models that combine pharmaceutical treatments with behavioral health services. Weight Watchers describes itself as a science-backed weight management company and has been providing weight-related health programmes for more than six decades. In addition to its direct-to-consumer offerings, the company also works with employers and healthcare plans through its Weight Watchers for Business platform, extending its services across a broader healthcare ecosystem. WW International stock price Eli Lilly stock price Original: Weight Watchers Expands Reach Through LillyDirect Partnership (WW)

Lilly to spotlight growing hematology portfolio at 2026 European Hematology Association (EHA) Annual MeetingJune 2, 2026 9:30 AM
PR Newswire (US) Positive results from the Phase 3 BRUIN CLL-322 study comparing time-limited pirtobrutinib plus venetoclax and rituximab versus venetoclax and rituximab in patients with relapsed or refractory CLL/SLL will be highlighted in a late-breaking oral presentationAjax Therapeutics, which Lilly has agreed to acquire, will present the first clinical data for its first-in-class type II JAK2 inhibitor for patients with myelofibrosis who have been failed by a type I JAK2 inhibitorKelonia Therapeutics, which Lilly has agreed to acquire, will present additional correlative clinical data for its in vivo CAR-T program in patients with multiple myeloma INDIANAPOLIS, June 2, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the details of presentations at the European Hematology Association (EHA) Annual Meeting, taking place June 11-14 in Stockholm, Sweden.Data to be highlighted include an oral presentation detailing results from the Phase 3 BRUIN CLL-322 study of Jaypirca (pirtobrutinib), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, as part of a time-limited regimen for patients with previously treated chronic lymphocytic leukemia (CLL). Lilly is strengthening its hematology portfolio through the recently announced proposed acquisitions of Ajax Therapeutics, Inc.* and Kelonia Therapeutics, Inc.*, each of which will present data at the meeting. Ajax Therapeutics will present the first clinical data from the Phase 1 AJX-101 study evaluating AJ1-11095, an investigational first-in-class type II JAK2 inhibitor, in patients with myelofibrosis who have been failed by a type I JAK2 inhibitor. Kelonia Therapeutics will present additional correlative data from the Phase 1 inMMyCAR study of an investigational anti-B-cell maturation antigen (BCMA) targeted in vivo CAR-T therapy in patients with relapsed and refractory multiple myeloma. Both proposed acquisitions by Lilly are pending transaction closes."These data at EHA represent a significant moment for Lilly's hematology ambitions," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "The Phase 3 BRUIN CLL-322 results address an important question for patients with relapsed or refractory CLL, demonstrating that time-limited pirtobrutinib can meaningfully improve outcomes when added to an already effective venetoclax-based regimen. Alongside the first clinical data from Ajax and additional results from Kelonia in support of the recently presented data at ASCO, these results reflect our relentless commitment to pursue meaningful advancements for people living with blood disorders."Presentation Highlights:Lilly:In a late-breaking oral presentation, Lilly will share results from the Phase 3 BRUIN CLL-322 study, evaluating a time-limited regimen of pirtobrutinib plus venetoclax and rituximab versus venetoclax and rituximab in patients with relapsed or refractory CLL/SLL. BRUIN CLL-322 is the first Phase 3 readout in CLL to outperform a venetoclax-containing control arm in any CLL setting. Lilly previously announced that the study met its primary endpoint, demonstrating that the addition of pirtobrutinib to venetoclax plus rituximab led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS). These results were also selected to be featured in the EHA press program.Ajax Therapeutics:In an oral presentation, Ajax will share the first clinical results from the Phase 1 AJX-101 clinical trial, evaluating AJ1-11095, an investigational first-in-class type II JAK2 inhibitor, in patients with myelofibrosis who have been failed by a type I JAK2 inhibitor. These data will also be featured in the EHA press program.  Kelonia Therapeutics:In an oral presentation, Kelonia will share additional correlative data from the Phase 1 inMMyCAR dose-escalation study, evaluating KLN-1010 in relapsed or refractory multiple myeloma. Data from this study were recently shared at the American Society of Clinical Oncology (ASCO) Annual Meeting.  A full list of abstract titles and viewing details are listed below:Abstract TitleAuthorPresentation Type/#Session TitleSession Date/Time (CEST) Jaypirca (pirtobrutinib; non-covalent BTK inhibitor)Fixed-duration pirtobrutinib plus venetoclax–rituximab versus venetoclax–rituximab for patients with previously treated CLL/SLL: A phase 3, randomized study (BRUIN CLL-322)Matthew DavidsOral#LB5001Late-breaking oral sessionSunday, June 149:15 – 10:45Pirtobrutinib in treatment-naïve patients with CLL/SLL: Pooled results from BRUIN CLL-313 and BRUIN CLL-314Jennifer WoyachPoster#PS1701Chronic lymphocytic leukemia and related disorders - ClinicalSaturday, June 13 18:45 – 19:45Patient-reported outcomes of pirtobrutinib vs. bendaR in untreated CLL/SLL: Findings from BRUIN-CLL-313 Phase 3 studyTomasz WrobelPoster #PF1386Quality of life, ethics, supportive and palliative careFriday, June 12 18:45 - 19:45 Investigator InitiatedA Phase 2 study of fixed-duration pirtobrutinib and obinutuzumab in previously untreated CLLInhye E. AnnOral Session #S148Prognostication and first line therapy in CLLFriday, June 1218:00 – 18:15 AJ1-11095 (Ajax's investigational first-in-class type II JAK2 inhibitor)Results of AJX-101, a Phase 1 clinical trial of the type II JAK2 inhibitor AJ1-11095, in patients with myelofibrosis who have been failed by a type I JAK2 inhibitorJohn MascarehasOral Session#S218Myeloproliferative neoplasms - ClinicalSaturday, June 1318:00 – 18:15 KLN-1010 (Kelonia's investigational in vivo CAR-T therapy)Successful in vivo CAR-T generation and minimal residual disease (MRD) clearance with KLN-1010 across diverse baseline T Cell phenotypes in relapsed/refractory multiple myeloma (RRMM)Andrew SpencerOral Session#S185T cell redirected therapy in multiple myelomaThursday, June 1116:45 – 17:00





For more information on Lilly's oncology pipeline click here.*Lilly and Ajax Therapeutics, Inc., and Lilly and Kelonia Therapeutics, Inc., remain separate, independent companies prior to closing. Both transactions are subject to customary closing conditions, including regulatory approvals, with Ajax Therapeutics expected to close in June 2026 and Kelonia Therapeutics expected to close in the second half of 2026.About Jaypirca (pirtobrutinib) 
Jaypirca (pirtobrutinib) (pronounced jay-pihr-kaa) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent inhibitor of the enzyme BTK.1 BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).2,3 Jaypirca is a U.S. FDA-approved oral prescription medicine, 100 mg or 50 mg tablets taken as a once-daily 200 mg dose with or without food until disease progression or unacceptable toxicity.INDICATIONS FOR JAYPIRCA (pirtobrutinib)
Jaypirca is indicated for the treatment ofAdult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor.Adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. IMPORTANT SAFETY INFORMATION FOR JAYPIRCA (pirtobrutinib)Infections: Fatal and serious infections (including bacterial, viral, fungal) and opportunistic infections occurred in Jaypirca-treated patients. Across clinical trials, Grade ≥3 infections occurred (25%), most commonly pneumonia (20%); fatal infections (5%), sepsis (6%), and febrile neutropenia (3.8%) occurred. In patients with CLL/SLL, Grade ≥3 infections occurred (32%), with fatal infections occurring in 8%. Opportunistic infections included Pneumocystis jirovecii pneumonia and fungal infection. Consider prophylaxis, including vaccinations and antimicrobial prophylaxis, in patients at increased risk for infection, including opportunistic infections. Monitor for signs and symptoms, evaluate, and treat. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.Hemorrhage: Fatal and serious hemorrhage has occurred with Jaypirca. Across clinical trials, major hemorrhage (Grade ≥3 bleeding or any central nervous system bleeding) occurred (2.6%), including gastrointestinal hemorrhage; fatal hemorrhage occurred (0.3%). Bleeding of any grade, excluding bruising and petechiae, occurred (16%). Major hemorrhage occurred when taking Jaypirca with (2.0%) and without (0.6%) antithrombotic agents. Consider risks/benefits of co-administering antithrombotic agents with Jaypirca. Monitor for signs of bleeding. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca. Consider withholding Jaypirca 3-7 days pre- and post-surgery based on surgery type and bleeding risk.Cytopenias: Jaypirca can cause cytopenias, including neutropenia, thrombocytopenia, and anemia. Across clinical trials, Grade 3 or 4 cytopenias, including decreased neutrophils (27%), decreased platelets (13%), and decreased hemoglobin (11%), developed. Grade 4 decreased neutrophils (15%) and Grade 4 decreased platelets (6%) developed. Monitor complete blood counts regularly. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.Cardiac Arrhythmias: Cardiac arrhythmias occurred in patients taking Jaypirca. Across clinical trials, atrial fibrillation or flutter were reported in 3.4% of Jaypirca treated patients, with Grade 3 or 4 atrial fibrillation or flutter in 1.6%. Other serious cardiac arrhythmias such as supraventricular tachycardia and cardiac arrest occurred (0.4%). Cardiac risk factors such as hypertension or previous arrhythmias may increase risk. Monitor and manage signs and symptoms of arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea). Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.Second Primary Malignancies: Across clinical trials, second primary malignancies, including non-skin carcinomas, developed in 9% of Jaypirca-treated patients, most frequently non-melanoma skin cancer (4.4%). Other second primary malignancies included solid tumors (including genitourinary and breast cancers) and melanoma. Advise patients to use sun protection and monitor for development of second primary malignancies.Hepatotoxicity, Including Drug-Induced Liver Injury (DILI): Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of DILI, has occurred in patients treated with BTK inhibitors, including Jaypirca. Evaluate bilirubin and transaminases at baseline and throughout Jaypirca treatment. For patients who develop abnormal liver tests after Jaypirca, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold Jaypirca. If DILI is confirmed, discontinue Jaypirca.Embryo-Fetal Toxicity: Jaypirca can cause fetal harm. Administration of pirtobrutinib to pregnant rats caused embryo-fetal toxicity, including embryo-fetal mortality and malformations at maternal exposures (AUC) approximately 3-times the recommended 200 mg/day dose. Advise pregnant women of fetal risk and females of reproductive potential to use effective contraception during treatment and for one week after last dose.Adverse Reactions (ARs) in Patients Who Received JaypircaThe most common (≥30%) ARs in the pooled safety population of patients with hematologic malignancies (n=704) were decreased neutrophil count (54%), decreased hemoglobin (43%), decreased leukocytes (32%), fatigue (31%), decreased platelets (31%), decreased lymphocyte count (31%), calcium decreased (30%).Mantle Cell LymphomaSerious ARs occurred in 38% of patients, with pneumonia (14%), COVID-19 (4.7%), musculoskeletal pain (3.9%), hemorrhage (2.3%), pleural effusion (2.3%), and sepsis (2.3%) occurring in ≥2% of patients. Fatal ARs within 28 days of last dose occurred in 7% of patients, most commonly due to infections (4.7%), including COVID-19 (3.1% of all patients).Dose Modifications and Discontinuations Due to ARs: Dose reductions in 4.7%, treatment interruption in 32%, and permanent discontinuation of Jaypirca in 9% of patients. Permanent discontinuation in >1% of patients included pneumonia.Most common ARs (≥15%) and Select Laboratory Abnormalities (≥10%) (all Grades %; Grade 3-4 %): hemoglobin decreased (42; 9), platelet count decreased (39; 14), neutrophil count decreased (36; 16), lymphocyte count decreased (32; 15), creatinine increased (30; 1.6), fatigue (29; 1.6), musculoskeletal pain (27; 3.9), calcium decreased (19; 1.6), diarrhea (19; -), edema (18; 0.8), dyspnea (17; 2.3), AST increased (17; 1.6), pneumonia (16; 14), bruising (16; -), potassium decreased (13; 1.6), sodium decreased (13; -), lipase increased (12; 4.4), ALT increased (11; 1.6), potassium increased (11; 0.8), alkaline phosphatase increased (11; -). Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (10), platelets decreased (7), lymphocytes decreased (6).Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma from Single-Arm and Randomized Controlled Clinical Trials Serious ARs occurred in 47-56% of patients across clinical trials. Serious ARs in ≥5% of patients in the single-arm trial were pneumonia (18%), COVID-19 (9%), sepsis (7%), febrile neutropenia (7%). Serious ARs in ≥3% of patients in the randomized controlled trial were pneumonia (21%), COVID-19 (5%), sepsis (3.4%). Fatal ARs within 28-30 days of last Jaypirca dose occurred in 8-11% of patients, most commonly due to infections (7-10%), including sepsis (5%), COVID-19 (2.7-5%), and pneumonia (3.4%).Dose Modifications and Discontinuations Due to ARs: Dose reductions in 3.6-10%, treatment interruption in 42-51%, and permanent discontinuation of Jaypirca in 9-17% of patients. Permanent discontinuation in >1% of patients included second primary malignancy, pneumonia, COVID-19, neutropenia, sepsis, anemia, and cardiac arrhythmias.Most common ARs and Select Laboratory Abnormalities (≥20%) (all Grades %, Grade 3-4 %)--in a randomized controlled trial: neutrophil count decreased (54; 26), hemoglobin decreased (45; 10), platelet count decreased (37; 17), pneumonia (28; 16), ALT increased (25; 1.8), creatinine increased (25; -), calcium decreased (23; 0.9), sodium decreased (22; 0.9), bilirubin increased (21; 0.9), upper respiratory tract infections (21; 0.9); in a single-arm trial: neutrophil count decreased (63; 45), hemoglobin decreased (48; 19), calcium decreased (40; 2.8), fatigue (36; 2.7), bruising (36; -), cough (33; -), musculoskeletal pain (32; 0.9), platelet count decreased (30; 15), sodium decreased (30; -), COVID-19 (28; 7), pneumonia (27; 16), diarrhea (26; -), abdominal pain (25; 2.7), lymphocyte count decreased (23; 8), ALT increased (23; 2.8), AST increased (23; 1.9), creatinine increased (23; -), dyspnea (22; 2.7), hemorrhage (22; 2.7), lipase increased (21; 7), alkaline phosphatase increased (21; -), edema (21; -), nausea (21; -), pyrexia (20; 2.7), headache (20; 0.9). Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (23).Drug InteractionsStrong CYP3A Inhibitors: Concomitant use increased pirtobrutinib systemic exposure, which may increase risk of Jaypirca ARs. Avoid using strong CYP3A inhibitors with Jaypirca. If concomitant use is unavoidable, reduce Jaypirca dose according to approved labeling.Strong or Moderate CYP3A Inducers: Concomitant use decreased pirtobrutinib systemic exposure, which may reduce Jaypirca efficacy. Avoid using Jaypirca with strong or moderate CYP3A inducers. If concomitant use with moderate CYP3A inducers is unavoidable, increase Jaypirca dose according to approved labeling.Sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP Substrates: Use with Jaypirca increased their plasma concentrations, which may increase risk of ARs related to these substrates for drugs sensitive to minimal concentration changes. Follow recommendations for these sensitive substrates in their approved labeling.Use in Specific PopulationsPregnancy and Lactation: Due to potential for Jaypirca to cause fetal harm, verify pregnancy status in females of reproductive potential prior to starting Jaypirca. Presence of pirtobrutinib in human milk is unknown. Advise women to use effective contraception and to not breastfeed while taking Jaypirca and for one week after last dose.Geriatric Use: In the pooled safety population of patients with hematologic malignancies, patients aged ≥65 years experienced higher rates of Grade ≥3 ARs and serious ARs compared to patients

Lilly Reports Strong Phase 3 Results for Retevmo in Early-Stage Lung Cancer (LLY)June 1, 2026 5:37 AM
IH Market News Eli Lilly and Company (NYSE:LLY) announced positive data from its Phase 3 LIBRETTO-432 trial, showing that Retevmo significantly lowered the risk of disease recurrence or death in patients with early-stage RET fusion-positive non-small cell lung cancer (NSCLC) following initial treatment. The study found that treatment with Retevmo (selpercatinib) reduced the risk of recurrence or death by 83% compared with placebo, highlighting the drug’s potential role as an adjuvant therapy for patients with RET-driven lung cancer. Trial Assessed Retevmo Following Surgery or Radiation The LIBRETTO-432 trial enrolled 151 patients with stage IB to IIIA RET fusion-positive NSCLC who had previously undergone surgery or radiation therapy. Participants were randomly assigned to receive either selpercatinib at a dose of 160mg twice daily or a placebo, with treatment continuing for up to three years. The objective was to determine whether Retevmo could improve outcomes by reducing the likelihood of disease recurrence after initial treatment. Event-Free Survival Significantly Improved The primary analysis focused on 109 patients with stage II to IIIA disease and demonstrated a substantial benefit for those receiving selpercatinib. Investigator-assessed event-free survival strongly favored the treatment group, with a hazard ratio of 0.17. After a median follow-up period of 24 months, the event-free survival rate at two years reached 92% among patients treated with Retevmo, compared with 61% for those receiving placebo. Median event-free survival had not yet been reached in the selpercatinib group at the time of analysis, whereas patients in the placebo arm recorded a median event-free survival of 31.8 months. Safety Profile Remained Manageable The safety findings were broadly consistent with the known profile of the drug. Among adverse events classified as Grade 3 or higher, increased alanine aminotransferase levels were reported in 17% of patients receiving selpercatinib, compared with 1% in the placebo group. Elevated aspartate aminotransferase levels occurred in 19% of patients treated with Retevmo, versus 3% among placebo recipients. According to Lilly, these side effects were manageable through dose adjustments and treatment modifications. Findings to Be Presented at ASCO and Published in Medical Journal The company said the results will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and published simultaneously in the New England Journal of Medicine. The trial represents the first randomized Phase 3 study to investigate a selective RET kinase inhibitor as adjuvant therapy for patients with RET fusion-positive NSCLC. Lilly Preparing Regulatory Submissions Following the positive outcome of LIBRETTO-432, Lilly intends to submit the data package to health regulators around the world for review. If approved, Retevmo could become an important treatment option for patients with early-stage RET fusion-positive lung cancer, potentially helping to reduce the risk of recurrence after surgery or radiation therapy and improving long-term outcomes in this genetically defined patient population. Eli Lilly stock price Original: Lilly Reports Strong Phase 3 Results for Retevmo in Early-Stage Lung Cancer (LLY)

Lilly's Retevmo (selpercatinib) demonstrated an 83% reduction in the risk of disease recurrence or death as adjuvant therapy for people with early-stage RET fusion-positive lung cancerMay 31, 2026 8:01 AM
PR Newswire (US) Phase 3 LIBRETTO-432 results establish RET fusions alongside EGFR mutations and ALK fusions as biomarkers in early-stage lung cancer that are associated with dramatic treatment outcomes, underscoring the importance of comprehensive biomarker testing across all stages of disease These data will be published in the New England Journal of Medicine and simultaneously presented during the Plenary Session at the 2026 ASCO Annual MeetingINDIANAPOLIS, May 31, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced results from the Phase 3 LIBRETTO-432 clinical trial of Retevmo (selpercatinib) as adjuvant therapy versus placebo in patients with early-stage (IB-IIIA) rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in investigator-assessed event-free survival (EFS) with selpercatinib reducing the risk of disease recurrence or death by 83% versus placebo in the primary analysis population.These data will be simultaneously published in the New England Journal of Medicine and presented during the Plenary Session at the 2026 ASCO Annual Meeting taking place in Chicago, Illinois, as well as featured in the meeting's press program."Patients with early-stage RET fusion-positive lung cancer face high recurrence risk, yet unlike those with EGFR or ALK alterations, have lacked a proven targeted treatment option," said Jonathan Goldman, M.D., Professor of Medicine and Director of Clinical Trials at University of California, Los Angeles. "These LIBRETTO-432 results provide strong evidence that treating with selpercatinib after surgery or radiation can significantly lower that risk. The magnitude of benefit seen from adjuvant treatment with selpercatinib reinforces that comprehensive genomic testing at diagnosis is essential for all people with lung cancer and could lead to changes in clinical practice for treating early-stage RET-positive disease."LIBRETTO-432 is the first and only randomized Phase 3 study to evaluate the safety and efficacy of a selective RET kinase inhibitor as adjuvant therapy in this population. The trial enrolled 151 patients who were randomized 1:1 to receive selpercatinib 160mg twice daily or placebo for up to three years following completion of definitive radiotherapy or surgery with curative intent with or without adjuvant chemotherapy.At a median follow-up of 24 months, investigator-assessed EFS in the primary analysis population (patients with stage II-IIIA disease, n=109) was significantly improved with selpercatinib compared to placebo (HR: 0.17 [95% CI, 0.06 to 0.51]; p

Lilly to present new data on Foundayo, Mounjaro and retatrutide at the American Diabetes Association's 86th Scientific Sessions, building toward a new era of choice in diabetes and obesity careMay 28, 2026 1:00 PM
PR Newswire (US) Phase 3 ACHIEVE results showed Foundayo, an oral GLP-1 taken without food or water restrictions, outperformed oral semaglutide and dapagliflozin in type 2 diabetes, reinforcing its potential to redefine oral incretin therapyNew analyses of the ATTAIN program highlight Foundayo's profile in patient populations central to the future of cardiometabolic care, including women at every stage of menopausePivotal Phase 3 results showed retatrutide, a first-in-class triple receptor agonist, delivered powerful results in obesity, type 2 diabetes and other complicationsINDIANAPOLIS, May 28, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY), the maker of Zepbound (tirzepatide), Mounjaro (tirzepatide), Foundayo (orforglipron) and retatrutide, will present new data across its cardiometabolic portfolio at the American Diabetes Association's 86th Scientific Sessions taking place June 5-8 in New Orleans. Together, these findings position Lilly to lead the next era of cardiometabolic care, with a differentiated suite of approved and investigational medicines built to expand choice for the millions living with obesity, diabetes and related conditions."No two patients with obesity or diabetes are alike, and their needs evolve over time. That's exactly why choice matters," said Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health. "The data we're presenting at ADA, including pivotal Phase 3 results for retatrutide and Foundayo, the only oral GLP-1 taken without food or water restrictions, demonstrate our ability to meet patients wherever they are and wherever they're headed."Lilly will also host an investor event on Saturday, June 6, at 6:00 p.m. CDT to highlight the company's cardiometabolic health portfolio and discuss key disclosures from the meeting. The event will be accessible via a live webcast on the "Webcasts & Presentations" section of Lilly's investor website. A replay will be available on the website following the event.Select Lilly Presentations at ADA 2026Retatrutide symposium | Saturday, June 6, 2026 | 1:30–3:00 p.m. CDTThis ADA-sponsored symposium will present Phase 3 results for retatrutide, an investigational once-weekly GIP, GLP-1, and glucagon triple receptor agonist, across two studies:TRIUMPH-1: Retatrutide delivered powerful weight loss of up to an average of 70.3 lbs (28.3%) at 80 weeks in adults with obesity.TRANSCEND-T2D-1: Retatrutide lowered A1C by up to an average of 2.0% and weight by up to an average of 36.6 lbs (16.8%) at 40 weeks in adults with type 2 diabetes.Foundayo (orforglipron) symposium | Monday, June 8, 2026 | 1:30–3:00 p.m. CDTThis ADA-sponsored symposium will present Phase 3 results for Foundayo (orforglipron), the only oral GLP-1 taken without food or water restrictions, across three studies in the ACHIEVE type 2 diabetes program:ACHIEVE-2: Foundayo lowered A1C by up to 1.7% compared to 0.8% with dapagliflozin at 40 weeks.ACHIEVE-3: Foundayo was superior to oral semaglutide in type 2 diabetes, delivering better A1C reduction and 73.6% greater relative weight loss at 52 weeks.1ACHIEVE-5: Foundayo lowered A1C by up to 2.1% compared to 0.8% with placebo when taken with insulin glargine at 40 weeks.Foundayo (orforglipron) postersATTAIN-1 and ATTAIN-2 Subgroup Analysis: Foundayo was associated with significant weight loss across all stages of menopause, including more than 14% weight reduction in women with peri-menopause or post-menopause in ATTAIN-1.ATTAIN-1 Post-Hoc Analysis: Foundayo was associated with meaningful improvements in markers of insulin sensitivity and beta-cell function in adults with obesity, regardless of pre-diabetes status.Mounjaro (tirzepatide) postersSURPASS-CVOT: Mounjaro and dulaglutide demonstrated improvements in quality of life and daily functioning over the course of multiple years of treatment.SURPASS-EARLY: Mounjaro improved physical, psychosocial, and quality-of-life outcomes in adults with early type 2 diabetes.About Zepbound (tirzepatide) injection
Zepbound (tirzepatide) is the first and only dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist obesity medication. Zepbound tackles an underlying cause of excess weight. It reduces appetite and how much you eat. Zepbound is indicated for adults with obesity, or some adults who are overweight and also have at least one weight-related medical problem, to lose weight and keep it off. Additionally, Zepbound is FDA-approved to treat adults with moderate-to-severe obstructive sleep apnea and obesity. Zepbound should be used with a reduced-calorie diet and increased physical activity. About Mounjaro (tirzepatide) injection
Mounjaro (tirzepatide) is an injectable medicine for adults and children 10 years of age and older with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose). As the first and only FDA-approved GIP and GLP-1 receptor agonist, Mounjaro is a single molecule that activates the body's receptors for GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1). It is not known if Mounjaro is safe and effective for use in children under 10 years of age.About Foundayo (orforglipron)  
Foundayo (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems, to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.2 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, orforglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.About retatrutide
Retatrutide is an investigational once-weekly triple hormone receptor agonist. Retatrutide is a single molecule that activates the body's receptors for glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), and glucagon. Lilly is studying retatrutide in several Phase 3 clinical trials to evaluate its potential efficacy and safety in obesity and overweight with at least one weight-related medical problem, type 2 diabetes, knee osteoarthritis, moderate-to-severe obstructive sleep apnea, chronic low back pain, cardiovascular and renal outcomes, and metabolic dysfunction-associated steatotic liver disease. Retatrutide is an investigational molecule that is legally available only to participants in Lilly's clinical trials.Endnotes and ReferencesRelative weight loss reflects a comparison of Foundayo 17.2 mg vs. oral semaglutide 14 mg.Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. https://doi.org/10.1007/s13300-024-01554-1. Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152.ZEPBOUND INDICATIONS AND SAFETY SUMMARY WITH WARNINGSZepbound® (ZEHP-bownd) is an injectable prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with:obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA.Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children.Warnings - Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound.KwikPen®: Do not share your KwikPen with other people, even if the pen needle has been changed.  You may give other people a serious infection or get a serious infection from them.Zepbound may cause serious side effects, including:Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away.Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. You may feel the pain from your abdomen to your back.Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery.Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound.Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures.Common side effects
The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch. Before using ZepboundYour healthcare provider should show you how to use Zepbound before you use it for the first time.Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound.Review these questions with your healthcare provider:? Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
? Do you take diabetes medicines, such as insulin or sulfonylureas?
? Do you have a history of diabetic retinopathy?
? Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
? Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
? Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound.Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Lilly at 1-800-LillyRx (1-800-545-5979).How to takeRead the Instructions for Use that come with Zepbound.Use Zepbound exactly as your healthcare provider says.Use Zepbound with a reduced-calorie diet and increased physical activity.Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen), thigh, or have another person inject in the back of the upper arm. Do not inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously).Use Zepbound 1 time each week, at any time of the day.Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.Zepbound is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg injection.Learn more
Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to www.zepbound.lilly.com.This summary provides basic information about Zepbound but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you.ZP CON BS 25FEB2026MOUNJARO INDICATION AND SAFETY SUMMARY WITH WARNINGS
Mounjaro (mown-JAHR-OH) is an injectable medicine for adults and children 10 years of age and older with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose).It is not known if Mounjaro is safe and effective for use in children under 10 years of age.Warnings - Mounjaro may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.Do not use Mounjaro if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).Do not use Mounjaro if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).Do not use Mounjaro if you are allergic to it or any of the ingredients in Mounjaro.Mounjaro may cause serious side effects, including:Inflammation of the pancreas (pancreatitis). Stop using Mounjaro and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Mounjaro with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness and feeling jittery.Serious allergic reactions. Stop using Mounjaro and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Mounjaro. Tell your healthcare provider if you have stomach problems that are severe or will not go away.Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Mounjaro.Gallbladder problems. Gallbladder problems have happened in some people who use Mounjaro. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), and clay-colored stools.Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Mounjaro may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Mounjaro before you are scheduled to have surgery or other procedures.Common side effectsThe most common side effects of Mounjaro include nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and stomach (abdominal) pain. These are not all the possible side effects of Mounjaro. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.Before using MounjaroYour healthcare provider should show you how to use Mounjaro before you use it for the first time.Talk to your healthcare provider about low blood sugar and how to manage it.If you take birth control pills by mouth, talk to your healthcare provider before you use Mounjaro. Birth control pills may not work as well while using Mounjaro. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Mounjaro and for 4 weeks after each increase in your dose of Mounjaro.Review these questions with your healthcare provider:? Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
? Do you take other diabetes medicines, such as insulin or sulfonylureas?
? Do you have a history of diabetic retinopathy?
? Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
? Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? It is not known if Mounjaro will harm your unborn baby. Mounjaro may pass into your breast milk.
? Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?How to takeRead the Instructions for Use that come with Mounjaro.Use Mounjaro exactly as your healthcare provider says.A caregiver may give you Mounjaro injections, or you may self-inject if a healthcare provider determines that it is appropriate.Inject Mounjaro under the skin (subcutaneously) of your stomach (abdomen), thigh, or another person should inject in the back of the upper arm. Do not inject Mounjaro into a muscle (intramuscularly) or vein (intravenously).Use Mounjaro 1 time each week, at any time of the day. Do not mix insulin and Mounjaro together in the same injection.You may give an injection of Mounjaro and insulin in the same body area (such as your stomach area), but not right next to each other.Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.If you take too much Mounjaro, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.Learn more
Mounjaro is a prescription medicine available as a pre-filled single-dose pen in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL injection. For more information, call 1-800-LillyRX (800-545-5979) [or go to www.mounjaro.lilly.com].This summary provides basic information about Mounjaro but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Mounjaro and how to take it. Your healthcare provider is the best person to help you decide if Mounjaro is right for you.TR CON BS  19DEC2025Mounjaro® and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.FOUNDAYO INDICATION AND SAFETY SUMMARY WITH WARNINGS
Foundayo (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.Foundayo should not be used with other GLP-1 receptor agonist medicines.It is not known if Foundayo is safe and effective for use in children.Warnings – Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo.Foundayo may cause serious side effects, including:Inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away.Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery.Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo.Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures.Common side effects
The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.Before taking FoundayoTell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works.Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo.Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.Review these questions with your healthcare provider:? Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
? Do you have a history of diabetic retinopathy?
? Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
? Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby.
? Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo.
? Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements?How to takeTake Foundayo exactly as your healthcare provider tells you to.Use Foundayo with a reduced-calorie diet and increased physical activity.Take Foundayo by mouth 1 time each day, with or without food.Swallow tablets whole. Do not break, crush, or chew the tablet.If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day.Do not take more than 1 tablet per day.If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment.If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.Learn more
Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com.TRULICITY INDICATION AND SAFETY SUMMARY WITH WARNINGS
Trulicity (Tr?-li-si-tee) is for adults and children 10 years of age and older with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose). Trulicity is also used in adults with type 2 diabetes to reduce the risk of major cardiovascular events (problems having to do with the heart and blood vessels) such as death, heart attack, or stroke in people who have heart disease or multiple cardiovascular risk factors.It is not known if Trulicity is safe and effective to lower blood sugar (glucose) in children under 10 years of age.Trulicity is given through an injection (needle). You take it once a week by injecting it under the skin of your stomach, thigh, or upper arm.Warnings: Trulicity may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, trouble swallowing, hoarseness, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.Do not use Trulicity if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).Do not use Trulicity if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).Do not use Trulicity if you are allergic to dulaglutide or other ingredients in Trulicity.Ask your healthcare provider how to recognize the serious side effects below and what to do if you think you have one:Inflammation of the pancreas (pancreatitis). Stop using Trulicity and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes, you may feel the pain from your abdomen to your back.Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use TRULICITY with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin.Signs and symptoms of low blood sugar may include dizziness or light-headedness, confusion or drowsiness, headache, blurred vision, slurred speech, fast heartbeat, sweating, hunger, shakiness, feeling jittery, weakness, anxiety, irritability, or mood changes.Serious allergic reactions. Stop using Trulicity and get medical help right away if you have any symptoms of a serious allergic reaction which may include swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting, or feeling dizzy, or very rapid heartbeat.Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Trulicity. Tell your healthcare provider if you have stomach problems that are severe or will not go away.Changes in vision. Tell your healthcare provider if you have changes in your eyesight (vision) during treatment with Trulicity.Gallbladder problems. Gallbladder problems have happened in some people who take Trulicity. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), clay-colored stools.Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Trulicity may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Trulicity before you are scheduled to have surgery or other procedures.Common side effects
The most common side effects of Trulicity include nausea, diarrhea, vomiting, abdominal pain and decreased appetite, indigestion, and fatigue.These are not all the possible side effects of Trulicity.Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.Before usingYour healthcare provider should show you how to use Trulicity before you use it for the first time.Before you use Trulicity, talk to your healthcare provider about low blood sugar and how to manage it.Review these questions with your healthcare provider:Do you have other medical conditions, including problems with your pancreas, kidneys, liver, or stomach, or have a history of diabetic retinopathy (vision problems related to diabetes)?Do you take other diabetes medicines, such as insulin or sulfonylureas?Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?Are you pregnant or plan to become pregnant or breastfeeding or plan to breastfeed?Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?How to takeRead the Instructions for Use that come with Trulicity.Use Trulicity exactly as your healthcare provider says.Inject Trulicity under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject Trulicity into a muscle (intramuscularly) or vein (intravenously).Do not share your Trulicity pen, syringe, or needles with another person.Do not give Trulicity to other people.If you take too much Trulicity, call your healthcare provider or Poison Helpline at 1-800-222-1222 or go to the nearest hospital emergency room right away.Learn more
Trulicity is a prescription medicine available as a pre-filled single-dose pen in 0.75 mg,1.5 mg, 3 mg, or 4.5 mg per 0.5 mL injection. For more information, call 1-800-LillyRx (1-800-545-5979) or go to www.trulicity.lilly.com.This summary provides basic information about Trulicity but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Trulicity and how to take it. Your healthcare provider is the best person to help you decide if Trulicity is right for you.DG CON HL BS 25MAR2026About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLYTrademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995), including about retatrutide and Foundayo (orforglipron) as potential treatments for adults with obesity or type 2 diabetes and the timeline for future readouts, presentations, and other milestones relating to retatrutide and Foundayo and its clinical trials, and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that retatrutide or Foundayo will prove to be safe and effective treatments for relevant indications, that retatrutide will receive regulatory approval or Foundayo will receive additional regulatory approvals, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.Refer to: Niki Biro; niki_biro @penny stock kid-9074 (Media)
Michael Czapar; czapar_michael_c @orion-0983 (Investors) View original content to download multimedia:https://www.prnewswire.com/news-releases/lilly-to-present-new-data-on-foundayo-mounjaro-and-retatrutide-at-the-american-diabetes-associations-86th-scientific-sessions-building-toward-a-new-era-of-choice-in-diabetes-and-obesity-care-302783855.htmlSOURCE Eli Lilly and Company Original: Lilly to present new data on Foundayo, Mounjaro and retatrutide at the American Diabetes Association's 86th Scientific Sessions, building toward a new era of choice in diabetes and obesity care

Eli Lilly shares edge higher after CVS expands coverage for Zepbound obesity drug (LLY)May 28, 2026 8:50 AM
IH Market News Eli Lilly and Company (NYSE:LLY) shares gained about 1% in premarket trading Thursday after CVS Caremark announced it would add the company’s obesity treatment Zepbound to its preferred drug formulary. Lilly said the decision means all three of the largest pharmacy benefit managers in the United States will now provide coverage for the company’s full obesity medicine portfolio. Under the updated coverage plans, CVS Caremark Commercial Template coverage for Foundayo will begin on June 1. Existing Zepbound patients are expected to maintain coverage immediately, with broader access across template plans scheduled to roll out by October 1. The company said eligible commercially insured patients may be able to access both medications for as little as $25 per month. Lilly also noted that Medicare Part D beneficiaries could qualify to pay $50 monthly for obesity medications beginning July 1 through the Medicare GLP-1 Bridge program. Foundayo is currently the only once-daily GLP-1 oral medication approved for weight management that can be taken without restrictions related to meals or water intake. Zepbound remains the most widely prescribed injectable weight-management treatment in the U.S. “For too long, effective obesity treatment has been out of reach for the people who need it,” said Ilya Yuffa, executive vice president and president of Lilly USA and global customer capabilities. The decision marks a notable shift for CVS Caremark, which had previously excluded Zepbound from its preferred drug list. The expanded formulary coverage is expected to significantly increase access to Lilly’s obesity therapies for insured patients across the United States. Eli Lilly stock price Original: Eli Lilly shares edge higher after CVS expands coverage for Zepbound obesity drug (LLY)

Foundayo and Zepbound now covered for millions of AmericansMay 28, 2026 6:45 AM
PR Newswire (US) CVS Caremark begins covering Foundayo June 1 and resumes Zepbound coverage by October 1 Eligible patients may pay as low as $25 a month for their medicineINDIANAPOLIS, May 28, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced an access milestone in obesity care: all three of the nation's largest pharmacy benefit managers (PBMs) will cover Lilly's full obesity medicine portfolio. This significantly expands the number of Americans who can access FDA-approved options through their existing insurance."For too long, effective obesity treatment has been out of reach for the people who need it," said Ilya Yuffa, executive vice president and president of Lilly USA and global customer capabilities. "Not all medicines work the same way for patients. Broader coverage puts real choice in the hands of millions of Americans and their doctors."Lilly has worked across major PBMs to expand coverage for its obesity medicines. With today's news, coverage from CVS Caremark Commercial Template begins June 1 for Foundayo. For current Zepbound patients, coverage continues uninterrupted, and access will broaden across template plans by October 1. For eligible patients with commercial coverage, both medicines are available for as little as $25 a month.* Medicare Part D beneficiaries may also be eligible to pay $50 per month for their obesity medicines beginning July 1 through the Medicare GLP-1 Bridge program.**Foundayo is the only once-daily GLP-1 pill for weight management that can be taken any time of day without food or water restrictions.1 Zepbound is the most-prescribed injectable weight management medicine in the United States.2 Together, they offer patients and their doctors treatment options that fit into people's lives.To check coverage and explore savings options, visit Foundayo.com or Zepbound.com. Coverage information is updated regularly, and people are encouraged to check back often to see the latest coverage and cost information. Talk to your healthcare provider about which treatment option may be right for you.About Zepbound® (tirzepatide) injection
Zepbound® (tirzepatide) is the first and only dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist obesity medication. Zepbound tackles an underlying cause of excess weight. It reduces appetite and how much you eat. Zepbound is indicated for adults with obesity, or some adults who are overweight and also have at least one weight-related medical problem, to lose weight and keep it off. Additionally, Zepbound is FDA-approved to treat adults with moderate-to-severe obstructive sleep apnea and obesity. Zepbound should be used with a reduced calorie diet and increased physical activity.About Foundayo™ (orforglipron)3 
Foundayo™ (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.1 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, orforglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.Warnings - Foundayo and Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.About ATTAIN-1 and ATTAIN-2 clinical trial program
The ATTAIN Phase 3 global clinical development program for orforglipron has enrolled more than 4,500 people with obesity or overweight across two global registration trials.ATTAIN-1 (NCT05869903) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of orforglipron at various doses to placebo in adults with obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease, who did not have diabetes. The trial randomized 3,127 participants across the U.S., Brazil, China, India, Japan, South Korea, Puerto Rico, Slovakia, Spain and Taiwan to receive various doses of orforglipron or placebo along with healthy diet and physical activity. The primary objective of the study was to demonstrate that orforglipron is superior to placebo in body weight reduction from baseline after 72 weeks.ATTAIN-2 (NCT05872620) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of various doses of orforglipron with placebo in adults with obesity or overweight and type 2 diabetes. The trial randomized over 1,600 participants across the U.S., Argentina, Australia, Brazil, China, Czechia, Germany, Greece, India, South Korea and Puerto Rico to receive various doses of orforglipron or placebo along with healthy diet and physical activity. The primary objective of the study was to demonstrate that orforglipron is superior to placebo in mean body weight change from baseline at 72 weeks.Supported by the rigorous ATTAIN clinical trial program, Foundayo, along with diet and exercise, was proven to help people lose weight and keep it off. In the ATTAIN-1 trial, individuals taking the highest dose of Foundayo and who stayed on treatment lost an average of 27.3 pounds (12.4%) compared to 2.2 pounds (0.9%) with placebo.4 Participants taking the highest dose of Foundayo, regardless of trial completion on study drug, lost an average of 25 pounds (11.1%), compared to 5.3 pounds (2.1%) with placebo.5About SURMOUNT-1
Throughout the 72 week clinical trial, people who took Zepbound sustained weight loss—whether taking the 5 mg, 10 mg, or 15 mg dose along with diet and exercise. In a 72-week study of adults without diabetes, average weight loss was 15.0% (34 lbs) for 5 mg, 19.5% (44 lbs) for 10 mg, 20.9% (48 lbs) for 15 mg, and 3.1% (7 lbs) for placebo. Average starting weights were 226.8 lbs for 5 mg, 233.3 lbs for 10 mg, 232.8 lbs for 15 mg, and 231.0 lbs for placebo.INDICATIONS AND SAFETY SUMMARY WITH WARNINGS
Zepbound® (ZEHP-bownd) is an injectable prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with:obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA.Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children.Warnings - Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound.KwikPen®: Do not share your KwikPen with other people, even if the pen needle has been changed. You may give other people a serious infection or get a serious infection from them.Zepbound may cause serious side effects, including:
Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away.Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery.Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound.Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures.Common side effects
The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch. Before using ZepboundYour healthcare provider should show you how to use Zepbound before you use it for the first time.Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound.Review these questions with your healthcare provider:? Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
? Do you take diabetes medicines, such as insulin or sulfonylureas?
? Do you have a history of diabetic retinopathy?
? Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
? Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
? Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound   may harm your unborn baby. Tell your healthcare provider if you become pregnant while using  Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound.Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Lilly at 1-800-LillyRx (1-800-545-5979).How to takeRead the Instructions for Use that come with Zepbound.Use Zepbound exactly as your healthcare provider says.Use Zepbound with a reduced-calorie diet and increased physical activity.Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen), thigh, or have another person inject in the back of the upper arm. Do not inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously).Use Zepbound 1 time each week, at any time of the day.Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.Zepbound is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg injection.Learn more
Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to www.zepbound.lilly.com.This summary provides basic information about Zepbound but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you.ZP CON BS 25FEB2026
Zepbound®, its delivery device base and KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.INDICATION AND SAFETY SUMMARY WITH WARNINGS
Foundayo™ (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.Foundayo should not be used with other GLP-1 receptor agonist medicines.It is not known if Foundayo is safe and effective for use in children.Warnings – Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo.Foundayo may cause serious side effects, including: Inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away.Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery.Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo.Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures.Common side effects
The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.Before taking FoundayoTell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works.Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo.Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.Review these questions with your healthcare provider:? Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
? Do you have a history of diabetic retinopathy?
? Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
? Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby.
? Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo.
? Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements?How to takeTake Foundayo exactly as your healthcare provider tells you to.Use Foundayo with a reduced-calorie diet and increased physical activity.Take Foundayo by mouth 1 time each day, with or without food.Swallow tablets whole. Do not break, crush, or chew the tablet.If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day.Do not take more than 1 tablet per day.If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment.If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.Learn more
Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com.This summary provides basic information about Foundayo but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you.OG CON BS APR2026
Foundayo™ is a trademark of Eli Lilly and Company.Endnotes and References
*Terms and conditions apply. For Zepbound, available with auto-injector presentation.
**For further details regarding Medicare GLP-1 Bridge program eligibility, visit CMS.gov.Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. https://doi.org/10.1007/s13300-024-01554-1. Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152.Based on IQVIA® National Prescription Audit Data, representing 94% of US prescription data as of January 10, 2025.Foundayo. Prescribing Information. Lilly USA, LLC.The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions and modifications) for 72 weeks without initiating prohibited weight management treatments.3The treatment-regimen estimand represents the estimated average treatment effect regardless of adherence to study intervention or initiation of prohibited weight management treatments.3About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLYTrademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.Cautionary Statement Regarding Forward-Looking Statements 
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995), including statements about the supply and access of Zepbound (tirzepatide) as a treatment for adults with obesity or overweight and Foundayo as a treatment for adults with obesity or some adults with overweight who also have weight-related medical problems and reflects Lilly's current belief and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, access, and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that Zepbound will receive additional regulatory approvals, or that Lilly will execute its access and other strategies as planned. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.CMAT-30467 5/2026 ©Lilly USA, LLC 2026. All rights reserved.Refer to:Rachel Sorvig; sorvig_rachel @rose-7507 (Media)  
Michael Czapar; czapar_michael_c @orion-0983 (Investors)   View original content to download multimedia:https://www.prnewswire.com/news-releases/foundayo-and-zepbound-now-covered-for-millions-of-americans-302784360.htmlSOURCE Eli Lilly and Company Original: Foundayo and Zepbound now covered for millions of Americans

Lilly to participate in Goldman Sachs 47th Annual Global Healthcare ConferenceMay 27, 2026 11:15 AM
PR Newswire (US) INDIANAPOLIS, May 27, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) will participate in the Goldman Sachs 47th Annual Global Healthcare Conference on June 9, 2026. Kenneth Custer, executive vice president and president, Lilly Cardiometabolic Health, will take part in a fireside chat at 3:20 p.m. Eastern time.A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly's investor website at https://investor.lilly.com/webcasts-and-presentations. A replay of the presentation will be available on this same website for approximately 90 days.About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. F-LLYTrademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.Refer to: Megan MacCauley; maccauley_megan @Fatcat_2000-1516 (Media)
Michael Czapar; czapar_michael_c @orion-0983 (Investors) View original content to download multimedia:https://www.prnewswire.com/news-releases/lilly-to-participate-in-goldman-sachs-47th-annual-global-healthcare-conference-302783288.htmlSOURCE Eli Lilly and Company Original: Lilly to participate in Goldman Sachs 47th Annual Global Healthcare Conference

Lilly announces three acquisitions to build infectious disease portfolioMay 26, 2026 6:45 AM
PR Newswire (US) Agreements with Curevo, LimmaTech Biologics and Vaccine Company address viral pathogens linked to long-term neurological and oncological risk, and bacterial pathogens that are difficult to prevent or treatAcquisitions build on Lilly's infectious disease legacy and reinforce its commitment to prevention strategies that reduce the long-term burden of serious diseaseINDIANAPOLIS, May 26, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced agreements to acquire three companies, Curevo Inc. (Curevo), LimmaTech Biologics AG (LimmaTech Biologics), and Vaccine Company, Inc. (Vaccine Company), that expand its research and development efforts into infectious disease. The transactions advance Lilly's strategy of investing in differentiated technology platforms to address significant health problems.For 150 years, Lilly has advanced medicines to address the world's most pressing health challenges. Infectious diseases remain a major source of global morbidity, both in their acute presentation and in the downstream health consequences of primary infection.  "These acquisitions reflect a deliberate strategy to prevent disease at its source rather than treat its consequences," said Daniel M. Skovronsky, M.D., Ph.D., chief scientific and product officer, and president, Lilly Research Laboratories. "Decades of evidence now link common infections to diseases that potentially emerge years later, including neurological disease, cancer and infertility. And as antimicrobial resistance erodes our ability to treat bacterial infections, vaccines are increasingly the only path to prevention. Combining these companies' platforms and teams with Lilly's global scale positions us to change that trajectory."Curevo's lead product candidate is amezosvatein, an adjuvanted subunit vaccine for the prevention of shingles in adults. While the current standard of care for shingles prevention is effective, tolerability challenges can limit the overall vaccination rates and contribute to second-dose hesitancy, leaving a meaningful portion of patients with reduced or no protection against shingles and its long-term consequences. Amezosvatein was engineered with a next-generation synthetic adjuvant to overcome this problem. In a Phase 2 clinical trial head-to-head against the standard of care, amezosvatein matched immune response across all primary endpoints and reduced side effects such as activity-limiting fatigue, chills, and pain at the injection site by more than half. Given growing evidence linking shingles to elevated risk of stroke, and that shingles vaccination is associated with reduced dementia risk, a meaningfully better-tolerated vaccine could expand the reach of shingles prevention and reduce these long-term risks at a population level.Under the terms of the agreement, Lilly will acquire Curevo and Curevo shareholders could receive up to $1.5 billion in cash, inclusive of an upfront payment and subsequent payment upon achievement of a specified milestone.LimmaTech Biologics is developing vaccines against bacterial pathogens for which rising antimicrobial resistance is steadily closing therapeutic options, including Staphylococcus aureus, Neisseria gonorrhoeae, and Chlamydia trachomatis. The company's proprietary platform is designed to generate broad, durable immune responses against complex bacterial targets by targeting the toxins and superantigens that drive disease. LimmaTech's lead program, LTB-SA7, is in Phase 1 development as a vaccine against S. aureus, the leading cause of surgical-site infection.  The company's preclinical pipeline is pursuing additional bacterial pathogens, including those that drive infertility and other long-term consequences of infection that fall disproportionately on women. A vaccine-led prevention strategy could change the trajectory of diseases that are becoming increasingly difficult to treat.Under the terms of the agreement, Lilly will acquire LimmaTech for up to $780 million in cash, inclusive of an upfront payment and additional potential payments based upon the achievement of certain clinical and regulatory milestones.Vaccine Company is developing proprietary In Vivo Nanoparticle (IVN) technologies designed to enable the antigen display known to elicit durable immune responses associated with virus-like particle vaccines, while avoiding the manufacturing burden of traditional VLP production. The company is advancing a broad preclinical pipeline spanning multiple viral pathogens; the lead program applies this technology to Epstein-Barr Virus (EBV) with a five-antigen Phase 1-ready candidate. Given the growing evidence linking EBV to multiple sclerosis and several malignancies, a prophylactic vaccine could prevent not only acute infectious mononucleosis but also the long-term neurological and oncological consequences that may follow infection.Under the terms of the agreement, Lilly will acquire Vaccine Company and Vaccine Company shareholders could receive up to $1.55 billion in cash, inclusive of an upfront payment and subsequent payments upon achievement of certain clinical and commercial milestones.These transactions are subject to customary closing conditions, including expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Lilly will determine the accounting treatment of these transactions following closing in accordance with Generally Accepted Accounting Principles (GAAP). These transactions will thereafter be reflected in Lilly's financial results and financial guidance.About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. F-LLYCautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Lilly's proposed acquisitions of Curevo, LimmaTech and Vaccine Company (collectively, the "Companies"), the anticipated benefits of the proposed acquisitions, potential contingent consideration amounts and terms, the applicable parties' ability to satisfy the conditions to the consummation of the proposed acquisitions, each Company's product candidates and ongoing clinical and preclinical development, Lilly's infectious disease business and strategy, expansion of research and development efforts in infectious diseases and potential development of programs, product candidates and medicines to address infectious diseases, and the accounting treatment of the proposed acquisitions under GAAP and their potential impact on Lilly's financial results and financial guidance, and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in closing and implementing the proposed acquisitions and in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that Lilly will close the proposed acquisitions or realize the expected benefits of the proposed acquisitions, that the proposed acquisitions will achieve the results discussed in this release, or that the proposed acquisitions will yield commercially successful products. The Companies' product candidates are investigational and have not been approved by any regulatory authority. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.Refer to:
Ashley Hennessey; gentry_ashley_jo @lmastro-4363 (Media)
Michael Czapar; czapar_michael_c @orion-0983 (Investors) View original content to download multimedia:https://www.prnewswire.com/news-releases/lilly-announces-three-acquisitions-to-build-infectious-disease-portfolio-302781404.htmlSOURCE Eli Lilly and Company Original: Lilly announces three acquisitions to build infectious disease portfolio

A single dose of Lilly's PCSK9 base editor, VERVE-102, reduced PCSK9 by up to 88% and LDL-C by up to 62%, with durable effects supporting its potential as a one-time treatment for hypercholesterolemiaMay 25, 2026 8:45 AM
PR Newswire (US) In the Phase 1b Heart-2 trial, a single intravenous infusion of VERVE-102 produced dose-dependent lowering of PCSK9 and LDL-C, with both reductions sustained over follow-up of up to 18 months in participants at high risk for cardiovascular diseaseVERVE-102 is designed to mimic the protective effect of naturally occurring loss-of-function variants in PCSK9, which are associated with markedly lower lifetime risk of coronary heart diseaseLilly plans to begin enrolling the Phase 2 clinical study of VERVE-102 by the end of this yearINDIANAPOLIS, May 25, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive Phase 1b Heart-2 study results for VERVE-102, an investigational in vivo base editing medicine designed to durably turn off the PCSK9 gene in the liver and lower blood low-density lipoprotein cholesterol (LDL-C) following a single infusion. The Heart-2 trial is evaluating VERVE-102 in adults with heterozygous familial hypercholesterolemia (HeFH) or premature coronary artery disease (CAD). These data were presented as a late-breaking oral presentation at the European Atherosclerosis Society (EAS) Congress and simultaneously published in The New England Journal of Medicine.In the Heart-2 study, a single intravenous infusion of VERVE-102 resulted in meaningful lowering of circulating PCSK9 protein and corresponding reductions in LDL-C across all evaluated dose levels. In this interim analysis of 35 participants, a single dose of VERVE-102 resulted in dose-dependent mean reductions in PCSK9 ranging from 51% to 88%, at the lowest 0.3 mg/kg dose to the highest 1.0 mg/kg dose, respectively. Corresponding mean reductions in LDL-C were 9% (0.3 mg/kg), 44% (0.45 mg/kg), 45% (0.6 mg/kg), 33% (0.7 mg/kg), 51% (0.8 mg/kg), and 62% (1.0 mg/kg). These reductions were sustained over time, with durability observed for up to 18 months following treatment."These early data give us encouraging evidence that in vivo base editing of PCSK9 may offer a novel approach to achieving substantial and durable LDL-C reduction with a one-time treatment," said Riyaz S. Patel, M.D., cardiologist at Barts Health NHS Trust and professor of cardiology at University College London. "Many patients with elevated LDL-C struggle to achieve sustained control despite ongoing efforts with the medicines available today, putting them at significant risk for cardiovascular events. With coronary artery disease still one of the leading causes of death worldwide, the need for new approaches is real."VERVE-102 was well tolerated across all dose levels with no treatment-related serious adverse events (AEs) and no dose-limiting toxicities reported. AEs related to VERVE-102 included low-grade infusion-related reactions and fatigue. All participants received the full planned dose, and no participant withdrew from the study."Twenty years ago, genetics showed us that people born with PCSK9 naturally turned off have low LDL-C for life and are remarkably protected from heart attack, yet today's chronic therapies struggle to deliver this lifelong lowering," said Sekar Kathiresan, M.D., Lilly senior vice president, and co-founder of Verve Therapeutics. "The Heart-2 results provide early clinical evidence that a single dose of VERVE-102 may mimic the LDL-C lowering effects of PCSK9 cardioprotective variants, potentially transforming cardiovascular care from chronic management to a one-time treatment."The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VERVE-102 to reduce LDL-C in participants with hyperlipidemia and high lifetime cardiovascular risk. HeFH affects approximately 1 in 200 to 250 people and is characterized by lifelong elevations in LDL-C, leading to premature cardiovascular disease, including CAD.1,2 Worldwide, CAD remains a leading cause of death, affecting more than 300 million people.3Lilly plans to initiate the Phase 2 clinical study of VERVE-102 by the end of this year.About VERVE-102 and VERVE trial programs
VERVE-102, an investigational in vivo base editing medicine, is designed to be a single-course treatment that turns off the PCSK9 gene in the liver and durably reduces disease-driving LDL-C. VERVE-102 consists of a messenger RNA encoding an adenine base editor and a guide RNA (gRNA) targeting the PCSK9 gene. Both are encapsulated in a lipid nanoparticle (LNP) and administered as a single intravenous infusion over approximately four hours. VERVE-102 uses Verve's proprietary GalNAc-LNP delivery technology, which is designed to allow the LNP to access liver cells using either the low-density lipoprotein receptor (LDLR) or the asialoglycoprotein receptor (ASGPR).In addition to the PCSK9 program, the Pulse-1 Phase 1b trial for VERVE-201, an investigational in vivo gene editing medicine targeting the ANGPTL3 gene, is ongoing.About Heart-2
Heart-2 is an ongoing open-label, single-ascending dose Phase 1b study designed to evaluate the safety, tolerability and pharmacodynamic effects of VERVE-102 in adults with HeFH or premature CAD who require additional lowering of LDL-C, despite maximally tolerated oral lipid lowering therapy. This interim analysis included 35 participants who received a single intravenous infusion of VERVE-102 across six dose cohorts (0.3 mg/kg, 0.45 mg/kg, 0.6 mg/kg, 0.7 mg/kg, 0.8 mg/kg and 1.0 mg/kg). All participants received the full planned dose and were followed for at least 28 days, with a subset now followed for up to 18 months. HeFH is diagnosed based on high LDL-C levels, a personal or family history of atherosclerotic cardiovascular disease, physical exam features and/or mutations identified in certain genes. Premature CAD is defined as evidence of CAD (heart attack, coronary revascularization procedure, or coronary atherosclerosis on imaging) occurring in men 55 years old or younger or women 65 years old or younger. Participants are expected to enroll in a long-term follow-up study for up to 15 years. As of the February 27, 2026, data cut-off, the median follow-up duration was approximately nine months, with 15 participants followed for at least one year.References
1. World Heart Federation. Familial Hypercholesterolemia. Available at: https://world-heart-federation.org/what-we-do/cholesterol/familial-hypercholesterolemia/. Accessed: May 2026.
2. Davletov, K., et al. Prevalence of Familial Hypercholesterolemia and Its Association with Cardiovascular Risk in a Cross-Sectional Adult Population. J Clin Med. 2025 Nov 19;14(22):8213. doi: 10.3390/jcm14228213.
3. Stark, B., et al. Global Prevalence of Coronary Artery Disease: An Update from the Global Burden of Disease Study. ACC. 2024 Apr, 83 (13_Supplement) 2320.About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLYTrademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about VERVE-102 as a potential treatment for people with heterozygous familial hypercholesterolemia (HeFH) or premature coronary artery disease (CAD) and the timeline for future readouts, presentations, and other milestones relating to VERVE-102 and its clinical trials, and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that VERVE-102 will prove to be a safe and effective treatment for people with HeFH or premature CAD, that VERVE-102 will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.Refer to:Marisa Miller; marisa.miller @trader_tex-2833 (Media)
Michael Czapar; czapar_michael_c @orion-0983 (Investors)  View original content to download multimedia:https://www.prnewswire.com/news-releases/a-single-dose-of-lillys-pcsk9-base-editor-verve-102-reduced-pcsk9-by-up-to-88-and-ldl-c-by-up-to-62-with-durable-effects-supporting-its-potential-as-a-one-time-treatment-for-hypercholesterolemia-302780172.htmlSOURCE Eli Lilly and Company Original: A single dose of Lilly's PCSK9 base editor, VERVE-102, reduced PCSK9 by up to 88% and LDL-C by up to 62%, with durable effects supporting its potential as a one-time treatment for hypercholesterolemia

Lilly to showcase oncology portfolio across tumor types and treatment modalities at the 2026 American Society of Clinical Oncology Annual MeetingMay 21, 2026 5:00 PM
PR Newswire (US) Phase 3 LIBRETTO-432 study evaluating Retevmo (selpercatinib) as adjuvant therapy in RET fusion-positive NSCLC to be featured in the Plenary Session and ASCO press program Investigator-initiated study of Verzenio (abemaciclib) in patients with advanced dedifferentiated liposarcoma also selected for the Plenary SessionKelonia Therapeutics, which Lilly has agreed to acquire, will present updated data for its BCMA-targeted in vivo CAR-T therapy in patients with relapsed and refractory multiple myeloma Additional Lilly presentations include the first clinical results for an investigational ADC targeting Nectin-4 in patients with advanced urothelial carcinoma and data from programs across lung, breast and blood cancers  INDIANAPOLIS, May 21, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the details of presentations from across its oncology portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 - June 2 in Chicago, Illinois.Data at ASCO include two Plenary Session presentations, featuring primary event-free survival results from the Phase 3 LIBRETTO-432 study of adjuvant Retevmo (selpercatinib) in rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) and an investigator-initiated Phase 3 study, SARC041, evaluating Verzenio (abemaciclib) in patients with advanced dedifferentiated liposarcoma. Additional data include an oral presentation of initial results of an investigational antibody drug conjugate (ADC) targeting Nectin-4 in patients with advanced or metastatic urothelial carcinoma, and data from programs in lung, breast and blood cancers. Updated data from Kelonia Therapeutics' Phase 1 inMMyCAR study of an anti-B-cell maturation antigen (BCMA) targeted in vivo CAR-T therapy in patients with relapsed and refractory multiple myeloma will also be presented in an oral session. Lilly's proposed acquisition of Kelonia Therapeutics was previously announced and is pending transaction close."We continue to grow the breadth and depth of the Lilly Oncology portfolio, with clinical programs in nearly every subspeciality of oncology, utilizing a diverse array of technologies to address patients' disease," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "Our presence at this year's ASCO reflects a snapshot of our most recent meaningful advances, including data for both Retevmo and Verzenio that will be presented in the Plenary Session. These data are complemented by initial proof of concept results for our next antibody drug conjugate and new data from the Kelonia in vivo CAR-T program. Collectively, these findings reflect the expanding reach of our pipeline and our commitment to delivering in ways that matter for patients."Lilly Presentation Highlights: Retevmo (selpercatinib; RET kinase inhibitor): In a late-breaking presentation in the Plenary Session, Lilly will share primary event-free survival results from the Phase 3 LIBRETTO-432 study of adjuvant selpercatinib in patients with stage IB-IIIA RET fusion-positive NSCLC. Lilly previously announced that selpercatinib met the primary endpoint, demonstrating a highly significant and clinically meaningful improvement in investigator-assessed event free survival. These results were also selected to be highlighted in the ASCO Annual Meeting press program session on May 30.Verzenio (abemaciclib; CDK4/6 Inhibitor): In a Plenary Session presentation, results will be shared from the Phase 3 investigator-initiated SARC041 study, evaluating abemaciclib in patients with advanced dedifferentiated liposarcoma.LY4052031 (investigational ADC targeting Nectin-4): In an oral presentation, initial results will be shared from the Phase 1 NEXUS-01 study evaluating LY4052031, an ADC targeting Nectin-4, in patients with advanced or metastatic urothelial carcinoma.Kelonia Therapeutics Presentation: KLN-1010 (investigational in vivo CAR-T therapy): In a rapid oral presentation, updated results will be shared from the Phase 1 inMMyCAR study of KLN-1010 in patients with relapsed and refractory multiple myeloma.A full list of abstract titles and viewing details are listed below:Abstract TitleAuthorPresentation
Type/#Session TitleSession
Date/Time
(CDT)Retevmo (selpercatinib; RET kinase inhibitor)Event-free survival with
adjuvant selpercatinib in Stage IB-
IIIA RET fusion-positive NSCLC: Primary
results of the Phase 3 LIBRETTO-432 trial Jonathan
GoldmanOral
Presentation
(LBA3)Plenary SessionSession Date:
Sunday, May 31Presentation
Time: 1:00 p.m.
– 4:00 p.m. LY4052031 (investigational ADC targeting Nectin-4)Initial results from NEXUS-01, a Phase 1
study of LY4052031, an antibody-drug
conjugate targeting Nectin-4, in
participants with advanced or metastatic
urothelial carcinomaGopa IyerOral
Presentation
#4508Genitourinary
Cancer—Kidney and
BladderSession Date:
Friday, May 29Presentation
Time: 2:45 p.m.
– 5:45 p.m. LY4101174 (investigational ADC targeting Nectin-4)Initial results from EXCEED, a Phase 1
study of LY4101174, an antibody-drug
conjugate targeting Nectin-4, in
participants with advanced or metastatic
urothelial carcinoma Xin GaoRapid Oral
Presentation
#4517Genitourinary
Cancer—Kidney and
BladderSession Date:
Monday, June 1Presentation
Time: 8:00 a.m.
– 9:30 a.m. Verzenio (abemaciclib; CDK4/6 inhibitor) [Investigator-Initiated]SARC041: A Phase 3 randomized double-
blind study of abemaciclib versus placebo
in patients with advanced
dedifferentiated liposarcomaMark 
DicksonOral
PresentationPlenary SessionSession Date:
Sunday, May 31Presentation
Time: 1:00 p.m.
– 4:00 p.m. Olomorasib (investigational KRAS G12C inhibitor)First-line (1L) olomorasib +
pembrolizumab in patients with KRAS
G12C-mutant advanced NSCLC, and PD-L1
expression 0-49%, from the dose
optimization cohorts of LOXO-RAS-20001
and SUNRAY-01Bryan A.
ChanPoster Board
#418Lung Cancer—Non-Small Cell
MetastaticSession Date:
Sunday, May 31Presentation
Time: 9:00 a.m.
– 12:00 p.m. 1L olomorasib plus pembrolizumab +/-
chemotherapy in KRAS G12C-Mutant
NSCLC patients +/- a prior cycle of SOC:
Results from LOXO-RAS 20001 and SUNRAY-01Timothy
BurnsPoster Board
#360Lung Cancer—Non-Small Cell
MetastaticSession Date:
Sunday, May 31Presentation
Time: 9:00 a.m.
– 12:00 p.m. Jaypirca (pirtobrutinib; non-covalent BTK inhibitor)Pirtobrutinib in treatment-naïve patients
with CLL/SLL: Pooled results from BRUIN
CLL-313 and BRUIN CLL-314William G.
WierdaPoster Board #542Hematologic
Malignancies—Lymphoma and
Chronic Lymphocytic
LeukemiaSession Date:
Monday, June 1 Presentation
Time: 9:00 a.m.
– 12:00 p.m. Tersolisib (investigational pan-mutant selective PI3Ka inhibitor)A Phase 1/2 trial of tersolisib
(LY4064809/STX-478), a pan-mutant-
selective PI3Ka inhibitor (PI3Kai), in
PIK3CA-mutant advanced solid tumors:
Updated results from PIKALO-1Komal
JhaveriPoster Board
#186Breast Cancer—
MetastaticSession Date:
Monday, June 1Presentation
Time: 1:30 p.m.
– 4:30 p.m. KLN-1010 (Kelonia Therapeutics' investigational in vivo CAR-T therapy) Updated results from inMMyCAR, the
ongoing first-in-human Phase 1 study of
KLN-1010 in patients with relapsed and
refractory multiple myeloma (RRMM)Phoebe Joy
HoRapid Oral
Presentation
#7509 Hematologic
Malignancies—
Plasma Cell DyscrasiaSession Date:
Sunday, May 31Presentation
Time: 9:45 a.m.
– 11:15 a.m.For more information on Lilly's oncology pipeline click here.*Lilly and Kelonia Therapeutics, Inc. remain two separate, independent companies prior to closing. The transaction is subject to customary closing conditions, including customary regulatory approvals, and is expected to close in the second half of 2026.About Retevmo
Retevmo (selpercatinib, formerly known as LOXO-292) (pronounced reh-TEHV-moh) is a highly selective and potent RET kinase inhibitor with central nervous system (CNS) activity. Retevmo may affect both tumor cells and healthy cells, which can result in side effects. RET-driver alterations are predominantly mutually exclusive from other oncogenic drivers. Retevmo is a U.S. FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (500 ms was measured in 7% of patients and an increase in the QTcF interval of at least 60 ms over baseline was measured in 20% of patients. Retevmo has not been studied in patients with clinically significant active cardiovascular disease or recent myocardial infarction. Monitor patients who are at significant risk of developing QTc prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, and severe or uncontrolled heart failure. Assess QT interval, electrolytes, and thyroid-stimulating hormone (TSH) at baseline and periodically during treatment, adjusting frequency based upon risk factors including diarrhea. Correct hypokalemia, hypomagnesemia, and hypocalcemia prior to initiating Retevmo and during treatment. Monitor the QT interval more frequently when Retevmo is concomitantly administered with strong and moderate CYP3A inhibitors or drugs known to prolong QTc interval. Withhold and dose reduce or permanently discontinue Retevmo based on the severity.Serious, including fatal, hemorrhagic events can occur with Retevmo. Grade ≥3 hemorrhagic events occurred in 3.1% of patients treated with Retevmo including 4 (0.5%) patients with fatal hemorrhagic events, including cerebral hemorrhage (n=2), tracheostomy site hemorrhage (n=1), and hemoptysis (n=1). Permanently discontinue Retevmo in patients with severe or life-threatening hemorrhage.Retevmo can cause hypersensitivity, including severe skin reactions such as Stevens-Johnson Syndrome. All grade hypersensitivity occurred in 6% of patients receiving Retevmo, including Grade 3 in 1.9%. The median time to onset was 1.9 weeks (range: 5 days to 2 years). Signs and symptoms of hypersensitivity included fever, rash and arthralgias or myalgias with concurrent decreased platelets or transaminitis. Stevens-Johnson Syndrome has been observed in the post-marketing setting. Discontinue Retevmo in patients with Stevens-Johnson Syndrome. If hypersensitivity occurs, withhold Retevmo and begin corticosteroids at a dose of 1 mg/kg prednisone (or equivalent). Upon resolution of the event, resume Retevmo at a reduced dose and increase the dose of Retevmo by 1 dose level each week as tolerated until reaching the dose taken prior to onset of hypersensitivity. Continue steroids until patient reaches target dose and then taper. Permanently discontinue Retevmo for recurrent hypersensitivity.Tumor lysis syndrome (TLS) occurred in 0.6% of patients with medullary thyroid carcinoma receiving Retevmo. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated.Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, Retevmo has the potential to adversely affect wound healing. Withhold Retevmo for at least 7 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of Retevmo after resolution of wound healing complications has not been established.Retevmo can cause hypothyroidism. Hypothyroidism occurred in 13% of patients treated with Retevmo; all reactions were Grade 1 or 2. Hypothyroidism occurred in 13% of patients (50/373) with thyroid cancer and 13% of patients (53/423) with other solid tumors including NSCLC. Monitor thyroid function before treatment with Retevmo and periodically during treatment. Treat with thyroid hormone replacement as clinically indicated. Withhold Retevmo until clinically stable or permanently discontinue Retevmo based on severity.Based on data from animal reproduction studies and its mechanism of action, Retevmo can cause fetal harm when administered to a pregnant woman. Administration of selpercatinib to pregnant rats during organogenesis at maternal exposures that were approximately equal to those observed at the recommended human dose of 160 mg twice daily resulted in embryolethality and malformations. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Retevmo and for 1 week after the last dose. There are no data on the presence of selpercatinib or its metabolites in human milk or on their effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with Retevmo and for 1 week after the last dose.Severe adverse reactions (Grade 3-4) occurring in ≥20% of patients who received Retevmo in LIBRETTO-001, were hypertension (20%), diarrhea (5%), prolonged QT interval (4.8%), dyspnea (3.1%), fatigue (3.1%), hemorrhage (2.6%), abdominal pain (2.5%), vomiting (1.8%), headache (1.4%), nausea (1.1%), constipation (0.8%), edema (0.8%), rash (0.6%), and arthralgia (0.3%).Severe adverse reactions (Grade 3-4) occurring in ≥15% of patients who received Retevmo or chemotherapy with or without pembrolizumab in LIBRETTO-431 were hypertension (20% vs 3.1%), electrocardiogram QT prolonged (9% vs 0%), fatigue (3.2% vs 5%), edema (2.5% vs 0%), rash (1.9% vs 1.0%), diarrhea (1.3% vs 2.0%), abdominal pain (0.6% vs 2.0%), pyrexia (0.6% vs 0%), COVID19 infection (0.6% vs 0%), constipation (0% vs 1.0%), nausea (0% vs 1.0%), vomiting (0% vs 1.0%), and decreased appetite (0% vs 2.0%).Serious adverse reactions occurred in 44% of patients who received Retevmo in LIBRETTO-001. The most frequently reported serious adverse reactions (in ≥2% of patients) were pneumonia, pleural effusion, abdominal pain, hemorrhage, hypersensitivity, dyspnea, and hyponatremia. Fatal adverse reactions occurred in 3% of patients in LIBRETTO-001; fatal adverse reactions included sepsis (n=6), respiratory failure (n=5), hemorrhage (n=4), pneumonia (n=3), pneumonitis (n=2), cardiac arrest (n=2), sudden death (n=1), and cardiac failure (n=1).Serious adverse reactions occurred in 35% of patients who received Retevmo in LIBRETTO-431. The most frequently reported serious adverse reactions (≥2% of patients) were pleural effusion and abnormal hepatic function. Fatal adverse reactions occurred in 4.4% of patients who received Retevmo in LIBRETTO-431; fatal adverse reactions included myocardial infarction (n=2), respiratory failure (n=2), cardiac arrest, malnutrition, and sudden death (n=1 each).Common adverse reactions (all grades) occurring in ≥20% of patients who received Retevmo in LIBRETTO-001, were edema (49%), diarrhea (47%), fatigue (46%), dry mouth (43%), hypertension (41%), abdominal pain (34%), rash (33%), constipation (33%), nausea (31%), headache (28%), cough (24%), vomiting (22%), dyspnea (22%), hemorrhage (22%), arthralgia (21%), and prolonged QT interval (21%).Common adverse reactions (all grades) occurring in ≥15% of patients who received Retevmo or chemotherapy with or without pembrolizumab in LIBRETTO-431 were hypertension (48% vs 7%), diarrhea (44% vs 24%), edema (41% vs 28%), dry mouth (39% vs 6%), rash (33% vs 30%), fatigue (32% vs 50%), abdominal pain (25% vs 19%), musculoskeletal pain (25% vs 28%), constipation (22% vs 40%), electrocardiogram QT prolonged (20% vs 1.0%), COVID19 infection (19% vs 18%), stomatitis (18% vs 16%), decreased appetite (17% vs 34%), nausea (13% vs 44%), vomiting (13% vs 23%), and pyrexia (13% vs 23%).Laboratory abnormalities (all grades ≥20%; Grade 3-4) worsening from baseline in patients who received Retevmo in LIBRETTO-001, were increased AST (59%; 11%), decreased calcium (59%; 5.7%), increased ALT (56%; 12%), decreased albumin (56%; 2.3%), increased glucose (53%; 2.8%), decreased lymphocytes (52%; 20%), increased creatinine (47%; 2.4%), decreased sodium (42%; 11%), increased alkaline phosphatase (40%; 3.4%), decreased platelets (37%; 3.2%), increased total cholesterol (35%; 1.7%), increased potassium (34%; 2.7%), decreased glucose (34%; 1.0%), decreased magnesium (33%; 0.6%), increased bilirubin (30%; 2.8%), decreased hemoglobin (28%; 3.5%), and decreased neutrophils (25%; 3.2%).Laboratory abnormalities (all grades ≥20%; Grade 3-4) worsening from baseline in patients who received Retevmo or chemotherapy with or without pembrolizumab in LIBRETTO-431 were increased ALT (81%; 21% vs 63%; 4.1%), increased AST (77%; 10% vs 46%; 0%), decreased calcium (53%; 1.9% vs 24%; 1.0%), decreased platelets (53%; 3.2% vs 39%; 5%), decreased lymphocytes (53%; 8% vs 64%; 15%), decreased neutrophils (53%; 2.0% vs 58%; 11%), increased bilirubin (52%; 1.3% vs 9%; 0%), increased alkaline phosphatase (35%; 1.3% vs 22%; 0%), decreased sodium (31%; 3.2% vs 41%; 2.1%), decreased albumin (25%; 0% vs 5%; 0%), increased blood creatinine (23%; 0% vs 21%; 0%), decreased hemoglobin (21%; 0% vs 91%; 5%), decreased potassium (17%; 1.3% vs 15%; 1.0%), and decreased magnesium (16%; 0.6% vs 8%; 0%).Concomitant use of acid-reducing agents decreases selpercatinib plasma concentrations which may reduce Retevmo anti-tumor activity. Avoid concomitant use of proton-pump inhibitors (PPIs), histamine-2 (H2) receptor antagonists, and locally acting antacids with Retevmo. If coadministration cannot be avoided, take Retevmo with food (with a PPI) or modify its administration time (with a H2 receptor antagonist or a locally acting antacid).Concomitant use of strong and moderate CYP3A inhibitors increases selpercatinib plasma concentrations which may increase the risk of Retevmo adverse reactions including QTc interval prolongation. Avoid concomitant use of strong and moderate CYP3A inhibitors with Retevmo. If concomitant use of a strong or moderate CYP3A inhibitor cannot be avoided, reduce the Retevmo dosage as recommended and monitor the QT interval with ECGs more frequently.Concomitant use of strong and moderate CYP3A inducers decreases selpercatinib plasma concentrations which may reduce Retevmo anti-tumor activity. Avoid coadministration of Retevmo with strong and moderate CYP3A inducers.Concomitant use of Retevmo with CYP2C8 and CYP3A substrates increases their plasma concentrations which may increase the risk of adverse reactions related to these substrates. Avoid coadministration of Retevmo with CYP2C8 and CYP3A substrates where minimal concentration changes may lead to increased adverse reactions. If coadministration cannot be avoided, follow recommendations for CYP2C8 and CYP3A substrates provided in their approved product labeling.Retevmo is a P-glycoprotein (P-gp) and BCRP inhibitor. Concomitant use of Retevmo with P-gp or BCRP substrates increases their plasma concentrations, which may increase the risk of adverse reactions related to these substrates. Avoid coadministration of Retevmo with P-gp or BCRP substrates where minimal concentration changes may lead to increased adverse reactions. If coadministration cannot be avoided, follow recommendations for P-gp and BCRP substrates provided in their approved product labeling.No dosage modification is recommended for patients with mild to severe renal impairment (estimated Glomerular Filtration Rate [eGFR] ≥15 to 89 mL/min, estimated by Modification of Diet in Renal Disease [MDRD] equation). A recommended dosage has not been established for patients with end-stage renal disease.Reduce the dose when administering Retevmo to patients with severe hepatic impairment (total bilirubin greater than 3 to 10 times upper limit of normal [ULN] and any AST). No dosage modification is recommended for patients with mild or moderate hepatic impairment. Monitor for Retevmo-related adverse reactions in patients with hepatic impairment.Retevmo (selpercatinib) is available as 40 mg and 80 mg capsules, and 40 mg, 80 mg, 120 mg, and 160 mg tablets.SE HCP ISI LA_NOV2025Please see full Prescribing Information, including Instructions for Use, for Retevmo.About LY4052031
LY4052031 is an investigational, next-generation anti-Nectin-4 antibody-drug conjugate (ADC) targeting Nectin-4, a protein overexpressed in several solid tumor types including urothelial, breast, cervix, lung, and ovarian cancers.2 LY4052031 is composed of a fully human IgG1 Fc-silent monoclonal antibody linked to a novel camptothecin (topoisomerase I inhibitor) payload via a cleavable linker with a homogeneous drug-antibody ratio (DAR) of 8:1, and has demonstrated antitumor activity across a range of Nectin-4 expression levels in preclinical models, including in a Nectin-4 MMAE ADC-resistant model.2,3 LY4052031 is currently being studied in a global, open-label, multicenter, Phase 1a/1b study in patients with advanced or metastatic urothelial carcinoma and other select solid tumors, NCT06465069.About LY4101174
LY4101174 is an investigational, next-generation anti-Nectin-4 antibody-drug conjugate (ADC) targeting Nectin-4, a protein overexpressed in several solid tumor types including urothelial, breast, cervix, lung, and ovarian cancers.2 LY4101174 is comprised of a humanized IgG1 Fc-silent monoclonal antibody linked to the topoisomerase I inhibitor exatecan via a polysarcosine linker with a homogeneous drug-antibody ratio (DAR) of 8:1, and has demonstrated antitumor activity across a range of Nectin-4 expression levels in preclinical models, including in a Nectin-4 MMAE ADC-resistant model.2,3 LY4101174 is currently being studied in a global, open-label, multicenter, Phase 1a/1b study in patients with advanced or metastatic urothelial carcinoma and select solid tumors, NCT06238479.About Verzenio (abemaciclib)
Verzenio (abemaciclib) is approved to treat people with certain HR+, HER2- breast cancers in the adjuvant and advanced or metastatic setting. Verzenio is the first CDK4/6 inhibitor approved to treat node-positive, high-risk early breast cancer (EBC) patients.4 For HR+, HER2- breast cancer, The National Comprehensive Cancer Network® (NCCN®) recommends consideration of two years of abemaciclib (Verzenio) added to endocrine therapy as a Category 1 treatment option in the adjuvant setting.5 NCCN® also includes Verzenio plus endocrine therapy as a preferred treatment option for HR+, HER2- metastatic breast cancer.5The collective results of Lilly's clinical development program continue to differentiate Verzenio as a CDK4/6 inhibitor. In high-risk EBC, Verzenio has shown a persistent and deepening benefit beyond the two-year treatment period in the monarchE trial, an adjuvant study designed specifically to investigate a CDK4/6 inhibitor in a node-positive, high-risk EBC population.6 In metastatic breast cancer, Verzenio has demonstrated statistically significant OS in the Phase 3 MONARCH 2 study.7 Verzenio has shown a consistent and generally manageable safety profile across clinical trials.Verzenio is an oral tablet taken twice daily and available in strengths of 50 mg, 100 mg, 150 mg, and 200 mg. Discovered and developed by Lilly researchers, Verzenio was first approved in 2017 and is currently authorized for use in more than 90 countries around the world. For full details on indicated uses of Verzenio in HR+, HER2- breast cancer, please see full Prescribing Information, available at www.Verzenio.com.INDICATIONS FOR VERZENIO
VERZENIO is a kinase inhibitor indicated:in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.IMPORTANT SAFETY INFORMATION FOR VERZENIO (abemaciclib)
Severe diarrhea associated with dehydration and infection occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, diarrhea occurred in 81 to 90% of patients who received Verzenio. Grade 3 diarrhea occurred in 8 to 20% of patients receiving Verzenio. Most patients experienced diarrhea during the first month of Verzenio treatment. The median time to onset of the first diarrhea event ranged from 6 to 8 days; and the median duration of Grade 2 and Grade 3 diarrhea ranged from 6 to 11 days and 5 to 8 days, respectively. Across trials, 19 to 26% of patients with diarrhea required a Verzenio dose interruption and 13 to 23% required a dose reduction.Instruct patients to start antidiarrheal therapy, such as loperamide, at the first sign of loose stools, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow-up. For Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization, discontinue Verzenio until toxicity resolves to ≤Grade 1, and then resume Verzenio at the next lower dose.Neutropenia, including febrile neutropenia and fatal neutropenic sepsis, occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, neutropenia occurred in 37 to 46% of patients receiving Verzenio. A Grade ≥3 decrease in neutrophil count (based on laboratory findings) occurred in 19 to 32% of patients receiving Verzenio. Across trials, the median time to first episode of Grade ≥3 neutropenia ranged from 29 to 33 days, and the median duration of Grade ≥3 neutropenia ranged from 11 to 16 days. Febrile neutropenia has been reported in

Eli Lilly shares rise after strong late-stage obesity drug trial results (LLY)May 21, 2026 8:49 AM
IH Market News Eli Lilly (NYSE:LLY) shares gained around 2% in premarket trading on Thursday after the company released positive late-stage clinical trial results for its experimental obesity treatment retatrutide.The study showed that patients diagnosed with obesity lost an average of 28.3% of their body weight over an 80-week period when treated with the highest 12-milligram dose of retatrutide.More than 45% of participants achieved weight loss of at least 30% during the trial.The results strengthen Eli Lilly’s path toward seeking regulatory approval for the drug, with a potential commercial launch possible next year.The study focused on patients with obesity who did not have diabetes.Retatrutide is the first obesity treatment developed by Lilly that targets three separate hormone receptors simultaneously: GLP-1, which helps suppress appetite; GIP, which supports insulin secretion; and glucagon, which assists with fat burning.Earlier clinical studies suggested the drug could deliver greater weight reduction than Lilly’s injectable obesity medication Zepbound as well as Novo Nordisk’s (NYSE:NVO) Wegovy.The late-stage trial enrolled adults living with obesity or individuals classified as overweight who also had at least one weight-related health condition.Kenneth Custer, president of cardiometabolic health at Eli Lilly, said the 30% weight-loss benchmark “is really a threshold that’s historically been associated with bariatric surgery. To have that available in a medicine is a pretty big deal.”The latest results mark another significant step in Eli Lilly’s efforts to strengthen its position within the rapidly expanding obesity drug market.Eli Lilly stock priceNovo Nordisk stock price Original: Eli Lilly shares rise after strong late-stage obesity drug trial results (LLY)

Lilly's triple agonist, retatrutide, delivered powerful weight loss in pivotal Phase 3 obesity trialMay 21, 2026 6:45 AM
PR Newswire (US)  In TRIUMPH-1, participants on 12 mg retatrutide lost an average of 70.3 lbs (28.3%) over 80 weeks with 45.3% of participants achieving ≥30% weight loss, a level long associated with bariatric surgery Individuals with a baseline BMI ≥35 who participated in a study extension continued to lose weight, and achieved up to an average of 85.0 lbs (30.3%) weight loss at 104 weeks At the 4 mg dose, reached with only a single escalation step, participants lost an average of 47.2 lbs (19.0%) at 80 weeks with a lower observed discontinuation rate due to adverse events vs. placeboINDIANAPOLIS, May 21, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY), the maker of Zepbound (tirzepatide) and Foundayo (orforglipron), today announced positive topline results from TRIUMPH-1, a Phase 3 clinical trial evaluating the efficacy and safety of retatrutide, an investigational, first-in-class GIP, GLP-1, and glucagon triple hormone receptor agonist, in adults with obesity or overweight and at least one weight-related comorbidity and without diabetes. At 80 weeks, all doses of retatrutide (4 mg, 9 mg, and 12 mg) met the primary and key secondary endpoints for obesity, delivering clinically meaningful weight loss."Obesity is a chronic disease, and people living with obesity deserve treatment options that match the complex biology of their neurometabolic disease," said Ania Jastreboff, M.D., Ph.D., Professor of Medicine & Pediatrics (Endocrinology) at the Yale School of Medicine, Director of the Yale Obesity Research Center (Y-Weight), and lead investigator. "It was impressive to see that every dose of retatrutide resulted in clinically meaningful weight reduction for nearly all participants, and people with severe obesity on the highest dose lost on average 30% of their body weight over two years. Importantly, treatment with retatrutide not only resulted in robust weight reduction, but also in clear improvements in assessed cardiometabolic health measures. For patients I see in clinic, retatrutide may potentially be a highly impactful future tool to treat their obesity and transform their health trajectory."For the primary endpoint, participants taking retatrutide 9 mg and 12 mg lost an average of 64.4 lbs (25.9%) and 70.3 lbs (28.3%), respectively. Those taking the 4 mg dose of retatrutide, with just a single dose escalation step, lost an average of 47.2 lbs (19.0%). Notably, 65.3% of participants taking retatrutide 12 mg achieved a BMI

Lilly to participate in Bernstein's 42nd Annual Strategic Decisions ConferenceMay 18, 2026 10:00 AM
PR Newswire (US) INDIANAPOLIS, May 18, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) will participate in Bernstein's 42nd Annual Strategic Decisions Conference on May 28, 2026. Daniel M. Skovronsky, M.D., Ph.D., chief scientific and product officer, and president of Lilly Research Laboratories, will take part in a fireside chat at 1:30 p.m., Eastern time.A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly's investor website at https://investor.lilly.com/webcasts-and-presentations. A replay of the presentation will be available on this same website for approximately 90 days.About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. F-LLYTrademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.Refer to:Ashley Hennessey; gentry_ashley_jo @lmastro-4363 (Media)
Michael Czapar; czapar_michael_c @orion-0983 (Investors) View original content to download multimedia:https://www.prnewswire.com/news-releases/lilly-to-participate-in-bernsteins-42nd-annual-strategic-decisions-conference-302774752.htmlSOURCE Eli Lilly and Company Original: Lilly to participate in Bernstein's 42nd Annual Strategic Decisions Conference

Lilly, Caitlin Clark Foundation, and Musco Lighting open three community sports courts in Indianapolis, expanding year-round access for youthMay 16, 2026 11:00 AM
PR Newswire (US) Lilly to provide park and court to the City of Indianapolis as part of its 150th anniversary celebrationINDIANAPOLIS, May 16, 2026 /PRNewswire/ -- The Caitlin Clark Foundation, in partnership with Eli Lilly and Company (NYSE: LLY) and Musco Lighting, has opened three new multi-sport community courts across Indianapolis—creating year-round access to safe, high-quality spaces for youth to play. These latest court openings include two courts at Indianapolis Public Schools—Clarence Farrington and Edison School of the Arts—and a public court at the corner of E. South Street and S. New Jersey Street, that Lilly will provide to the City of Indianapolis and Indy Parks as part of its 150th anniversary celebration.Caitlin Clark, founder of the Foundation and advocate for youth access to sport, has been closely involved in the vision behind Community Courts and its expansion into Indianapolis. "I grew up playing a lot of different sports, and some of my favorite memories are just being outside with my friends and brothers, competing and having fun," said Caitlin Clark. "That's where so much growth happens. These courts give kids in Indianapolis a place to do that every day, and I'm thankful to Lilly and Musco for helping make it possible.""Caitlin has always believed in the power of sport to shape confidence, discipline, and opportunity," said Mary Coffin, President of the Caitlin Clark Foundation. "These courts give more young people a place to build those foundations together in their communities."As part of its 150th anniversary, Lilly is providing the park and court at the corner of E. South Street and S. New Jersey Street to the City of Indianapolis and Indy Parks, reinforcing its longstanding connection to the community and commitment to investing in spaces where people live, play and gather."Health is shaped not only by medicine, but by the spaces and opportunities that help people stay active and connected," said Melissa Coe, Associate Vice President, Social Impact & Community Engagement at Lilly. "Through our partnership with the Caitlin Clark Foundation, we're proud to help create places across Indianapolis where young people and families can come together, move and build healthy habits that last.""Indy Parks is deeply grateful for the generosity of Lilly and the Caitlin Clark Foundation," said Indy Parks Director Brittany Crone. "The new park will be a vibrant and inspiring spot that encourages us to slow down and play together right in the heart of our downtown." The court at the corner of E. South Street and S. New Jersey Street will remain open to the public as a free, accessible space maintained by Indy Parks and Recreation, while the IPS courts will support students through school programming—ensuring these spaces serve as lasting resources for the community. Built using the Musco Mini-Pitch System™, the courts are designed for basketball, soccer, and futsal, and include lighting, and ADA-accessible features—creating flexible, inclusive spaces for a wide range of users."Every kid and every family deserves a place where they can connect with their community—and that's exactly what these community courts are bringing to Indianapolis," said Jeff Rogers, CEO of Musco. "We commend our partners at the Caitlin Clark Foundation and at Lilly. This is going to impact a lot of lives for many years."About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. C-LLY
 About Caitlin Clark Foundation
The Caitlin Clark Foundation is dedicated to uplifting and improving the lives of youth and their communities through education, nutrition, and sport—the pillars that shaped Caitlin's own journey. Through initiatives like Community Courts, the Foundation creates opportunities for young people to grow, compete, and thrive. Learn more at www.caitlinclarkfoundation.org.About Musco Lighting
For 50 years, Musco has been the world leader in sports lighting and facility solutions, providing innovative solutions for projects in more than 135 countries. Musco Lighting solutions are found on neighborhood fields, major stadiums and arenas, international airports, rail yards, the Olympic Games, iconic landmarks, and some of the world's largest ports. Musco has installed over 450 mini-pitches in the U.S. and is collaborating with the U.S. Soccer Foundation to bring 1,000 mini-pitches to the U.S. by the 2026 FIFA World Cup. For more information, visit www.musco.com/mini-pitch/.Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.Refer to:Jessica Thompson; thompson_jessica @stockmama-2042 (Lilly)
Mary Coffin; mary.coffin@caitlinclarkfoundation.org (Caitlin Clark Foundation)  View original content to download multimedia:https://www.prnewswire.com/news-releases/lilly-caitlin-clark-foundation-and-musco-lighting-open-three-community-sports-courts-in-indianapolis-expanding-year-round-access-for-youth-302774000.htmlSOURCE Eli Lilly and Company Original: Lilly, Caitlin Clark Foundation, and Musco Lighting open three community sports courts in Indianapolis, expanding year-round access for youth

Lilly's Foundayo and lower-dose Zepbound helped people maintain weight loss after switching from higher doses of injectable incretin therapy in two late-phase trialsMay 12, 2026 6:01 PM
PR Newswire (US) In ATTAIN-MAINTAIN, participants who transitioned from a maximum tolerated dose (MTD) of Wegovy (semaglutide) to Foundayo maintained all but 0.9 kg of their previously achieved weight loss on average after one yearIn ATTAIN-MAINTAIN and SURMOUNT-MAINTAIN, participants who switched from Zepbound MTD to Foundayo or reduced the dose of Zepbound to 5 mg, respectively, maintained all but 5.0 kg and 5.6 kg of their previous weight loss on average after one yearParticipants in SURMOUNT-MAINTAIN who remained on Zepbound MTD for an additional year maintained all of their prior weight loss on averageINDIANAPOLIS, May 12, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from two late-phase trials showing that people with obesity maintained their weight loss long term with either Foundayo or lower-dose Zepbound after switching from higher doses of injectable incretin therapy. The findings from SURMOUNT-MAINTAIN and ATTAIN-MAINTAIN, were presented at the 33rd European Congress on Obesity (ECO) and published in The Lancet and Nature Medicine, respectively."Weight regain remains one of the biggest challenges in obesity care, and is often the result of treatment interruptions that cause biology to work against patients, undoing the progress they've made," said Louis J. Aronne, M.D., FACP, DABOM, founder and Chair Emeritus of the American Board of Obesity Medicine, former president of The Obesity Society, Fellow of the American College of Physicians, world-renowned obesity specialist and Lilly consultant. "These medicines can be used for long-term maintenance today, and results from SURMOUNT-MAINTAIN and ATTAIN-MAINTAIN provide additional evidence of their potential when switching from higher doses of injectable incretin therapy."In SURMOUNT-MAINTAIN, both Zepbound MTD and Zepbound 5 mg met the primary and all key secondary endpoints, demonstrating weight-loss maintenance after 60-weeks of initial treatment with Zepbound MTD.1,2 The primary endpoint was to demonstrate that continuation of Zepbound either at a reduced 5 mg dose or at MTD was superior to placebo in percent change in body weight at week 112. At week 112, participants continuing treatment with Zepbound MTD preserved all of their prior weight loss, while dose reduction to 5 mg maintained all but 5.6 kg on average.SURMOUNT-MAINTAIN Weight Maintenance Results
Zepbound MTD to Zepbound MTDZepbound MTD to Zepbound 5 mg Avg. starting body weighti 112.2 kg (247.4 lbs) 113.4 kg (250.0 lbs) Avg. body weight after 60 weeks of Zepbound MTDii,iii 89.5 kg (197.3 lbs) 89.0 kg (196.2 lbs) Avg. body weight at 52 weeks of maintenanceii 88.7 kg (195.6 lbs) 94.6 kg (208.6 lbs) iObserved mean based on efficacy estimand data set. iiMixed Model for Repeated Measures (MMRM) based on efficacy estimand data set.iiiTreatment was at maximum tolerated doses of Zepbound 10 mg or 15 mg.ATTAIN-MAINTAIN demonstrated that switching to Foundayo also supported long-term weight maintenance, meeting the primary and all key secondary endpoints using both the efficacy estimand and treatment-regimen estimand.1,2 The primary endpoint was to demonstrate that Foundayo was superior to placebo in percent maintenance of body weight reduction, among SURMOUNT-5 participants who previously reached a body weight plateau. At week 52, participants who switched from Wegovy MTD to Foundayo maintained all but 0.9 kg of their previously achieved weight loss, while those who switched from Zepbound MTD to Foundayo maintained all but 5.0 kg.ATTAIN-MAINTAIN Weight Maintenance Results
Wegovy to FoundayoivZepbound to FoundayoivAvg. starting body weighti(at start of SURMOUNT-5)113.5 kg (250.2 lbs) 115.8 kg (255.3 lbs) Avg. weight at switch to orali,ii(at start of ATTAIN-MAINTAIN)95.0 kg (209.4 lbs) 90.9 kg (200.4 lbs) Avg. weight after 52 weeks of oral maintenanceiii(at end of ATTAIN-MAINTAIN)95.9 kg (211.4 lbs) 95.9 kg (211.4 lbs) iObserved mean based on efficacy estimand data set.iiPost-hoc analysis.iiiMixed Model for Repeated Measures (MMRM) based on efficacy estimand data set.ivTreatment was at maximum tolerated doses of either 1.7 mg or 2.4 mg (Wegovy) or 10 mg or 15 mg (Zepbound)."Obesity is a chronic disease requiring long-term treatment, and patients need more options they can stay on for the long run," said Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health. "We are encouraged by the results of SURMOUNT-MAINTAIN and ATTAIN-MAINTAIN, which showed that both Zepbound and Foundayo, a once-daily oral GLP-1, provided durable weight-loss maintenance. Lilly is committed to providing people with multiple treatment options as they navigate their weight-loss journey."Across both trials, Foundayo and Zepbound demonstrated safety profiles consistent with prior Phase 3 studies. In ATTAIN-MAINTAIN, the most common adverse events with Foundayo vs. placebo were nausea (18.8% vs. 4.1%), constipation (13.1% vs. 4.1%), vomiting (8.3% vs. 3.4%) or diarrhea (7.4% vs. 7.5%). Discontinuation rates due to adverse events for patients randomized to placebo or Foundayo were 4.8% (Foundayo from Wegovy), 7.6% (placebo from Wegovy), 7.2% (Foundayo from Zepbound) and 6.3% (placebo from Zepbound). In SURMOUNT-MAINTAIN, the most common adverse events during the maintenance period with Zepbound MTD and Zepbound 5 mg vs. placebo were diarrhea (7.2% and 4.9% vs. 1.1%), vomiting (6.5% and 0.7% vs. 0%) and nausea (5.8% and 4.2% vs. 2.2%). Discontinuation rates due to adverse events during the maintenance period with Zepbound MTD, Zepbound 5 mg and placebo were 0%, 0.7% and 0%, respectively.About Zepbound
Zepbound (tirzepatide) is a once-weekly dual GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist. Zepbound is a single molecule that activates the body's receptors for GIP and GLP-1, which are natural incretin hormones. Both GIP and GLP-1 receptors are found in areas of the human brain important for appetite regulation. Zepbound decreases calorie intake, and the effects are likely mediated by affecting appetite. Studies of tirzepatide in chronic kidney disease (CKD) and in morbidity/mortality in obesity (MMO) are ongoing.Tirzepatide has been approved by the U.S. FDA as Mounjaro for adults with type 2 diabetes to improve glycemic control, and as Zepbound for adults with obesity, or some adults who are overweight and also have at least one weight-related medical problem, to lose weight and keep it off. Additionally, Zepbound is FDA-approved to treat adults with moderate-to-severe obstructive sleep apnea and obesity. Tirzepatide is also approved as Mounjaro in some countries outside the U.S. for adults with type 2 diabetes, obesity or those who are overweight who also have a weight-related comorbid condition. Both Mounjaro and Zepbound should be used in combination with diet and exercise.About the SURMOUNT-MAINTAIN trial
SURMOUNT-MAINTAIN (NCT06047548) was a 112-week, Phase 3b, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Zepbound (tirzepatide) versus placebo for maintenance of body weight reduction in adults with obesity or overweight with weight-related comorbidities, without type 2 diabetes. The study enrolled 441 participants, all of whom received open-label tirzepatide during a 60-week weight-loss period. Prior to randomization at week 60, all participants received open-label Zepbound at their maximum tolerated dose (10 mg or 15 mg), and those who achieved at least 5% weight loss and tolerated tirzepatide were then randomized in a 3:3:2 ratio to Zepbound 5 mg, Zepbound MTD, or placebo for a 52-week maintenance period.The primary endpoint was to demonstrate that continuation of tirzepatide either at a reduced 5 mg dose or at MTD is superior to placebo in percent change in body weight at week 112. For the primary endpoint, those who stayed on Zepbound MTD lost 25.2 kg (22.4%), while those who reduced to the 5 mg dose of Zepbound lost 19.2 kg (17.0%) from baseline after 60 weeks of initial weight loss and 52 weeks of maintenance.About Foundayo3
Foundayo (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake. Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, orforglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.About ATTAIN-MAINTAIN trial and ATTAIN clinical trial program
ATTAIN-MAINTAIN (NCT06584916) consisted of two 52-week, Phase 3b, randomized, double-blind, placebo-controlled cohorts comparing the efficacy and safety of once-daily Foundayo (orforglipron) for investigational use versus placebo for maintenance of body weight reduction in adults with obesity or overweight with weight-related comorbidities who previously completed the SURMOUNT-5 head-to-head trial. The ATTAIN-MAINTAIN trial randomized 376 participants across the U.S. in a 3:2 ratio to receive either Foundayo MTD 14.5 mg or 17.2 mg or placebo, as an adjunct to healthy diet and physical activity. This trial was conducted using an investigational formulation of Foundayo at dosages equivalent to Foundayo tablets.The primary endpoint was to demonstrate that Foundayo is superior to placebo in the percent maintenance of body weight reduction in participants who achieved weight plateau with either Zepbound or Wegovy in the SURMOUNT-5 trial. For the primary endpoint, participants who switched from Wegovy or Zepbound to Foundayo, respectively, maintained 82.4% and 78.0% of their previously achieved weight loss after one year. Weight plateau was defined as

In honor of its 150th anniversary, Eli Lilly and Company commits to support community organizations aiming to provide 500,000 meals and cold storage for 150 food pantriesMay 12, 2026 12:00 PM
PR Newswire (US) Through charitable support of HATCH, United Way Worldwide, United Way of Central Indiana and the Pacers Foundation, the initiative supports efforts to expand access to protein-rich food across communities nationwide, including the creation of infrastructure to deliver an estimated five million meals annually for years to come.INDIANAPOLIS, May 12, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced an initiative to support nationwide nutritious food distribution as part of the company's 150th anniversary, through charitable support of trusted community organizations in the United States. With Lilly's support, community organizations will be able to distribute approximately 500,000 meals to those in need across 15 communities.  Lilly's support will also help one of these organizations build long-term cold storage infrastructure at 150 food pantries nationwide — equipment that will support an estimated five million protein-rich meals annually.The initiative reflects Lilly's belief that food is medicine — and that access to nutritious food makes health possible. Through charitable support of HATCH, United Way Worldwide, United Way of Central Indiana, and the Pacers Foundation, the initiative supports two areas of nonprofit work: the community organizations' immediate nutritious food distribution efforts, and HATCH's development of long-term cold storage infrastructure at food pantries that will enable them to store and serve protein-rich meals year-round."As we mark 150 years, we're focused on what comes next — not just in medicine, but in how we advance health. Access to nutritious food is foundational. We're proud to support the organizations doing this work — including their efforts to build infrastructure that feeds families long after this anniversary year," said Melissa Coe, associate vice president for social impact and community engagement, Lilly.Lilly is providing charitable support to HATCH, an Indiana-based nonprofit with expertise in charitable protein distribution and cold storage infrastructure. With Lilly's support, HATCH will obtain and donate commercial-grade refrigeration systems to 150 food pantries — addressing a significant protein-access gap and enabling an estimated five million protein-rich meals annually to be provided to those in need, creating impact long after Lilly's anniversary moment."Without the right infrastructure, it's hard to get nutritious food to families in need consistently. One of the biggest challenges food pantries face is having the systems in place to properly store and distribute nutrient-dense food. We're grateful to Lilly for their willingness to support HATCH and its charitable efforts related to a long-term solution that will continue serving families long after this initiative ends," said Daniel Leckie, CEO, HATCH.In Indianapolis and Boone County, the initiative will support United Way of Central Indiana's involvement in supporting charitable food distribution at Gleaners and Second Helpings. Across 14 additional communities, United Way Worldwide will coordinate charitable food distribution and also associated volunteer opportunities for Lilly employees."In Central Indiana, we see every day how access to nutritious food shapes health, stability and opportunity. We're grateful for Lilly's leadership supporting organization's involved in charitable food distribution efforts and proud to work alongside other community members to meet immediate food needs while strengthening the infrastructure that will support our neighbors in need for years to come," said Fred Payne, president and CEO, United Way of Central Indiana.Lilly is also supporting the Pacers Foundation and its expansion of the Drive & Dish program to three new sites in Marion and Boone Counties over five years. Drive & Dish is an initiative of the Pacers Foundation, delivered in partnership with Gleaners Food Bank, that helps families in need by making healthy food more accessible while prioritizing dignity and choice.The initiative launches today and the charitable efforts of the community organizations supported by Lilly will continue throughout the year as the organizations carry out deliveries and food distributions, alongside ongoing Lilly employee volunteer opportunities — culminating in Lilly's annual Global Day of Service in September.The charitable efforts of the organization's supported by the initiative spans 15 communities: Indianapolis, Houston, Huntsville, Lehigh Valley, Richmond, Concord, Research Triangle Park, Louisville (Colorado), San Diego, Boston, Cambridge, Kenosha, San Francisco, New York, and San Juan (Puerto Rico).About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. I-LLYAbout United Way Worldwide
United Way mobilizes communities to action so all can thrive. True to our founding spirit, whenever there is a need in our communities, United Way is there. We bring a comprehensive approach to every challenge, actively listening and responding to local needs. Our reach across tens of thousands of communities means we can share innovations and scale impact to improve lives around the world.  From strengthening local resilience to advancing health, youth opportunity, and financial security, we're working towards a future where every person in every community can reach their full potential. To learn more, visit www.unitedway.org.About United Way of Central Indiana
United Way of Central Indiana is uniquely positioned to bring the resources of philanthropy, businesses, local government, nonprofits and neighborhoods together to tackle generational poverty. With a focus on basic needs, early care and learning, economic mobility, and safe and affordable housing, United Way helps people live the lives they are capable of living. United Way of Central Indiana serves Boone, Hamilton, Hancock, Hendricks, Marion, Morgan and Putnam counties. Visit uwci.org.About HATCH
Founded in 2015, HATCH is on a mission to make lasting access to complete nutrition a reality for every community. Through partnerships with hunger relief organizations nationwide, HATCH helps deliver fresh, high-quality protein to families who need it most—creating stability, dignity, and nourishment where it's often hardest to find. Guided by its "1, 2, 3 Vision," HATCH is building a future where nutritious food is not a privilege, but a shared foundation for stronger, healthier generations to come. Follow HATCH on LinkedIn, Instagram and Facebook.About Pacers Foundation
The Pacers Foundation leverages the power of basketball to create meaningful impact across Indiana by investing in programs and partnerships that empower young people and support education, health and safety initiatives. Through programs like Drive & Dish, State of Play and NBA Math Hoops, the foundation helps expand access to healthy food, youth sports and educational opportunities while strengthening communities throughout the state. The foundation also supports the work of the Fever Fund, which invests in programs and grants focused on empowering women and girls. Visit pacersfoundation.org for more information.Refer to:    Jessica Thompson; thompson_jessica @stockmama-2042 (Lilly)          View original content to download multimedia:https://www.prnewswire.com/news-releases/in-honor-of-its-150th-anniversary-eli-lilly-and-company-commits-to-support-community-organizations-aiming-to-provide-500-000-meals-and-cold-storage-for-150-food-pantries-302769772.htmlSOURCE Eli Lilly and Company Original: In honor of its 150th anniversary, Eli Lilly and Company commits to support community organizations aiming to provide 500,000 meals and cold storage for 150 food pantries

NYSE Content Update: Eli Lilly to Celebrate 150 Years of Scientific InnovationMay 11, 2026 8:55 AM
PR Newswire (US) NYSE issues a pre-market daily advisory direct from the trading floor.NEW YORK, May 11, 2026 /PRNewswire/ -- The New York Stock Exchange (NYSE) provides a daily pre-market update directly from the NYSE Trading Floor. Access today's NYSE Pre-market update for market insights before trading begins.  Ashley Mastronardi delivers the pre-market update on May 11thEquities are lower Monday morning after President Trump called an Iranian counteroffer to end the conflict in the Middle East 'totally unacceptable.'Intercontinental Exchange's (NYSE: ICE) Head of Mortgage and Housing Market Research Andy Walden will break down the May Mortgage Monitor on NYSE Live.Eli Lilly (NYSE: LLY) CFO Lucas Montarce will join NYSE Live to discuss the company's latest milestone and takeaways from its recent earnings.Once Upon a Farm's (NYSE: OFRM) behind-the-scenes footage of its February IPO will air on NYSE Live, providing viewers with new looks from the historic moment.  Opening Bell
Eli Lilly (NYSE: LLY) celebrates its 150th anniversary of foundingClosing Bell
Darling Ingredients (NYSE: DAR) celebrates its Investor Day and path to long-term growthFor market insights, IPO activity, and today's opening bell, download the NYSE TV App: TV.NYSE.com Video - https://mma.prnewswire.com/media/2976781/NYSE_Content_Update_May_11.mp4 
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Logo - https://mma.prnewswire.com/media/2581322/5962978/New_York_Stock_Exchange_Logo.jpg  View original content:https://www.prnewswire.co.uk/news-releases/nyse-content-update-eli-lilly-to-celebrate-150-years-of-scientific-innovation-302768205.html Original: NYSE Content Update: Eli Lilly to Celebrate 150 Years of Scientific Innovation

Lilly commits additional $4.5 billion across Indiana manufacturing sites, opens first dedicated genetic medicine facilityMay 6, 2026 9:00 AM
PR Newswire (US) Lilly's capital commitments to expand manufacturing in its home state now total $21 billion since 2020Lilly Lebanon Advanced Therapies opens as company's first dedicated genetic medicine manufacturing facilityLEBANON, Ind., May 6, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced an additional $4.5 billion investment across two of its three Lebanon sites—bringing the company's total Indiana capital expansion commitments since 2020 to more than $21 billion. Lilly's evolving pipeline, as well as anticipated demand for its medicines, prompted this additional commitment. The investment will incorporate new process designs and technologies at Lilly Lebanon API, one of the company's future active pharmaceutical ingredient sites, as well as Lilly Lebanon Advanced Therapies, its first dedicated genetic medicine manufacturing facility opening today.Lilly Lebanon Advanced Therapies is designed to support both clinical and commercial production of advanced therapies that target disease at the genetic level and will include a full spectrum of genetic medicine modalities from research-stage development through large-scale commercial supply. Designing and building for these modalities required developing new manufacturing processes without established commercial precedent. This facility is the first of three planned sites on the Lebanon campus, which will also include Lilly Lebanon API and the Lilly Medicine Foundry.Lebanon, Indiana, is the cornerstone of Lilly's domestic manufacturing buildout. In 2024, Lilly announced plans to make both Zepbound® (tirzepatide) and Mounjaro® (tirzepatide), the most prescribed injectable medications for weight management1 and type 2 diabetes2 respectively, at its Lebanon API site. Today's investment expands that commitment further, including planned production of Foundayo™ (orforglipron), Lilly's first FDA-approved, once-daily pill for weight loss that can be taken without food or water restrictions,3 and retatrutide, an investigational triple hormone receptor agonist in late-stage development for obesity and cardiometabolic disease."Lilly's legacy of firsts in Indiana continues today—and the best measure of that legacy is what we do next," said David A. Ricks, Lilly chair and CEO. "From genetic medicines that could one day prevent disease at its source, to Foundayo, a pill making weight loss treatment accessible to millions, we are not just discovering the medicines of the future—we are building the world's most advanced plants to make them. When our Lebanon API site opens in 2027, it will be the largest API production site in U.S. history, a commitment we chose to build here, at home.""This expansion reflects the strength of a long-standing partnership between Lilly and the state of Indiana – one that continues to deliver real results for Hoosiers," said Governor Mike Braun. "With this investment in Lebanon and across the state, Indiana is reinforcing its position as a prime destination for life sciences and advanced manufacturing, spanning innovation, production and global distribution. Together, we are helping lead the future of medicine while creating high-quality jobs and new opportunities for our communities."Lilly's manufacturing investment extends well beyond its campus walls. According to a report that will be released next week by Indiana University's Kelley School of Business, Indiana Business Research Center, "Measuring Lilly's Economic and Civic Contributions in Indiana," Lilly accounts for 70% of Indiana's pharmaceutical GDP and every Lilly job supports more than two additional jobs across the state. Further, the company estimates that for every dollar it spends in the area, up to four dollars in additional local economic activity is generated."Findings from the Kelley School's Indiana Business Research Center report demonstrate Lilly's investments in Indiana are transforming communities across the state in meaningful and far-reaching ways," IU President Pamela Whitten said. "Lilly's sustained investments since 2020 underscore the growing strength of Indiana's life sciences sector. Progress at this scale is possible only through robust partnerships, and Indiana University is moving with purpose alongside Lilly to advance innovation that improves health, prepares a world-class workforce and drives economic vitality."Lilly's U.S. capital expansion commitments since 2020 total more than $50 billion, investments made possible thanks to policies that promote domestic manufacturing. The company plans to break ground on several of its recently announced U.S. manufacturing sites this year.  Optional Quote for Media:"Today's announcement is a milestone for the City of Lebanon, a testament to the strength of our local workforce, and the vitality of our city," said Matt Gentry, Mayor of Lebanon. "Lilly has been an incredible partner, and their decision to further invest in our community ensures that Lebanon will remain at the forefront of the pharmaceutical industry for decades to come. We look forward to the continued growth and the positive impact this will have on our city and the entire state of Indiana."About Zepbound® (tirzepatide) injection 
Zepbound® (tirzepatide) is the first and only dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist obesity medication. Zepbound tackles an underlying cause of excess weight. It reduces appetite and how much you eat. Zepbound is indicated for adults with obesity, or some adults who are overweight and also have at least one weight-related medical problem, to lose weight and keep it off. Additionally, Zepbound is FDA-approved to treat adults with moderate-to-severe obstructive sleep apnea and obesity. Zepbound should be used with a reduced-calorie diet and increased physical activity. About Mounjaro®  (tirzepatide) injection
Mounjaro® (tirzepatide) is an injectable medicine for adults and children 10 years of age and older with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose). As the first and only FDA-approved GIP and GLP-1 receptor agonist, Mounjaro is a single molecule that activates the body's receptors for GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1). It is not known if Mounjaro is safe and effective for use in children under 10 years of age. About Foundayo™ (orforglipron) 
Foundayo™ (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.2 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, Foundayo is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence. About retatrutide 
Retatrutide is an investigational once-weekly triple hormone receptor agonist. Retatrutide is a single molecule that activates the body's receptors for glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), and glucagon. Lilly is studying retatrutide in several Phase 3 clinical trials to evaluate its potential efficacy and safety in obesity and overweight with at least one weight-related medical problem, type 2 diabetes, knee osteoarthritis, moderate-to-severe obstructive sleep apnea, chronic low back pain, cardiovascular and renal outcomes, and metabolic dysfunction-associated steatotic liver disease. Retatrutide is an investigational molecule that is legally available only to participants in Lilly's clinical trials. INDICATIONS AND SAFETY SUMMARY WITH WARNINGS
Zepbound® (ZEHP-bownd) is an injectable prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with: obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.  moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA. Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children. Warnings - Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider. Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound. KwikPen®: Do not share your KwikPen with other people, even if the pen needle has been changed.  You may give other people a serious infection or get a serious infection from them. Zepbound may cause serious side effects, including: Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away. Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away. Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools. Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. You may feel the pain from your abdomen to your back. Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat. Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery. Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound. Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures. Common side effects
The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn't go away. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.  Before using  Zepbound Your healthcare provider should show you how to use Zepbound before you use it for the first time. Talk to your healthcare provider about low blood sugar and how to manage it. Tell your  healthcare provider if you are taking medicines to treat diabetes including an insulin or   sulfonylurea.  If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound. Review these questions with your healthcare provider:
? Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food? 
? Do you take diabetes medicines, such as insulin or sulfonylureas?
? Do you have a history of diabetic retinopathy?
? Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
? Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
? Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound. Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Lilly at 1-800-LillyRx (1-800-545-5979). How to take Read the Instructions for Use that come with Zepbound. Use Zepbound exactly as your healthcare provider says. Use Zepbound with a reduced-calorie diet and increased physical activity. Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen), thigh, or  
have another person inject in the back of the upper arm. Do not inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously). Use Zepbound 1 time each week, at any time of the day. Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection. If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. Zepbound is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg injection. Learn more
Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to www.zepbound.lilly.com. This summary provides basic information about Zepbound but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you. ZP CON BS 25FEB2026  
Zepbound®, its delivery device base and KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. INDICATION AND SAFETY SUMMARY WITH WARNINGS
Mounjaro® (mown-JAHR-OH) is an injectable medicine for adults and children 10 years of age and older with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose).  It is not known if Mounjaro is safe and effective for use in children under 10 years of age.  Warnings - Mounjaro may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider. Do not use Mounjaro if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Mounjaro if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Mounjaro if you are allergic to it or any of the ingredients in Mounjaro. Mounjaro may cause serious side effects, including: Inflammation of the pancreas (pancreatitis). Stop using Mounjaro and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.  Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Mounjaro with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness and feeling jittery. Serious allergic reactions. Stop using Mounjaro and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.  Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away. Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Mounjaro. Tell your healthcare provider if you have stomach problems that are severe or will not go away.  Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Mounjaro. Gallbladder problems. Gallbladder problems have happened in some people who use Mounjaro. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), and clay-colored stools. Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Mounjaro may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Mounjaro before you are scheduled to have surgery or other procedures. Common side effects The most common side effects of Mounjaro include nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and stomach (abdominal) pain. These are not all the possible side effects of Mounjaro. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.  Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch. Before using Mounjaro Your healthcare provider should show you how to use Mounjaro before you use it for the first time. Talk to your healthcare provider about low blood sugar and how to manage it. If you take birth control pills by mouth, talk to your healthcare provider before you use Mounjaro. Birth control pills may not work as well while using Mounjaro. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Mounjaro and for 4 weeks after each increase in your dose of Mounjaro. Review these questions with your healthcare provider:
? Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food? 
? Do you take other diabetes medicines, such as insulin or sulfonylureas? 
? Do you have a history of diabetic retinopathy? 
? Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
? Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? It is not known if Mounjaro will harm your unborn baby. Mounjaro may pass into your breast milk. 
? Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements? How to take Read the Instructions for Use that come with Mounjaro.  Use Mounjaro exactly as your healthcare provider says.  A caregiver may give you Mounjaro injections, or you may self-inject if a healthcare provider determines that it is appropriate. Inject Mounjaro under the skin (subcutaneously) of your stomach (abdomen), thigh, or another person should inject in the back of the upper arm. Do not inject Mounjaro into a muscle (intramuscularly) or vein (intravenously). Use Mounjaro 1 time each week, at any time of the day.  Do not mix insulin and Mounjaro together in the same injection. You may give an injection of Mounjaro and insulin in the same body area (such as your stomach area), but not right next to each other. Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection. If you take too much Mounjaro, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. Learn more  
Mounjaro is a prescription medicine available as a pre-filled single-dose pen in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL injection. For more information, call 1-800-LillyRX (800-545-5979) or go to www.mounjaro.lilly.com. This summary provides basic information about Mounjaro but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Mounjaro and how to take it. Your healthcare provider is the best person to help you decide if Mounjaro is right for you. TR CON BS  19DEC2025
Mounjaro® and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. INDICATION AND SAFETY SUMMARY WITH WARNINGS
Foundayo™ (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.  Foundayo should not be used with other GLP-1 receptor agonist medicines. It is not known if Foundayo is safe and effective for use in children.  Warnings – Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider. Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo.  Foundayo may cause serious side effects, including: Inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.  Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away. Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away. Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery.  Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat. Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo. Gallbladder problems.  Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools. Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures.  Common side effects
The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch. Before taking Foundayo Tell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works. Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo. Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. Review these questions with your healthcare provider:  
? Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
? Do you have a history of diabetic retinopathy?
? Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
? Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby. 
? Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo.
? Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements? How to take Take Foundayo exactly as your healthcare provider tells you to. Use Foundayo with a reduced-calorie diet and increased physical activity. Take Foundayo by mouth 1 time each day, with or without food. Swallow tablets whole. Do not break, crush, or chew the tablet.  If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day. Do not take more than 1 tablet per day. If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment. If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.  Learn more
Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com.  This summary provides basic information about Foundayo but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you. OG CON BS APR2026
Foundayo™ is a trademark of Eli Lilly and Company. Endnotes and References  
1.   Based on IQVIA® National Prescription Audit Data as of April 16, 2026. 
2.   Data based on IQVIA® APLD Claims Data as of January 23, 2026.
3.   Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. https://doi.org/10.1007/s13300-024-01554-1. Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152. About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. C-LLYTrademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.Cautionary Statement Regarding Forward-Looking Statements  
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995), including about planned capital investments in new manufacturing capacity, production and delivery of medicines, including Foundayo and retatrutide, hiring and related initiatives and the economic impact thereof and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in the manufacturing process, development and commercialization of pharmaceutical products any of which could impact the overall commercial success of our products, and as related to cost, completion timing, expected capacity, personnel, and other factors which could impact expected benefits of the capacity expansion and related initiatives. For further discussion of risks and uncertainties relevant to Lilly's business that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.   Refer to:  Erica Hiquet, erica.hiquet @RGrant26-7498 (Media)  
Michael Czapar; czapar_michael_c @orion-0983 (Investors)   View original content to download multimedia:https://www.prnewswire.com/news-releases/lilly-commits-additional-4-5-billion-across-indiana-manufacturing-sites-opens-first-dedicated-genetic-medicine-facility-302763332.htmlSOURCE Eli Lilly and Company Original: Lilly commits additional $4.5 billion across Indiana manufacturing sites, opens first dedicated genetic medicine facility

Lilly's Omvoh (mirikizumab-mrkz) is the first and only IL-23p19 to demonstrate durable disease clearance in ulcerative colitis through four yearsMay 5, 2026 6:45 AM
PR Newswire (US) In LUCENT-3, more than 60% of patients who achieved disease clearance at one year maintained it after four years of continuous Omvoh treatmentDisease clearance is a high clinical bar in UC requiring simultaneous symptomatic, endoscopic and histologic remission INDIANAPOLIS, May 5, 2026 /PRNewswire/ -- New long-term data from Eli Lilly and Company (NYSE: LLY) show patients with moderately to severely active ulcerative colitis (UC) treated with Omvoh (mirikizumab-mrkz) achieved durable disease clearance through four years of continuous treatment. In the LUCENT-3 open-label extension study, 63.5% of Omvoh-treated patients who achieved disease clearance at one year sustained it at four years. These results will be presented at Digestive Disease Week® (DDW) and represent the first time an interleukin-23p19 (IL-23p19) inhibitor has demonstrated durable disease clearance through four years in people with UC.1 Disease clearance is the simultaneous achievement of symptomatic, endoscopic and histologic remission. In real-world studies, achieving disease clearance has been associated with reduced rates of hospitalizations and surgery.2-3 While previously reported four-year Omvoh data showed durable individual outcomes, this new analysis goes further by evaluating those outcomes together as a composite endpoint, reflecting a higher clinical bar."Ulcerative colitis is a lifelong disease, and every person living with the condition deserves a treatment that can deliver strong and durable disease control, not just symptom relief," said Adrienne Brown, executive vice president and president of Lilly Immunology. "Disease clearance sets that bar higher, and these data show Omvoh-treated patients achieved and sustained it over four years with consistent monthly dosing."Durable Disease Clearance in Ulcerative Colitis
Disease clearance was evaluated among patients who achieved clinical remission with Omvoh at one year in the LUCENT-2 maintenance study and continued treatment in LUCENT-3, an open-label extension study. This analysis, which was not pre-specified, showed 63.5% of Omvoh-treated patients who achieved disease clearance at one year sustained it at four years.* Even at the most stringent measure — requiring endoscopic normalization in addition to symptomatic and histologic remission — 61.3% of patients who achieved it at one year maintained it through four years.†"What makes these data so compelling is that they go beyond individual measures of improvement to show that patients treated with Omvoh achieved disease clearance, with simultaneous symptomatic, endoscopic and histologic remission, maintained over four years," said Jean-Frédéric Colombel, M.D., director of the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at the Icahn School of Medicine at Mount Sinai. "Until now, disease clearance has not been demonstrated for this length of time for any IL-23p19 therapy in ulcerative colitis. For a progressive disease like ulcerative colitis, that level of durable remission has the potential to change the long-term course of the disease for patients." These findings expand the growing body of long-term data on Omvoh in inflammatory bowel disease (IBD), building on previously disclosed four-year results in UC and three-year results in Crohn's disease, including reduction of serious disease-related complications. In LUCENT-3, one UC-related hospitalization and zero UC-related surgeries were reported by patients treated with Omvoh during the three-year long-term extension.4The long-term safety profile in patients with moderately to severely active UC was consistent with the known safety profile of Omvoh with no new safety signals observed. Of patients who completed one year of blinded Omvoh maintenance therapy in LUCENT-2 and continued on to LUCENT-3, 12% reported a serious adverse event, while 7% discontinued treatment due to an adverse event.5 The most common adverse reactions (reported in at least 2% of subjects at a higher frequency than placebo) associated with Omvoh treatment in LUCENT-1 and -2 were upper respiratory tract infections, injection site reactions, arthralgia, rash, headache and herpes viral infection.6Lilly continues to advance the standard of care in gastroenterology through the next wave of immunology innovation, including combination approaches, novel mechanisms and the potential of incretins. In UC, Lilly is pursuing combination studies of mirikizumab aimed at delivering breakthrough induction efficacy while maintaining long-term remission and safety. These include studies with eltrekibart (NCT06598943), a monoclonal antibody that targets neutrophil-driven inflammation, and with zotemtegrast (NCT07186101), an oral a4ß7 integrin inhibitor. The COMMIT-UC (NCT06937086) and COMMIT-CD (NCT06937099) trials are investigating the concomitant use of mirikizumab and an incretin-based therapy in adults with UC or Crohn's disease and obesity or overweight with at least one additional weight-related comorbid condition. In addition, trials of mirikizumab in pediatric patients are ongoing in UC (NCT05784246) and Crohn's disease (NCT05509777).Omvoh has received regulatory approvals for the treatment of moderately to severely active UC and moderately to severely active Crohn's disease in adults and has been approved in 47 countries around the world. In the U.S., Omvoh is also approved for a single-injection maintenance regimen in UC.About the LUCENT Clinical Trial Program
Omvoh was studied in two Phase 3 clinical trials which evaluated the efficacy and safety of Omvoh in adults with moderately to severely active UC, in both biologic-naïve patients and those who had previously failed a biologic or Janus kinase inhibitor (JAKi).The randomized, double-blind, placebo-controlled LUCENT-1 (induction) study included patients with an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, biologic therapy, or JAKi, and LUCENT-2 (maintenance) evaluated continued treatment versus placebo in patients who achieved a clinical response to Omvoh in LUCENT-1.5LUCENT-3, the single-arm long-term Phase 3 open-label extension of LUCENT-1 and LUCENT-2, evaluated the efficacy and safety of Omvoh in patients with UC for an additional three years of treatment (up to four years total).Using a modified non-responder imputation analysis to handle discontinuation and missing data, 49.7% and 42.8% of patients who achieved disease clearance and stringent disease clearance at one year, respectively, sustained it at four years.1About Omvoh
Omvoh (mirikizumab-mrkz) is an interleukin-23p19 (IL-23p19) antagonist indicated for the treatment of moderately to severely active ulcerative colitis and Crohn's disease in adults. Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of inflammatory bowel disease.6Omvoh and its delivery device base are trademarks owned by Eli Lilly and Company.Endnotes and References
*Observed cases, post hoc. Symptomatic remission [Mayo stool frequency (SF)=0, or SF=1 with a ≥1-point decrease from baseline, and rectal bleeding=0], and histologic-endoscopic mucosal remission [Histologic remission (Geboes score ≤2B.0) and endoscopic remission (endoscopic subscore [ES] of 0 or 1, excluding friability)].
†Observed cases, post hoc. Symptomatic + histologic remission + endoscopic normalization (ES=0).
1Magro F, et al. Mirikizumab demonstrates consistent and sustained disease clearance at four years of treatment in patients with moderately to severely active ulcerative colitis. Digestive Disease Week 2026. May 2-5, 2026.
2Andronic AM, et al. J Crohn's Colitis. 2023;17(Supplement_1):i529. https://doi.org/10.1093/ecco-jcc/jjac190.0528
3Pai RK, et al. Expert Rev Gastroenterol Hepatol. 2024;18(1-3):73–87. https://doi.org/10.1080/17474124.2024.2326838
4Magro F, et al. J Crohn's Colitis. 2026;20(Suppl 1):jjaf231.1300. https://doi.org/10.1093/ecco-jcc/jjaf231.1300
5Sands, B, et al. Mirikizumab provides sustained long-term efficacy up to 4 years of treatment for ulcerative colitis: final results from the LUCENT-3 open-label extension study. 2025 United European Gastroenterology Week. October 4-7, 2025.
6Omvoh. Prescribing Information. Lilly USA, LLC.Indications and Usage for Omvoh® (mirikizumab-mrkz) (in the United States)
Omvoh is an interleukin-23 antagonist indicated for adults with:Moderately to severely active ulcerative colitisModerately to severely active Crohn's diseaseImportant Safety Information for Omvoh (mirikizumab-mrkz)CONTRAINDICATIONS Omvoh is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.WARNINGS AND PRECAUTIONS Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis during intravenous infusion, have been reported with Omvoh administration. Infusion-related hypersensitivity reactions, including mucocutaneous erythema and pruritus, were reported during induction. If a severe hypersensitivity reaction occurs, discontinue Omvoh immediately and initiate appropriate treatment.Infections
Omvoh may increase the risk of infection. Do not initiate treatment with Omvoh in patients with a clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and bene?ts prior to prescribing Omvoh. Instruct patients to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur. If a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely and do not administer Omvoh until the infection resolves.Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Omvoh. Do not administer Omvoh to patients with active TB infection. Initiate treatment of latent TB prior to administering Omvoh. Consider anti-TB therapy prior to initiation of Omvoh in patients with a history of latent or active TB in whom an adequate course of treatment cannot be con?rmed. Monitor patients for signs and symptoms of active TB during and after Omvoh treatment. In clinical trials, subjects were excluded if they had evidence of active TB, a history of active TB, or were diagnosed with latent TB at screening.Hepatotoxicity
Drug-induced liver injury in conjunction with pruritus was reported in a clinical trial subject following a longer than recommended induction regimen. Omvoh was discontinued. Liver test abnormalities eventually returned to baseline. Evaluate liver enzymes and bilirubin at baseline and for at least 24 weeks of treatment. Monitor thereafter according to routine patient management. Consider other treatment options in patients with evidence of liver cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.Immunizations
Avoid use of live vaccines in patients treated with Omvoh. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or non-live vaccines in patients treated with Omvoh.ADVERSE REACTIONS
Most common adverse reactions associated with Omvoh (≥2% of subjects and at a higher frequency than placebo) in ulcerative colitis treatment are upper respiratory tract infections and arthralgia during the induction study (UC-1), and upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection during the maintenance study (UC-2). Most common adverse reactions associated with Omvoh in the Crohn's disease study (CD-1) (≥5% of subjects and at a higher frequency than placebo) are upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests.Omvoh injection is available as a 300 mg/15 mL solution in a single-dose vial for intravenous infusion, and as a 100 mg/mL solution or a 200 mg/2 mL solution in a single dose pre?lled pen or pre?lled syringe for subcutaneous injection. Refer to the Prescribing Information for dosing information.MR HCP ISI CD APPClick to access provided Prescribing Information and Medication Guide. See Instructions for Use provided with the device.About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLYTrademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Omvoh (mirikizumab-mrkz) as a treatment for people with moderate to severe ulcerative colitis and moderate to severe Crohn's disease and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that Omvoh will receive additional regulatory approvals, or that Omvoh will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.Refer to: Kelly Hoffman; kelly.hoffman @Fitz-2555 (Lilly media)
Michael Czapar; czapar_michael_c @orion-0983 (Investors)   View original content to download multimedia:https://www.prnewswire.com/news-releases/lillys-omvoh-mirikizumab-mrkz-is-the-first-and-only-il-23p19-to-demonstrate-durable-disease-clearance-in-ulcerative-colitis-through-four-years-302760458.htmlSOURCE Eli Lilly and Company Original: Lilly's Omvoh (mirikizumab-mrkz) is the first and only IL-23p19 to demonstrate durable disease clearance in ulcerative colitis through four years

Novo Nordisk’s Weight-Loss Pill Momentum Faces Pricing PressureMay 5, 2026 6:27 AM
IH Market News Novo Nordisk A/S (NYSE:NVO) is experiencing strong early uptake for its new weight-loss pill, but intensifying competition with U.S. rival Eli Lilly and Company (NYSE:LLY) is raising concerns about whether growing prescription volumes can offset mounting pricing pressure in the obesity drug market.The Danish drugmaker is set to report first-quarter earnings on Wednesday, with a heavy focus on the pill’s performance as it seeks to regain market share. The broader outlook for obesity treatments has become less certain, as U.S. pricing declines and increased competition challenge earlier projections of a $150 billion global market within the next decade. A Critical Moment for Novo The company has spent much of the past year under pressure, following setbacks including underwhelming trial results for its next-generation obesity treatment, reduced guidance, leadership changes and a significant share price decline that has erased more than $400 billion in market value since its 2024 peak.“We are in the middle of the exam period, let’s put it that way,” said Mikael Bak, head of the Danish Shareholders’ Association.“What I will be looking for is whether they are increasingly able to go from being rather defensive to being more offensive.” Strong Early Demand for Oral Wegovy Initial prescription data for Novo’s oral Wegovy treatment has exceeded expectations. According to figures from research firm IQVIA Holdings Inc., around 721,000 prescriptions were recorded in the U.S. during the first quarter, noted BMO Capital Markets analyst Evan Seigerman.However, Novo’s first-mover advantage ended in early April when Eli Lilly secured approval for its competing pill, Foundayo, setting up direct competition in the oral obesity segment.In a potentially encouraging sign for the sector, Eli Lilly recently reported stronger-than-expected quarterly results, boosting both its own shares and those of Novo, supported by robust demand for its weight-loss and diabetes treatments Zepbound and Mounjaro. Volume Growth vs Revenue Pressure Seigerman cautioned that it may be too early to draw firm conclusions from the initial launch data, noting that IQVIA figures exclude some prescriptions filled through telehealth providers, suggesting actual patient numbers could be higher.At the same time, analysts warn that strong prescription volumes may not translate into equally strong revenue. Approximately 450,000 prescriptions were for the lowest 1.5 mg starter dose, priced at $149 per month. BMO Capital Markets estimates that first-quarter pill revenue could fall about 12% short of the roughly $1 billion consensus forecast.“The initial launch has gone better than people thought,” said Barclays analyst James Gordon. “But are some people just starting on the cheap low dose and staying on it because it’s cheaper and they don’t need the higher efficacy and cost delivered by higher doses? There are still quite a lot of moving parts, even before Lilly’s competing oral product makes an impact”.Patients typically begin treatment at lower doses and gradually move higher over time. A slower transition to higher doses could weigh on revenue even if prescription growth remains strong.Novo declined to comment ahead of its results due to regulatory restrictions.Gordon added that prescriptions for the starter dose appear to have plateaued, while uptake of higher doses has been slower than expected. He suggested that some patients may be remaining on lower-cost doses longer, while others may be discontinuing treatment altogether. Pricing Pressures Build Novo shareholder Lukas Leu acknowledged the strong initial launch but highlighted risks from intensifying price competition, particularly as rivals expand and U.S. President Donald Trump pushes to lower drug costs.“The launch is definitely strong – I think no one wants to debate about that,” Leu said. “What we don’t know yet is whether it will compensate Novo for the price decline, which is faster.”Some investors expect Novo to maintain its full-year guidance while waiting for clearer data on how the pill performs against Eli Lilly’s rival product. Others anticipate a possible increase at the lower end of the forecast range. Competition with Eli Lilly in Focus Investor sentiment toward Novo is increasingly shaped by comparisons with Eli Lilly, with some arguing the U.S. company has moved more decisively in advancing its pipeline and executing strategic deals.“We see early but preliminary signs of progress. But it is still early stage – the future will show whether it is actually enough,” said Anders Schelde of AkademikerPension.Novo Nordisk stock priceEli Lilly stock price Original: Novo Nordisk’s Weight-Loss Pill Momentum Faces Pricing Pressure

Lilly declares second-quarter 2026 dividendMay 4, 2026 11:11 AM
PR Newswire (US)

INDIANAPOLIS, May 4, 2026 /PRNewswire/ -- The board of directors of Eli Lilly and Company (NYSE: LLY) has declared a dividend for the second quarter of 2026 of $1.73 per share on outstanding common stock.The dividend is payable on June 10, 2026, to shareholders of record at the close of business on May 15, 2026.About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. F-LLYCautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about expected dividend payments and reflects Lilly's current beliefs and expectations. However, there are significant risks and uncertainties in pharmaceutical research and development, as well as in business development activities and capital allocation strategies related to the company's business and actual results may differ materially due to various factors. For further discussion of risks and uncertainties relevant to Lilly's business that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.Refer to:Ashley Hennessey; gentry_ashley_jo @lmastro-4363 (Media)
Michael Czapar; czapar_michael_c @orion-0983 (Investors)  





View original content to download multimedia:https://www.prnewswire.com/news-releases/lilly-declares-second-quarter-2026-dividend-302761455.htmlSOURCE Eli Lilly and Company

Original: Lilly declares second-quarter 2026 dividend

Tech Stocks Set to Extend Rally as Apple Crushes Estimates: Dow Jones, S&P and Nasdaq FuturesMay 1, 2026 9:09 AM
IH Market News
Dow Jones, S&P 500 and Nasdaq futures are currently pointing to a higher open on Friday, with stocks likely to see further upside following the rally seen over the course of the previous session.Apple (NASDAQ:AAPL) may help lead an extended advance on Wall Street, as the tech giant is surging by 3.6 percent in pre-market trading.The jump by Apple comes after the company reported fiscal better than expected fiscal second quarter results and forecast revenues for the current quarter above analyst estimates.Early buying interest may also be generated by an extended pullback by the price of crude oil, with U.S. crude oil futures tumbling by more than 2 percent.U.S. crude oil futures showed a significant downturn on Thursday, slumping by 1.7 percent after reaching their highest levels in four years.The continued decrease by crude oil prices comes after an Axios reporter said Iran has delivered its response to the latest U.S. amendments on the agreement to end the war through Pakistani mediators.After seeing considerable volatility early in the session, stocks moved sharply higher over the course of the trading day on Thursday. The major averages all showed strong moves to the upside, with the Nasdaq and the S&P 500 reaching new record closing highs.The major averages gave back some ground going into the end of the day but still posted strong gains. The Dow surged 790.33 points or 1.6 percent to 49,652.14, the S&P 500 jumped 73.06 points or 1 percent to 7,209.01 and the Nasdaq advanced 219.08 points or 0.9 percent to 24,892.31.The Dow turned in a strong performance throughout the day amid a sharp increase by shares of Caterpillar (NYSE:CAT), with the construction equipment spiking by 9.9 percent.Shares of Caterpillar soared after the company reported better than expected first quarter results and raised its full-year revenue forecast.Chipmaker Qualcomm (NASDAQ:QCOM) also skyrocketed by 15.1 percent on the day after reporting second quarter earnings that exceeded analyst estimates.Shares of Alphabet (NASDAQ:GOOGL) also surged by 10 percent after the Google parent better than expected first quarter revenues.On the other hand, Facebook parent Meta Platforms (NASDAQ:META) and software giant Microsoft (NASDAQ:MSFT) moved sharply lower amid concerns about their plans to increase spending.Traders also kept an eye on the price of crude oil, which pulled back sharply after soaring to its highest levels in four years despite lingering concerns about the Middle East conflict.Networking stocks turned in some of the market’s best performances on the day, with the NYSE Arca Networking Index spiking by 3.8 percent to a new record closing high.Substantial strength was also visible among pharmaceutical stocks, as reflected by the 3.7 percent surge by the NYSE Arca Pharmaceutical Index.Eli Lilly (NYSE:LLY) helped lead the sector higher, soaring by 9.8 percent after reporting better than expected first quarter results and raising its full-year sale outlook.Computer hardware, gold, telecom and semiconductor stocks also saw significant strength, while software stocks bucked the uptrend amid the steep drop by Microsoft.

Original: Tech Stocks Set to Extend Rally as Apple Crushes Estimates: Dow Jones, S&P and Nasdaq Futures

Lilly jumps on strong Q1 results and upgraded outlookApril 30, 2026 10:19 AM
IH Market News
Eli Lilly and Company (NYSE:LLY) reported first-quarter results on Thursday that comfortably exceeded analyst expectations and lifted its full-year guidance, sending shares more than 5% higher in premarket trading.Adjusted earnings per share came in at $8.55, well above the $6.97 consensus estimate by $1.58.Revenue reached $19.8 billion, surpassing forecasts of $17.6 billion and marking a sharp 56% increase from $12.7 billion in the same quarter last year.The surge in revenue was largely driven by a 65% increase in volume, partially offset by a 13% decline due to lower realized prices for Mounjaro and Zepbound.Lilly raised its full-year 2026 revenue outlook to between $82.0 billion and $85.0 billion, up from the previous range of $80.0 billion to $83.0 billion. The midpoint of $83.5 billion is above the $81.67 billion analyst consensus.The company also lifted its adjusted EPS guidance to a range of $35.50 to $37.00, compared with its prior forecast of $33.50 to $35.00. The midpoint of $36.25 exceeds the $34.53 consensus estimate.“2026 is off to a strong start, we delivered 56% revenue growth in the first quarter and raised our full-year revenue guidance by $2 billion,” said Chair and CEO David A. Ricks. “A key milestone was the U.S. FDA approval of Foundayo—the only approved GLP-1 pill that can be taken any time of day, without food and water restrictions.”Sales of Mounjaro surged 125% to $8.7 billion, while Zepbound revenue rose 80% to $4.2 billion.U.S. revenue increased 43% to $12.1 billion, while international revenue climbed 81% to $7.7 billion.Adjusted gross margin stood at 82.6% of revenue, down 0.9 percentage points from a year earlier, mainly reflecting lower realized pricing.Eli Lilly stock price

Original: Lilly jumps on strong Q1 results and upgraded outlook

Lilly reports first-quarter 2026 financial results, raises full year guidance, and highlights momentum of new medicinesApril 30, 2026 6:45 AM
PR Newswire (US)

Revenue in Q1 2026 increased 56% to $19.8 billion primarily driven by volume growth, partially offset by lower realized prices from Mounjaro and Zepbound.Q1 2026 EPS increased by 170% to $8.26 on a reported basis and increased by 156% to $8.55 on a non-GAAP basis. The Q1 2026 reported and non-GAAP EPS included $0.52 of acquired IPR&D charges compared to $1.72 in Q1 2025.Increased 2026 full-year revenue guidance to be in the range of $82.0 billion to $85.0 billion and non-GAAP EPS guidance to be in the range of $35.50 to $37.00.Regulatory progress included U.S. FDA approval of Foundayo (orforglipron) for adults with obesity, or overweight with weight-related medical problems. Pipeline progress included positive Phase 3 results from Foundayo (orforglipron) in adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk, Jaypirca in combination with venetoclax and rituximab in relapsed or refractory CLL or SLL, Taltz and Zepbound used together for adults with psoriasis and obesity or overweight, and retatrutide in type 2 diabetes.Business development activity included the agreements to acquire Orna Therapeutics, Centessa Pharmaceuticals plc., Kelonia Therapeutics, and Ajax Therapeutics.Company announces planned Investment Community Meeting for December 7, 2026INDIANAPOLIS, April 30, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced its financial results for the first quarter of 2026 and provided updated 2026 financial guidance."2026 is off to a strong start, we delivered 56% revenue growth in the first quarter and raised our full-year revenue guidance by $2 billion," said David A. Ricks, Lilly chair and CEO. "A key milestone was the U.S. FDA approval of Foundayo—the only approved GLP-1 pill that can be taken any time of day, without food and water restrictions. Foundayo will meaningfully expand the number of people who can benefit from GLP-1s. We also delivered pipeline progress across all four therapeutic areas and continued investing in Lilly's future growth through four acquisitions."Financial Results





$ in millions, except per share dataFirst-Quarter
2026
2025
% ChangeRevenue$   19,799
$   12,729
56 %





Net income – Reported7,396
2,759
168 %Earnings per share – Reported8.26
3.06
170 %





Net income – Non-GAAP7,663
3,004
155 %Earnings per share – Non-GAAP8.55
3.34
156 %





A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."First-Quarter Reported Results
In Q1 2026, worldwide revenue was $19.8 billion, an increase of 56% compared with Q1 2025, driven by a 65% increase in volume, partially offset by a 13% decrease due to lower realized prices. Key Products1 revenue grew to $13.4 billion in Q1 2026, led by Mounjaro and Zepbound. Key Products revenue in the Immunology, Oncology, and Neuroscience therapeutic areas grew 160% in Q1 2026 compared to Q1 2025.Revenue in the U.S. increased 43% to $12.1 billion, driven by a 49% increase in volume, partially offset by a 7% decrease due to lower realized prices. The increase in U.S. volume was driven by Zepbound and Mounjaro and the decline in realized prices was primarily driven by Zepbound and Taltz.Revenue outside the U.S. increased 81% to $7.7 billion, driven by a 95% increase in volume, partially offset by a 25% decrease due to lower realized prices. The lower realized prices outside the U.S. were driven primarily by the addition of Mounjaro to the National Reimbursed Drug List (NRDL) in China. The volume increase outside the U.S. was driven by Mounjaro. Jardiance revenue outside the U.S. included one-time benefits of $250 million in Q1 2026 compared to $370 million in Q1 2025, associated with the company's collaboration with Boehringer Ingelheim.1 The Company currently defines Key Products as Ebglyss, Inluriyo, Jaypirca, Kisunla, Mounjaro, Omvoh, and Zepbound. Effective Q1 2026, Verzenio is excluded from Key Products.Gross margin increased 54% to $16.2 billion in Q1 2026. Gross margin as a percent of revenue was 81.9%, a decrease of 0.6 percentage points versus the same quarter last year. The change was primarily driven by lower realized prices.In Q1 2026, research and development expenses increased 28% to $3.5 billion, or 18% of revenue, driven by continued investments in the company's early and late-stage portfolio.Marketing, selling, and administrative expenses increased 19% to $2.9 billion in Q1 2026, primarily driven by promotional efforts supporting ongoing and planned launches.In Q1 2026, the company recognized acquired in-process research and development (IPR&D) charges of $584 million compared with $1.6 billion in Q1 2025. The Q1 2025 charges primarily related to the acquisition of Scorpion Therapeutics, Inc.'s PI3Ka inhibitor program STX-478.Asset impairment, restructuring and other special charges of $279 million in Q1 2026 were primarily related to litigation matters. In Q1 2025, there was a charge of $35 million related to intangible asset impairments.The effective tax rate was 16.4% in Q1 2026 compared with 20.2% in Q1 2025, primarily driven by the unfavorable tax impact of a non-deductible acquired IPR&D charge in Q1 2025. The 2026 and 2025 effective tax rates were impacted by net discrete tax benefits in each period.In Q1 2026, net income and earnings per share (EPS) were $7.4 billion and $8.26, respectively, compared with net income of $2.8 billion and EPS of $3.06 in Q1 2025. EPS in Q1 2026 and Q1 2025 included acquired IPR&D charges of $0.52 and $1.72, respectively.First-Quarter Non-GAAP Measures
On a non-GAAP basis, Q1 2026 gross margin increased 54% to $16.4 billion. Gross margin as a percent of revenue was 82.6%, a decrease of 0.9 percentage points versus the same quarter last year. The change was primarily driven by lower realized prices.The non-GAAP effective tax rate was 16.5% in Q1 2026 compared with 20.2% in Q1 2025, primarily driven by the unfavorable tax impact of a non-deductible acquired IPR&D charge in Q1 2025. The 2026 and 2025 effective tax rates were impacted by net discrete tax benefits in each period.On a non-GAAP basis, Q1 2026 net income and EPS were $7.7 billion and $8.55, respectively, compared with net income of $3.0 billion and EPS of $3.34 in Q1 2025. Non-GAAP EPS in Q1 2026 and Q1 2025 included acquired IPR&D charges of $0.52 and $1.72, respectively.For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)" table later in this press release.
First-Quarter
2026
2025
% ChangeEarnings per share (reported)$       8.26
$       3.06
170 %Amortization of intangible assets.11
.11

Asset impairment, restructuring and other special charges.25
.03

Net losses (gains) on investments in equity securities(.07)
.13

Earnings per share (non-GAAP)$       8.55
$       3.34
156 %





Acquired IPR&D.52
1.72
(70) %Numbers may not add due to rounding





Selected Revenue Highlights




(Dollars in millions)First-QuarterSelected Products2026
2025
% ChangeMounjaro$       8,662
$       3,842
125 %Zepbound(1)4,160
2,312
80 %Jaypirca165
92
79 %Ebglyss145
60
141 %Kisunla124
22
NMOmvoh80
37
115 %Inluriyo35
—
NMTotal Revenue19,799
12,729
56 %





(1) Tirzepatide is marketed for obesity under the brand name Zepbound in Canada, Japan, and the
United States.NM - not meaningfulMounjaro
For Q1 2026, worldwide Mounjaro revenue increased 125% to $8.7 billion. U.S. revenue was $4.2 billion, an increase of 59%, reflecting strong demand, partially offset by lower realized prices. Lower realized prices were partially offset by a favorable one-time adjustment to estimates for rebates and discounts in Q1 2026. Revenue outside the U.S. increased to $4.4 billion compared with $1.2 billion in Q1 2025, primarily driven by volume growth, partially offset by lower realized prices driven by the addition of Mounjaro to the NRDL within the China market.Zepbound
For Q1 2026, U.S. Zepbound revenue increased 79% to $4.1 billion, compared with $2.3 billion in Q1 2025, primarily driven by strong demand, partially offset by lower realized prices, including previously announced reductions in cash pay prices. Lower realized prices were partially offset by a favorable one-time adjustment to estimates for rebates and discounts in Q1 2026. Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including:RegulatoryFDA approves Lilly's Foundayo™ (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions (announcement)Lilly's Olumiant (baricitinib) recommended by CHMP for approval of expanded use in the European Union for adolescents with severe alopecia areata (announcement)Zepbound (tirzepatide), the most prescribed weight management medication in 2025, now available in multi-dose KwikPen (announcement)ClinicalACHIEVE-4, the longest Phase 3 study of Lilly's Foundayo (orforglipron) to date, reaffirmed its cardiovascular and overall safety profile as well as consistent improvements across key measures of cardiometabolic health (announcement)Lilly's Jaypirca (pirtobrutinib) significantly extended progression-free survival when added to a venetoclax time-limited regimen in patients with previously treated CLL/SLL (announcement)Phase 3b data presented at AAD Annual Meeting show Lilly's Taltz (ixekizumab) plus Zepbound (tirzepatide) delivered superior efficacy for adults with psoriatic arthritis and obesity (announcement)Lilly's EBGLYSS (lebrikizumab-lbkz) delivered up to four years of durable disease control for patients with moderate-to-severe atopic dermatitis (announcement)Lilly's triple agonist, retatrutide, demonstrated significant reductions in A1C and weight in first Phase 3 trial for treatment of type 2 diabetes (announcement)Lilly's EBGLYSS (lebrikizumab-lbkz) is the first and only selective IL-13 inhibitor to deliver positive Phase 3 outcomes in patients aged six months to 18 years with moderate-to-severe atopic dermatitis (announcement)Lilly's oral GLP-1, orforglipron, delivered superior blood sugar control and weight loss compared to oral semaglutide in head-to-head type 2 diabetes trial published in The Lancet (announcement)Patients with Crohn's disease maintained steroid-free remission for three years with Lilly's Omvoh (mirikizumab-mrkz) (announcement)Lilly's Taltz (ixekizumab) and Zepbound (tirzepatide) used together delivered superior efficacy in first-of-its-kind Phase 3b trial for adults with psoriasis and obesity or overweight (announcement)Lilly's Retevmo (selpercatinib) delivers substantial event-free survival benefit as an adjuvant therapy in early-stage RET fusion-positive lung cancer (announcement)OtherLilly to acquire Ajax Therapeutics to advance outcomes for patients with myelofibrosis and polycythemia vera (announcement)Lilly to acquire Kelonia Therapeutics to advance in vivo CAR-T cell therapies (announcement)Foundayo™ (orforglipron), Lilly's new oral GLP-1 pill for weight loss, now available in the U.S. (announcement)Lilly to acquire Centessa Pharmaceuticals to advance treatments for sleep-wake disorders (announcement)Lilly Employer Connect platform launches with over fifteen independent program administrators offering tailored obesity coverage options to expand access to patients (announcement)Lilly to acquire Orna Therapeutics to advance cell therapies (announcement)For information on important public announcements, visit the news section of Lilly's website.2026 Financial Guidance 
In addition to providing guidance for GAAP revenue, Lilly provides guidance for certain non-GAAP measures.The following table summarizes the company's updated full-year 2026 non-GAAP financial guidance, reflecting the strong revenue performance in Q1:


PriorUpdated




Revenue

$80 to $83 billion$82 to $85 billion




Performance Margin(1)(2)

46.0% to 47.5%47.0% to 48.5%




Tax Rate(1)(3)

18% to 19%Unchanged




Earnings per Share(1)(3)(4)

$33.50 to $35.00$35.50 to $37.00




(1) Lilly does not provide reconciliations of forward-looking non-GAAP measures to the most directly comparable GAAP measures
because comparable GAAP measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and
quantifying measures that would be necessary for a reconciliation. In particular, Lilly cannot reasonably predict certain items including
net gains and losses on equity securities, asset impairment, acquisition or divestiture-related items, restructuring and other adjustments,
without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on Lilly's reported
results in accordance with GAAP. See Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited) table
below for additional Non-GAAP information.(2) The company defines performance margin as gross margin less research and development and marketing, selling, and administrative
expenses divided by revenue. (3) Guidance does not include acquired in-process research and development (IPR&D) incurred after March 31, 2026. (4) 2026 assumes shares outstanding of approximately 895 million and foreign currency exchange rate assumptions of 1.16 (Euro), 153
(Yen) and 7.1 (Yuan)Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the Q1 2026 financial results conference call through a link on Lilly's website at investor.lilly.com/webcasts-and-presentations. The conference call will begin at 10 a.m. Eastern time today and will be available for replay via the website.Non-GAAP Financial Measures
Certain financial information is presented on both a reported and a non-GAAP basis. Some numbers in this press release may not add due to rounding. Reported results were prepared in accordance with U.S. generally accepted accounting principles (GAAP) and include all revenue and expenses recognized during the periods. Historical non-GAAP measures reflect adjustments for the items described in the reconciliation tables later in the release. Related materials provide certain GAAP and non-GAAP figures excluding the impact of foreign exchange rates. Lilly recalculates current period figures on a constant currency basis by keeping constant the exchange rates from the base period. The company's 2026 financial guidance (other than revenue) is provided on a non-GAAP basis, as described in "2026 Financial Guidance" above. Non-GAAP measures are presented to provide additional insights into the underlying trends in the company's business.About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news. F-LLYCautionary Statement Regarding Forward-Looking Statements
This press release and the related attachments contain management's intentions and expectations for the future, all of which are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "estimate", "project", "intend", "expect", "believe", "target", "plan", "anticipate", "may", "could", "aim", "seek", "will", "continue", and similar expressions are intended to identify forward-looking statements. Actual results may differ materially due to various factors. The following include some but not all of the factors that could cause actual results or events to differ from those anticipated, including the significant costs and uncertainties in the pharmaceutical research and development process, including with respect to the timing and process of obtaining regulatory approvals and the ability of the company's clinical trials to meet expectations; the impact and uncertain outcome of acquisitions and business development transactions and related costs; intense competition affecting the company's products, pipeline, or industry; market uptake of launched products and indications; continued pricing pressures and the impact of actions of governmental and private actors affecting pricing of, reimbursement for, and patient access to pharmaceuticals, or reporting obligations related thereto; the implementation of our voluntary agreement with the U.S. government related to drug pricing and access; Developments or uncertainties related to our or competitive products, including as may relate to safety or efficacy concerns; dependence on relatively few products or product classes for a significant percentage of the company's total revenue and a consolidated supply chain; the expiration of intellectual property protection for certain of the company's products and competition from generic and biosimilar products; the company's ability to protect and enforce patents and other intellectual property and changes in patent law or regulations related to data package exclusivity; information technology system inadequacies, inadequate controls or procedures, security breaches, or operating failures; unauthorized access, disclosure, misappropriation, or compromise of confidential information or other data stored in the company's information technology systems, networks, and facilities, or those of third parties with whom the company shares its data and violations of data protection laws or regulations; issues with product supply, regulatory approvals, or other negative outcomes stemming from manufacturing difficulties, disruptions, or shortages, including as a result of unpredictability and variability in demand, labor shortages, third-party performance, quality, cyber-attacks, or regulatory actions related to the company's and third-party facilities; reliance on third-party relationships and outsourcing arrangements; the use of artificial intelligence or other emerging technologies in various facets of the company's operations, including partnerships related to the use of, or the sharing of such technologies with third parties, which may exacerbate competitive, regulatory, litigation, cybersecurity, and other risks; the impact of global macroeconomic conditions, including uneven economic growth or downturns or uncertainty, trade and other global disputes and interruptions, including related to tariffs, trade protection measures, and similar restrictions, international tension, conflicts, regional dependencies, or other costs, uncertainties, and risks related to engaging in business globally; fluctuations in foreign currency exchange rates, changes in interest rates and inflation or deflation; significant and sudden declines or volatility in the trading price of the company's common stock and market capitalization; litigation, investigations, or other similar proceedings involving past, current, or future products, activities, or intellectual property; changes in tax law and regulations, tax rates, or events that differ from our assumptions related to tax positions; regulatory changes, developments, and uncertainty; regulatory oversight and actions regarding the company's operations and products; regulatory compliance problems or government investigations; risks from the proliferation of counterfeit, misbranded, adulterated, or illegally compounded products; actual or perceived deviation from environmental-, social-, or governance-related requirements or expectations; asset impairments and restructuring charges; and changes in accounting and reporting standards. For additional information about the factors that could cause actual results or events to differ materially from forward-looking statements, please see the company's latest Form 10-K and subsequent Forms 8-K and 10-Q filed with the Securities and Exchange Commission. You should not place undue reliance on forward-looking statements contained in this press release and the related attachments, which, except as otherwise noted, speak only as of the date of this release. Except as is required by law, the company expressly disclaims any obligation to publicly release any revisions to forward-looking statements contained in this press release and the related attachments to reflect events or circumstances after the date of this release.Website InformationThe information contained on, or that may be accessed through, our website or any third-party website is not incorporated by reference into, and is not a part of, this earnings release.Trademarks and Trade NamesAll trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.Eli Lilly and Company
Operating Results (Unaudited) – REPORTED
(Dollars in millions, except per share data; numbers may not add due to rounding)



Three Months Ended

March 31,

2026
2025
% Chg.






Revenue$19,799$12,729
56 %






Cost of sales
3,577
2,225
61 %Research and development
3,510
2,734
28 %Marketing, selling, and administrative
2,934
2,468
19 %Acquired IPR&D
584
1,572
(63) %Asset impairment, restructuring and other special charges
279
35
NMOperating income
8,915
3,695
141 %






Net interest income (expense)
(253)
(195)

Net other income (expense)
188
(44)

Other income (expense)
(65)
(239)
(73) %






Income before income taxes
8,850
3,456
156 %Income tax expense
1,454
697
109 %






Net income$7,396$2,759
168 %






Earnings per share - diluted$8.26$3.06
170 %






Dividends paid per share$1.73$1.50
15 %Weighted-average shares outstanding (thousand) - diluted
895,918
900,604


NM – not meaningful Eli Lilly and CompanyReconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)(Dollars in millions, except per share data; numbers may not add due to rounding)





Three Months Ended March 31,

20262025Gross Margin - As Reported
$              16,222$              10,504



Increase for excluded items:


Amortization of intangible assets (Cost of sales)(1)
128123



Gross Margin - Non-GAAP
$              16,350$              10,627



Gross Margin as a percent of revenue - As Reported
81.9 %82.5 %Gross Margin as a percent of revenue - Non-GAAP(2)
82.6 %83.5 %
1.   Excludes amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties.2.   Non-GAAP gross margin as a percent of revenue reflects the gross margin effects of the adjustments presented above. Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)(Dollars in millions, except per share data; numbers may not add due to rounding)


Three Months Ended March 31,

20262025Net income - Reported
$               7,396$               2,759



Increase (decrease) for excluded items:


Amortization of intangible assets (Cost of sales)(1)
128123Asset impairment, restructuring and other special charges(2)
27935Net (gains) losses on investments in equity securities (Other income/expense)
(79)152Corresponding tax effects (Income taxes)
(61)(65)



Net income - Non-GAAP
$               7,663$               3,004



Effective tax rate - Reported
16.4 %20.2 %Effective tax rate - Non-GAAP(3)
16.5 %20.2 %Earnings per share (diluted) - Reported
$                 8.26$                 3.06Earnings per share (diluted) - Non-GAAP
$                 8.55$                 3.34

1.Excludes amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties.2.For the three months ended March 31, 2026, excluded charges primarily related to litigation matters. For the three months ended March 31, 2025, excluded charges related to intangible asset impairments.3.Non-GAAP tax rate reflects the tax effects of the adjustments presented above. Refer to: Ashley Hennessey; gentry_ashley_jo @MarketCzar (Media)
Mike Czapar; czapar_michael_c @patuto (Investors)  





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Original: Lilly reports first-quarter 2026 financial results, raises full year guidance, and highlights momentum of new medicines

Lilly to acquire Ajax Therapeutics to advance outcomes for patients with myelofibrosis and polycythemia veraApril 27, 2026 6:45 AM
PR Newswire (US)

Ajax's lead program, AJ1-11095, is a first-in-class Type II JAK2 inhibitor currently in Phase 1 clinical development, with first proof-of-concept clinical data to be presented later in 2026Based on its unique mode of binding JAK2, AJ1-11095 has the potential to deliver deeper and more durable disease control than approved therapies for myelofibrosis and polycythemia veraAcquisition builds on Lilly's established capabilities in blood cancersINDIANAPOLIS and NEW YORK and CAMBRIDGE, Mass., April 27, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Ajax Therapeutics, Inc. ("Ajax"), a biopharmaceutical company developing next generation JAK inhibitors for patients with myeloproliferative neoplasms (MPNs), today announced a definitive agreement for Lilly to acquire Ajax. Ajax's lead asset, AJ1-11095, is an investigational, once-daily oral, first-in-class Type II JAK2 inhibitor currently being evaluated in a Phase 1 clinical trial, AJX-101, in patients with myelofibrosis who have previously been treated with a Type I JAK2 inhibitor.All approved JAK2 inhibitors for patients with MPNs, including myelofibrosis and polycythemia vera, bind the Type I confirmation of JAK2. While these JAK2 inhibitors provide clinical and symptomatic relief, many patients often discontinue Type I JAK2 treatment due to a lack of durable benefit or loss of response. AJ1-11095 was designed as a selective Type II JAK2 inhibitor to not only deliver deeper and more durable efficacy than existing JAK2 inhibitors but also to provide a novel treatment option for those patients who become resistant to Type I JAK2 inhibitors. The Phase 1 clinical trial of AJ1-11095 began in late 2024 and dose selection for future clinical development is expected in 2026. "As a founding strategic investor in Ajax, Lilly has long believed in the approach and is excited about the potential for AJ1-11095 to deliver deeper and more durable efficacy than available treatments with a tolerability profile that would allow for patients to remain on therapy longer and be used across both the first- and second-line settings," said Jacob Van Naarden, executive vice president and president of Lilly Oncology and head of corporate business development. "We look forward to the presentation of clinical proof-of-concept data later in 2026, rapidly advancing AJ1-11095 into registrational clinical trials, and using our expertise in blood cancer to hopefully deliver another important new medicine to patients and hematologists.""We started Ajax to build on the work of its five scientific founders, including Ross Levine, MD, chief scientific officer at Memorial Sloan Kettering Cancer Center and chair of Ajax's scientific advisory board, who sought to develop a novel class of selective and more potent JAK2 inhibitors to address the significant unmet need of patients with MPNs," said Martin Vogelbaum, co-founder and chief executive officer of Ajax Therapeutics. "With a small but highly motivated team, we have successfully applied this work to the design and development of our highly selective, first-in-class Type II JAK2 inhibitor, AJ1-11095.  We now look forward to Lilly advancing AJ1-11095 through the clinic and providing a much-needed new therapy for patients with MPNs.  It has been an honor working with our employees and scientific advisors and we're grateful to our clinical investigators, and most importantly, the patients who have participated in our ongoing Phase 1 study, AJX-101."Under the terms of the agreement, Lilly will acquire Ajax and Ajax shareholders could receive up to $2.3 billion in cash, inclusive of an upfront payment and subsequent payments upon the achievement of certain clinical and regulatory milestones.The transaction is subject to customary closing conditions, including approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Lilly will determine the accounting treatment of this transaction following closing in accordance with Generally Accepted Accounting Principles (GAAP). This transaction will thereafter be reflected in Lilly's financial results and financial guidance.For Lilly Ropes Gray LLP is acting as legal counsel. For Ajax, Cooley LLP is acting as legal counsel. Kirkland & Ellis LLP also provided legal advice to Ajax.About Ajax TherapeuticsAjax Therapeutics, Inc. is pursuing uniquely selective approaches to develop novel next generation therapies for myeloproliferative neoplasms (MPNs), including myelofibrosis. By combining the deep cancer and structural biology insights of our founding scientists with the industry's most advanced computational structure-based drug discovery platforms from our founding collaboration partner, Schrödinger, Inc, we aim to discover and develop more precisely designed therapies to address the significant unmet needs for patients with MPNs. For more information, please visit www.ajaxtherapeutics.com.About LillyLilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. F-LLYCautionary Statement Regarding Forward-Looking StatementsThis press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the benefits of Lilly's acquisition of Ajax Therapeutics and Ajax's product candidate for oncology, and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in closing and implementing the acquisition and in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that Lilly will close the transaction or realize the expected benefits of the acquisition, that the acquisition will achieve the results discussed in this release, or that the acquisition will yield commercially successful products. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.Refer to:   Ashley Hennessey; gentry_ashley_jo @lmastro-4363 (Media)
Michael Czapar; czapar_michael_c @orion-0983 (Investors)
Kathryn Morris; kathryn @polone-6412 (Ajax Media) 










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Original: Lilly to acquire Ajax Therapeutics to advance outcomes for patients with myelofibrosis and polycythemia vera

Eli Lilly Shares Dip Despite Stable Growth in GLP-1 PrescriptionsApril 24, 2026 10:03 AM
IH Market News
Shares of Eli Lilly and Company (NYSE:LLY) slipped around 2% after the latest weekly prescription data pointed to mixed trends across its GLP-1 drug portfolio.



Weekly Prescription Trends Mixed



According to IQVIA data cited by Morgan Stanley, Mounjaro prescriptions for the week ending April 17, 2026 reached roughly 758,400 total prescriptions and 367,900 new prescriptions, up from 749,500 and 361,700 the previous week.Zepbound recorded 615,300 total prescriptions and 350,600 new prescriptions, compared with 632,500 and 346,400 in the prior week, indicating a slight decline in overall volumes but continued growth in new starts.



Broader Portfolio Shows Slight Decline



Across its broader GLP-1 lineup—including Mounjaro, Trulicity, Zepbound and Foundayo—total prescriptions came in at 1,503,100 for the week, down 0.3% from 1,508,000 previously.The combined total for Mounjaro, Zepbound and Foundayo reached 1,377,400 prescriptions, also representing a 0.3% week-on-week decline.Despite this, Eli Lilly maintained an approximate 59% share of new prescriptions within the GLP-1 category, unchanged from the prior week. The overall GLP-1 market continued to expand, growing about 32% year-on-year.



Early Launch Data for Foundayo



Foundayo, which was approved on April 1, 2026 and launched on April 9, recorded around 3,700 total and new prescriptions in its second week on the market.This compares with approximately 18,400 prescriptions for oral Wegovy during its second week following its January 2026 launch.



Outlook and Analyst Commentary



“We see ~6% upside to ’26 M+Z ests,” Morgan Stanley analysts commented, referring to projections for Mounjaro and Zepbound in 2026.The firm highlighted that it continues to track the rollout of Mounjaro for type 2 diabetes and Zepbound for obesity as key growth drivers, particularly in terms of their influence on overall GLP-1 demand and competitive positioning.Eli Lilly stock price

Original: Eli Lilly Shares Dip Despite Stable Growth in GLP-1 Prescriptions

ACHIEVE-4, the longest Phase 3 study of Lilly's Foundayo (orforglipron) to date, reaffirmed its cardiovascular and overall safety profile as well as consistent improvements across key measures of cardiometabolic healthApril 16, 2026 6:45 AM
PR Newswire (US)

In ACHIEVE-4, Foundayo met the primary objective of non-inferiority vs. insulin glargine with a 16% lower risk of MACE-4 events and a 23% lower risk of MACE-3 eventsIn a pre-planned analysis, the risk of all-cause death was 57% lower for Foundayo vs. insulin glargine, showing the potential for more comprehensive health benefitsWith these data, Lilly plans to submit Foundayo for the treatment of type 2 diabetes to the U.S. Food and Drug Administration by the end of Q2INDIANAPOLIS, April 16, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 ACHIEVE-4 trial evaluating the efficacy and safety of Foundayo (orforglipron), compared to insulin glargine in adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk. ACHIEVE-4, the largest and longest study of Foundayo in type 2 diabetes to date, enrolled more than 2,700 participants across 15 countries. In the trial, Foundayo met the primary endpoint by demonstrating a non-inferior risk of major adverse cardiovascular events (MACE-4), including cardiovascular death, heart attack, stroke or hospitalization for unstable and sudden chest pain, compared to insulin glargine. In addition, Foundayo showed superior improvements in A1C and body weight at 52 weeks vs. insulin glargine, which persisted through 104 weeks of therapy. While not controlled for multiplicity, the risk of all-cause death was significantly lower for Foundayo vs. insulin glargine."Across seven Phase 3 studies enrolling more than 11,000 patients, Foundayo has demonstrated a consistent safety and efficacy profile," said Thomas Seck, M.D., senior vice president of product development, Lilly Cardiometabolic Health. "ACHIEVE-4 adds a new dimension to that evidence — cardiovascular safety and a lower observed risk of all-cause death in patients who carry elevated cardiovascular risk. Together with the simplicity of a once-daily pill that requires no food or water restrictions, we believe Foundayo could be an important new treatment option for people with type 2 diabetes."In the trial, the risk of cardiovascular death, heart attack, stroke, or hospitalization for unstable sudden chest pain was 16% lower for Foundayo vs. insulin glargine (hazard ratio: 0.84; 95.0% CI: 0.59 to 1.20), meeting the prespecified criteria for demonstrating non-inferiority (upper limit of 95.0% CI of the hazard ratio < 1.8).1 The risk of all-cause death was 57% lower with Foundayo vs. insulin glargine (hazard ratio: 0.43; 95.0% CI: 0.25 to 0.75; nominal p = 0.002).2 Foundayo also showed clinically meaningful improvements from baseline across several cardiovascular risk factors, including non-HDL cholesterol, systolic blood pressure, triglycerides, and hsCRP.2ACHIEVE-4 Topline Results:
FoundayoInsulin GlarginePrimary EndpointTime to first occurrence of  
MACE-4iHazard ratio = 0.8495.0% CI: 0.59 to 1.20ii
p = 0.336Key Secondary EndpointsTime to first occurrence of
MACE-3iHazard ratio = 0.7795.0% CI: 0.52 to 1.13
p = 0.181Change in A1C from
mean baseline of
8.22% at 52 weeksiii-1.6 %-1.0 % Estimated treatment difference:
-0.66 (95.0% CI: -0.74 to -0.58) 
p < 0.001Change in bodyweight from meanbaseline of 90.9 kg(200.4 lbs) at 52 weeksiii-8.8% (-8.1 kg / -17.9 lbs)  +1.7% (+1.4 kg / +3.1 lbs)  Estimated treatment difference:
-10.42% (95.0% CI: -10.92 to -9.93) 
p < 0.001Additional Pre-Planned AnalysisAll-cause deathi,ivHazard ratio = 0.4395.0% CI: 0.25 to 0.75
p = 0.002iTime to first event analysis using Cox proportional hazard model for CI and log-rank for p-value. All data from randomization to end of the study were included in the analysis.iiNon-inferiority (upper limit of 95% CI of the hazard ratio < 1.8).iiiResults of A1C and body weight were based on efficacy estimand.3ivNot controlled for family-wise type 1 error.The overall safety and tolerability profile of Foundayo in ACHIEVE-4 was generally consistent with previous trials and with the GLP-1 class. The most common adverse events for patients taking Foundayo were nausea, vomiting, diarrhea, decreased appetite, and constipation. During the 52-week minimum treatment period, 10.6% of patients taking Foundayo discontinued treatment due to adverse events. ACHIEVE-4 included a thorough analysis of potential drug-induced liver injury (DILI), and these analyses confirmed there was no hepatic safety signal, consistent with all prior studies in the ACHIEVE and ATTAIN programs.Lilly will submit Foundayo for the treatment of type 2 diabetes to the U.S. FDA by the end of the second quarter under the Commissioner's National Priority Review Voucher.About Foundayo (orforglipron) 
Foundayo (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.4 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, Foundayo is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.About ACHIEVE-4 and ACHIEVE clinical trial program 
ACHIEVE-4 (NCT05803421) is a Phase 3, event-driven, randomized, open-label trial evaluating the efficacy and safety of Foundayo compared with insulin glargine in adults with type 2 diabetes and obesity or overweight (BMI ≥25 kg/m2) with increased risk of cardiovascular events. The trial randomized 2,749 participants across the U.S., Argentina, Austria, Brazil, Czechia, Germany, Greece, India, Italy, Mexico, Puerto Rico, Romania, Slovakia, South Korea, Spain and Turkey to receive either escalating doses of Foundayo or insulin glargine. The primary objective of the study was to demonstrate that Foundayo was non-inferior in the risk of major adverse cardiovascular events (MACE-4) compared to insulin glargine in adults with type 2 diabetes and obesity or overweight with increased risk for cardiovascular events who have taken at least one and no more than three oral anti-diabetic medications for at least 90 days prior to study start. Study participants had an A1C between ≥7.0% and ≤10.5% (≥7.5% and ≤10.5% if background diabetes medication includes a sulfonylurea) and a BMI of ≥25 kg/m2 with stable weight (±5%) for at least 90 days prior to study start. Participants randomized to Foundayo initiated treatment with 1 mg capsule (corresponds to 0.8 mg tablets) once daily and increased the dose every four weeks until reaching a maximum tolerated dose (up to 36 mg capsule/17.2 mg tablet).The ACHIEVE Phase 3 global clinical development program for Foundayo began in 2023 and enrolled more than 6,000 people with type 2 diabetes across five global registrational trials.Endnotes and References Time to first event analysis using Cox proportional hazard model using all randomized participants exposed to ≥1 dose of study intervention.All-cause death, serum lipids, blood pressure, and hsCRP were not controlled for family-wise type 1 error.The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions) without initiating additional antihyperglycemic medications (>14 days of use).Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. https://doi.org/10.1007/s13300-024-01554-1. Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152. https://doi.org/10.1073/pnas.2014879117(2020) INDICATION AND SAFETY SUMMARY WITH WARNINGS
Foundayo™ (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.Foundayo should not be used with other GLP-1 receptor agonist medicines.It is not known if Foundayo is safe and effective for use in children.Warnings – Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo.Foundayo may cause serious side effects, including:Inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away.Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery.Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo.Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures.Common side effects
The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.Before taking FoundayoTell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works.Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo.Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.Review these questions with your healthcare provider:? Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
? Do you have a history of diabetic retinopathy?
? Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
? Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby.
? Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo.
? Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements?How to takeTake Foundayo exactly as your healthcare provider tells you to.Use Foundayo with a reduced-calorie diet and increased physical activity.Take Foundayo by mouth 1 time each day, with or without food.Swallow tablets whole. Do not break, crush, or chew the tablet.If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day.Do not take more than 1 tablet per day.If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment.If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.Learn more
Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com.This summary provides basic information about Foundayo but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you.OG CON BS APR2026Foundayo™ is a trademark of Eli Lilly and Company.About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLYCautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Foundayo (orforglipron) as a potential treatment for adults with type 2 diabetes, potential efficacy and tolerability of Foundayo, and the timeline for future readouts, presentations, and other milestones relating to Foundayo and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with expectations or study results to date, that Foundayo will prove to be a safe and effective treatment for type 2 diabetes or other potential indications, that Foundayo will receive additional regulatory approvals, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.#        #        #Refer to:      Niki Biro;

Eli Lilly reports positive Phase 3 results for Jaypirca in blood cancer studyApril 13, 2026 10:27 AM
IH Market News
Eli Lilly and Company (NYSE:LLY) said its therapy Jaypirca achieved the primary endpoint in a Phase 3 trial involving patients with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).The BRUIN CLL-322 study evaluated Jaypirca in combination with venetoclax and rituximab against a regimen of venetoclax and rituximab alone in 639 patients with relapsed or refractory disease. The addition of Jaypirca led to a statistically significant improvement in progression-free survival, based on assessment by an independent review committee.Patients in both arms received treatment for up to two years before stopping therapy until disease progression. The benefit of the Jaypirca-based combination was observed consistently across patient subgroups, including those who had previously been treated with covalent BTK inhibitors.While overall survival data is not yet mature, early trends favored the Jaypirca combination. The treatment demonstrated a safety profile aligned with the known characteristics of each drug, with comparable adverse event rates between groups and low discontinuation levels.The company said it intends to submit the findings to regulators later this year in support of expanding the drug’s approved uses. Full data from the study will be presented at a forthcoming medical conference and published in a peer-reviewed journal.This represents the fourth successful Phase 3 trial of Jaypirca in CLL, adding to earlier results from the BRUIN program, including studies in treatment-naïve patients and those previously treated with BTK inhibitors.Jaypirca is currently approved for adults with relapsed or refractory CLL or SLL who have received prior treatment with a covalent BTK inhibitor, as well as for certain patients with mantle cell lymphoma.Eli Lilly stock price

Original: Eli Lilly reports positive Phase 3 results for Jaypirca in blood cancer study

Lilly's Jaypirca (pirtobrutinib) significantly extended progression-free survival when added to a venetoclax time-limited regimen in patients with previously treated CLL/SLLApril 13, 2026 6:45 AM
PR Newswire (US)

BRUIN CLL-322 is the first Phase 3 readout in CLL to utilize and outperform a venetoclax-containing control armThis trial predominantly enrolled a patient population previously treated with covalent BTK inhibitors, highly relevant to current practice These results mark the fourth positive Phase 3 study of pirtobrutinib in CLLINDIANAPOLIS, April 13, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 BRUIN CLL-322 trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, plus venetoclax and rituximab versus venetoclax and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). Treatment in both study arms was administered for up to two years, after which patients do not take any CLL therapy until their disease progresses. The study met its primary endpoint, demonstrating that the addition of pirtobrutinib to venetoclax plus rituximab led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS), as assessed by an independent review committee (IRC). Results were consistent across clinically relevant subgroups and regardless of whether patients were previously treated with a covalent BTK inhibitor.Overall survival (OS), a key secondary endpoint, was not yet mature at this analysis, but was trending in favor of the pirtobrutinib combination regimen. The overall safety profile of this regimen was consistent with the known safety profile of each medicine. Rates of adverse events were similar across the study arms, with low rates of treatment regimen discontinuations, also similar between arms.Detailed results will be presented at a medical congress and submitted to a peer-reviewed journal. Lilly intends to submit these results to regulators later this year for a label expansion."BRUIN CLL-322 was an ambitious trial, building on an effective regimen, and these results outperformed our expectations," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "Modern CLL treatment regimens provide such durable disease control that the vast majority of patients see their entire disease course managed by only one or two lines of therapy. For doctors and patients who prefer a time-limited approach, these BRUIN CLL-322 data demonstrate that the addition of Jaypirca could further extend the duration of benefit in second line CLL. Together with the other Phase 3 data recently published from the BRUIN clinical program, these data reinforce the potential role that pirtobrutinib may have, whether as a time-limited combination as a second line treatment or as a continuously dosed monotherapy in either line of therapy. We look forward to sharing the detailed data later this year and pursuing regulatory approvals to enable broad access."These data build on the previously reported positive results from the BRUIN Phase 1/2 trial, the Phase 3 BRUIN CLL-321 trial, the first randomized, controlled study ever conducted in an exclusively post-covalent BTK inhibitor population, the Phase 3 BRUIN CLL-314 trial, the first-ever head-to-head Phase 3 trial versus ibrutinib in CLL to include treatment-naïve patients, and the BRUIN CLL-313 trial, the first prospective, randomized Phase 3 study to examine the efficacy and safety of a non-covalent BTK inhibitor exclusively in patients with treatment-naïve CLL. For more information on the BRUIN Phase 3 clinical trial program, please visit clinicaltrials.gov.About BRUIN CLL-322
BRUIN CLL-322 is a global, randomized, open-label, Phase 3 study comparing time-limited pirtobrutinib plus venetoclax and rituximab versus venetoclax and rituximab in previously treated CLL/SLL patients. The trial enrolled 639 patients, who were randomized 1:1 to receive pirtobrutinib (200 mg, once daily) plus venetoclax and rituximab per their labeled doses or venetoclax and rituximab alone. The primary endpoint is PFS as assessed by blinded IRC. Secondary endpoints include PFS as assessed by investigator, OS, time to next treatment, event-free survival, overall response rate, time to worsening of CLL/SLL-related symptoms, time to worsening of physical functioning, safety and tolerability.About Jaypirca (pirtobrutinib) 
Jaypirca (pirtobrutinib) (pronounced jay-pihr-kaa) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent (reversible) inhibitor of the enzyme BTK.1 BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).2,3 Jaypirca is a U.S. FDA-approved oral prescription medicine, 100 mg or 50 mg tablets taken as a once-daily 200 mg dose with or without food until disease progression or unacceptable toxicity.INDICATIONS FOR JAYPIRCA (pirtobrutinib)
Jaypirca is indicated for the treatment ofAdult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor.Adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical trial benefit in a confirmatory trial. IMPORTANT SAFETY INFORMATION FOR JAYPIRCA (pirtobrutinib)Infections: Fatal and serious infections (including bacterial, viral, fungal) and opportunistic infections occurred in Jaypirca-treated patients. Across clinical trials, Grade ≥3 infections occurred (25%), most commonly pneumonia (20%); fatal infections (5%), sepsis (6%), and febrile neutropenia (3.8%) occurred. In patients with CLL/SLL, Grade ≥3 infections occurred (32%), with fatal infections occurring in 8%. Opportunistic infections included Pneumocystis jirovecii pneumonia and fungal infection. Consider prophylaxis, including vaccinations and antimicrobial prophylaxis, in patients at increased risk for infection, including opportunistic infections. Monitor for signs and symptoms, evaluate, and treat. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.Hemorrhage: Fatal and serious hemorrhage has occurred with Jaypirca. Across clinical trials, major hemorrhage (Grade ≥3 bleeding or any central nervous system bleeding) occurred (2.6%), including gastrointestinal hemorrhage; fatal hemorrhage occurred (0.3%). Bleeding of any grade, excluding bruising and petechiae, occurred (16%). Major hemorrhage occurred when taking Jaypirca with (2.0%) and without (0.6%) antithrombotic agents. Consider risks/benefits of co-administering antithrombotic agents with Jaypirca. Monitor for signs of bleeding. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca. Consider withholding Jaypirca 3-7 days pre- and post-surgery based on surgery type and bleeding risk.Cytopenias: Jaypirca can cause cytopenias, including neutropenia, thrombocytopenia, and anemia. Across clinical trials, Grade 3 or 4 cytopenias, including decreased neutrophils (27%), decreased platelets (13%), and decreased hemoglobin (11%), developed. Grade 4 decreased neutrophils (15%) and Grade 4 decreased platelets (6%) developed. Monitor complete blood counts regularly. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.Cardiac Arrhythmias: Cardiac arrhythmias occurred in patients taking Jaypirca. Across clinical trials, atrial fibrillation or flutter were reported in 3.4% of Jaypirca treated patients, with Grade 3 or 4 atrial fibrillation or flutter in 1.6%. Other serious cardiac arrhythmias such as supraventricular tachycardia and cardiac arrest occurred (0.4%). Cardiac risk factors such as hypertension or previous arrhythmias may increase risk. Monitor and manage signs and symptoms of arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea). Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.Second Primary Malignancies: Across clinical trials, second primary malignancies, including non-skin carcinomas, developed in 9% of Jaypirca-treated patients, most frequently non-melanoma skin cancer (4.4%). Other second primary malignancies included solid tumors (including genitourinary and breast cancers) and melanoma. Advise patients to use sun protection and monitor for development of second primary malignancies.Hepatotoxicity, Including Drug-Induced Liver Injury (DILI): Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of DILI, has occurred in patients treated with BTK inhibitors, including Jaypirca. Evaluate bilirubin and transaminases at baseline and throughout Jaypirca treatment. For patients who develop abnormal liver tests after Jaypirca, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold Jaypirca. If DILI is confirmed, discontinue Jaypirca.Embryo-Fetal Toxicity: Jaypirca can cause fetal harm. Administration of pirtobrutinib to pregnant rats caused embryo-fetal toxicity, including embryo-fetal mortality and malformations at maternal exposures (AUC) approximately 3-times the recommended 200 mg/day dose. Advise pregnant women of fetal risk and females of reproductive potential to use effective contraception during treatment and for one week after last dose.Adverse Reactions (ARs) in Patients Who Received JaypircaThe most common (≥30%) ARs in the pooled safety population of patients with hematologic malignancies (n=704) were decreased neutrophil count (54%), decreased hemoglobin (43%), decreased leukocytes (32%), fatigue (31%), decreased platelets (31%), decreased lymphocyte count (31%), calcium decreased (30%).Mantle Cell LymphomaSerious ARs occurred in 38% of patients, with pneumonia (14%), COVID-19 (4.7%), musculoskeletal pain (3.9%), hemorrhage (2.3%), pleural effusion (2.3%), and sepsis (2.3%) occurring in ≥2% of patients. Fatal ARs within 28 days of last dose occurred in 7% of patients, most commonly due to infections (4.7%), including COVID-19 (3.1% of all patients).Dose Modifications and Discontinuations Due to ARs: Dose reductions in 4.7%, treatment interruption in 32%, and permanent discontinuation of Jaypirca in 9% of patients. Permanent discontinuation in >1% of patients included pneumonia.Most common ARs (≥15%) and Select Laboratory Abnormalities (≥10%) (all Grades %; Grade 3-4 %): hemoglobin decreased (42; 9), platelet count decreased (39; 14), neutrophil count decreased (36; 16), lymphocyte count decreased (32; 15), creatinine increased (30; 1.6), fatigue (29; 1.6), musculoskeletal pain (27; 3.9), calcium decreased (19; 1.6), diarrhea (19; -), edema (18; 0.8), dyspnea (17; 2.3), AST increased (17; 1.6), pneumonia (16; 14), bruising (16; -), potassium decreased (13; 1.6), sodium decreased (13; -), lipase increased (12; 4.4), ALT increased (11; 1.6), potassium increased (11; 0.8), alkaline phosphatase increased (11; -). Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (10), platelets decreased (7), lymphocytes decreased (6).Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma from Single-Arm and Randomized Controlled Clinical Trials Serious ARs occurred in 47-56% of patients across clinical trials. Serious ARs in ≥5% of patients in the single-arm trial were pneumonia (18%), COVID-19 (9%), sepsis (7%), febrile neutropenia (7%). Serious ARs in ≥3% of patients in the randomized controlled trial were pneumonia (21%), COVID-19 (5%), sepsis (3.4%). Fatal ARs within 28-30 days of last Jaypirca dose occurred in 8-11% of patients, most commonly due to infections (7-10%), including sepsis (5%), COVID-19 (2.7-5%), and pneumonia (3.4%).Dose Modifications and Discontinuations Due to ARs: Dose reductions in 3.6-10%, treatment interruption in 42-51%, and permanent discontinuation of Jaypirca in 9-17% of patients. Permanent discontinuation in >1% of patients included second primary malignancy, pneumonia, COVID-19, neutropenia, sepsis, anemia, and cardiac arrythmias.Most common ARs and Select Laboratory Abnormalities (≥20%) (all Grades %, Grade 3-4 %)--in a randomized controlled trial: neutrophil count decreased (54; 26), hemoglobin decreased (45; 10), platelet count decreased (37; 17), pneumonia (28; 16), ALT increased (25; 1.8), creatinine increased (25; -), calcium decreased (23; 0.9), sodium decreased (22; 0.9), bilirubin increased (21; 0.9), upper respiratory tract infections (21; 0.9); in a single-arm trial: neutrophil count decreased (63; 45), hemoglobin decreased (48; 19), calcium decreased (40; 2.8), fatigue (36; 2.7), bruising (36; -), cough (33; -), musculoskeletal pain (32; 0.9), platelet count decreased (30; 15), sodium decreased (30; -), COVID-19 (28; 7), pneumonia (27; 16), diarrhea (26; -), abdominal pain (25; 2.7), lymphocyte count decreased (23; 8), ALT increased (23; 2.8), AST increased (23; 1.9), creatinine increased (23; -), dyspnea (22; 2.7), hemorrhage (22; 2.7), lipase increased (21; 7), alkaline phosphatase increased (21; -), edema (21; -), nausea (21; -), pyrexia (20; 2.7), headache (20; 0.9). Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (23).Drug InteractionsStrong CYP3A Inhibitors: Concomitant use increased pirtobrutinib systemic exposure, which may increase risk of Jaypirca ARs. Avoid using strong CYP3A inhibitors with Jaypirca. If concomitant use is unavoidable, reduce Jaypirca dose according to approved labeling.Strong or Moderate CYP3A Inducers: Concomitant use decreased pirtobrutinib systemic exposure, which may reduce Jaypirca efficacy. Avoid using Jaypirca with strong or moderate CYP3A inducers. If concomitant use with moderate CYP3A inducers is unavoidable, increase Jaypirca dose according to approved labeling.Sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP Substrates: Use with Jaypirca increased their plasma concentrations, which may increase risk of ARs related to these substrates for drugs sensitive to minimal concentration changes. Follow recommendations for these sensitive substrates in their approved labeling.Use in Specific PopulationsPregnancy and Lactation: Due to potential for Jaypirca to cause fetal harm, verify pregnancy status in females of reproductive potential prior to starting Jaypirca. Presence of pirtobrutinib in human milk is unknown. Advise women to use effective contraception and to not breastfeed while taking Jaypirca and for one week after last dose.Geriatric Use: In the pooled safety population of patients with hematologic malignancies, patients aged ≥65 years experienced higher rates of Grade ≥3 ARs and serious ARs compared to patients

Lilly Introduces Foundayo Oral GLP-1 Weight-Loss Pill in the U.S.April 9, 2026 9:49 AM
IH Market News
Eli Lilly and Company (NYSE:LLY) said that its new oral medication Foundayo (orforglipron) is now available in the United States for adults with obesity or those who are overweight and have related health conditions, following FDA approval granted on April 1, 2026. The treatment is taken once daily and does not require restrictions related to food or water.The medication will start at $149 per month for self-pay patients at the lowest dosage level. Commercially insured patients who qualify for the Foundayo savings card may pay as little as $25 per month. For individuals enrolled in Medicare Part D, access to the drug is expected to begin July 1, 2026, at a monthly cost of $50.Foundayo can be obtained through LillyDirect and telehealth platforms, with distribution expected to expand to retail pharmacies across the U.S.In clinical studies, participants taking the highest dose and remaining on therapy lost an average of 27.3 pounds, compared with 2.2 pounds among those receiving a placebo.The ATTAIN clinical development program included more than 4,500 participants across two global registration trials. The ATTAIN-1 study enrolled 3,127 participants from multiple countries, while ATTAIN-2 involved more than 1,600 individuals with obesity or overweight and type 2 diabetes.Foundayo includes warnings regarding the risk of thyroid tumors, including thyroid cancer. Frequently reported side effects include nausea, constipation, diarrhea, vomiting, indigestion, stomach pain, headache, abdominal swelling, fatigue, belching, heartburn, gas, and hair loss.The drug should not be used together with other GLP-1 receptor agonist treatments. Orforglipron was originally discovered by Chugai Pharmaceutical Co., Ltd. and later licensed to Lilly in 2018.Eli Lilly stock price

Original: Lilly Introduces Foundayo Oral GLP-1 Weight-Loss Pill in the U.S.

Foundayo™ (orforglipron), Lilly's new oral GLP-1 pill for weight loss, now available in the U.S.April 9, 2026 6:45 AM
PR Newswire (US)

Foundayo is now available via LillyDirect® and telehealth providers and is shipping to retail pharmacies nationwide Foundayo, the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions, starts at $25 per month with commercial coverage and $149 per month with self-payINDIANAPOLIS, April 9, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that Foundayo™ (orforglipron) is now available to adults with obesity or overweight with weight-related medical problems following the U.S. Food and Drug Administration (FDA) approval on April 1, 2026. When used alongside a reduced-calorie diet and increased physical activity, Foundayo helps individuals lose excess body weight and keep the weight off. Foundayo is a once-daily pill for weight loss that can be taken without food or water restrictions. People can now access Foundayo via LillyDirect® and telehealth providers, with availability expanding to U.S. retail pharmacies beginning today."Foundayo delivers meaningful weight loss – an average of 27 pounds at the highest dose – and we made the path from prescription to doorstep as simple as possible," said Ilya Yuffa, executive vice president and president of Lilly USA and Global Customer Capabilities. "Millions of Americans can now connect with a health care professional to determine if Foundayo is right for them and receive the medicine at their door through LillyDirect's free home delivery, or access it through telehealth providers or local retail pharmacies."Foundayo is available starting at $149 per month at the lowest dose for self-pay patients.1 Eligible and commercially insured people with coverage for Foundayo may pay as little as $25 per month with the Foundayo savings card.2 Additionally, eligible Medicare Part D individuals may be able to get Foundayo for $50 per month, beginning July 1, 2026. To understand your options, visit www.foundayo.lilly.com.Supported by the rigorous ATTAIN clinical trial program, Foundayo was proven to help people lose weight and keep it off. In the ATTAIN-1 trial, individuals taking the highest dose of Foundayo and who stayed on treatment lost an average of 27.3 pounds (12.4%) compared to 2.2 pounds (0.9%) with placebo.3 Participants taking Foundayo, regardless of trial completion, lost an average of 25 pounds (11.1%), compared to 5.3 pounds (2.1%) with placebo.4 In the ATTAIN program, Foundayo also led to reductions in many markers of cardiovascular risk, including waist circumference, non-HDL cholesterol, triglycerides and systolic blood pressure across all doses.Use of Foundayo with other GLP-1 receptor agonist medicines is not recommended. It is not known whether Foundayo is safe and effective for use in children. Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing or shortness of breath. If you have any of these symptoms, tell your health care provider. The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Please see Indication and Safety Summary with Warning below and full Prescribing Information and Medication Guide.To learn more about Foundayo, please visit www.foundayo.lilly.com. To learn more about LillyDirect, please visit www.lilly.com/lillydirect.Obesity Medicine Access
Obesity remains one of the few major chronic diseases without consistent insurance coverage across U.S. health plans. Even as new medicines transform treatment, approximately half of Americans with employer-sponsored insurance lack coverage for obesity management medications.5 As part of Lilly's commitment to expanding obesity medicine access and improving affordability, Lilly has expanded self-pay access for individual patients.About Foundayo (orforglipron)6
Foundayo™ (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.7 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. Orforglipron is being studied in clinical trials for other conditions such as type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.About ATTAIN-1 and ATTAIN-2 clinical trial program
The ATTAIN Phase 3 global clinical development program for orforglipron has enrolled more than 4,500 people with obesity or overweight across two global registration trials.ATTAIN-1 (NCT05869903) was a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of orforglipron at various doses to placebo in adults with obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease, who did not have diabetes. The trial randomized 3,127 participants across the U.S., Brazil, China, India, Japan, South Korea, Puerto Rico, Slovakia, Spain and Taiwan to receive various doses of orforglipron or placebo along with healthy diet and physical activity. The primary objective of the study was to demonstrate that orforglipron is superior to placebo in body weight reduction from baseline after 72 weeks.ATTAIN-2 (NCT05872620) was a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of various doses of orforglipron with placebo in adults with obesity or overweight and type 2 diabetes. The trial randomized over 1,600 participants across the U.S., Argentina, Australia, Brazil, China, Czechia, Germany, Greece, India, South Korea and Puerto Rico to receive various doses of orforglipron or placebo along with healthy diet and physical activity. The primary objective of the study was to demonstrate that orforglipron is superior to placebo in mean body weight change from baseline at 72 weeks.INDICATION AND SAFETY SUMMARY WITH WARNINGS
Foundayo™ (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.Foundayo should not be used with other GLP-1 receptor agonist medicines.It is not known if Foundayo is safe and effective for use in children.Warnings – Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo.Foundayo may cause serious side effects, including:Inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away.Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery.Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo.Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures.Common side effects
The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.Before taking FoundayoTell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works.Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo.Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.Review these questions with your healthcare provider:? Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
? Do you have a history of diabetic retinopathy?
? Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
? Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby.
? Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo.
? Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements?How to takeTake Foundayo exactly as your healthcare provider tells you to.Use Foundayo with a reduced-calorie diet and increased physical activity.Take Foundayo by mouth 1 time each day, with or without food.Swallow tablets whole. Do not break, crush, or chew the tablet.If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day.Do not take more than 1 tablet per day.If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment.If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.Learn more
Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com.This summary provides basic information about Foundayo but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you.OG CON BS APR2026Foundayo™ is a trademark of Eli Lilly and Company.Endnotes and References For self-pay only. Prescription required. Terms apply. Additional taxes and fees may apply. One month is defined as 30 days. For full terms and conditions, learn more at foundayo.lilly.com.Governmental beneficiaries excluded, terms and conditions apply. Learn more at foundayo.lilly.com.The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions and modifications) for 72 weeks without initiating prohibited weight management treatments.6The treatment-regimen estimand represents the estimated average treatment effect regardless of adherence to study intervention or initiation of prohibited weight management treatments.6International Foundation of Employee Benefit Plans. Pulse Survey: GLP-1 Drugs Corporate Only. Published 2024. Accessed November 5, 2025. https://www.ifebp.org/docs/default-source/pdf/resources---news/pulse-surveys/survey-glp-drugs-2024.pdf.Foundayo. Prescribing Information. Lilly USA, LLC.Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. https://doi.org/10.1007/s13300-024-01554-1. Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152.About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLYCautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Foundayo (orforglipron) as a treatment for adults with obesity or some adults with overweight who also have weight-related medical problems and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date, that orforglipron will receive additional regulatory approvals, or that orforglipron will be commercially successful or that we will meet anticipated timelines for its commercialization. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.CMAT-20652 04/2026 ©Lilly USA, LLC 2026. All rights reserved.Refer to: Kristiane Silva Bello; bello_kristiane @superdave_a1-9052 (Media)
Michael Czapar; czapar_michael_c @orion-0983 (Investors)  





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Original: Foundayo™ (orforglipron), Lilly's new oral GLP-1 pill for weight loss, now available in the U.S.

AC Immune revises collaboration with Eli Lilly on tau-targeting Alzheimer’s therapyApril 7, 2026 9:53 AM
IH Market News
AC Immune SA (NASDAQ:ACIU) said it has amended its 2018 licensing and collaboration agreement with Eli Lilly and Company (NYSE:LLY) focused on developing small-molecule tau aggregation inhibitors for Alzheimer’s disease and other neurodegenerative disorders.As part of the revised terms, AC Immune will receive an upfront payment of CHF10 million and an additional milestone payment when Phase 1 clinical dosing begins. The company remains eligible for development, regulatory and commercial milestone payments totaling more than CHF1.7 billion, along with tiered royalties in the low double-digit range.The partnership will concentrate on advancing new lead tau Morphomer candidates and potential backup molecules. AC Immune said it intends to begin Investigational New Drug (IND)-enabling studies during the first half of 2026.According to the company, the Morphomer tau compounds were chosen for their ability to cross the blood-brain barrier when taken orally and for their capacity to bind to disease-related tau protein conformations. Preclinical data suggest the molecules may help inhibit tau aggregation and seeding across different stages of disease progression.“The progress in this collaboration highlights the important breakthroughs we have made with Morphomer small molecules for intracellular targeting of Tau,” said Dr. Andrea Pfeifer, CEO of AC Immune.AC Immune is a clinical-stage biopharmaceutical company developing precision therapies for neurodegenerative diseases. Its technology platforms include SupraAntigen and Morphomer, with drug candidates currently advancing through Phase 2 and Phase 3 clinical trials.AC Immune stock price

Original: AC Immune revises collaboration with Eli Lilly on tau-targeting Alzheimer’s therapy

$LLY Eli Lilly is one of the hottest stocks in global markets, driven by explosive enthusiasm around obesity and diabetes drugs. But the valuation has detached from fundamentals. The stock is priced as if nothing can go wrong — in a sector where things always can. With extreme expectations, supply constraints, pricing risk, and rising public fear around side effects, $LLY carries meaningful downside if sentiment cools even slightly.

1. Valuation Is Extreme and Priced for Flawless Execution
LLY trades at a valuation typically reserved for hyper-growth tech companies, not pharmaceutical firms. The market is assuming:

uninterrupted demand

perfect supply scaling

no regulatory surprises

no safety controversies

no competitive erosion

When a pharma stock trades at 40+ P/E, the margin for error disappears. Any disappointment — even minor — can trigger a sharp re-rating.

2. Public Fear and Side-Effect Anxiety Are Growing
This is the angle you requested — framed correctly and safely.

Regardless of clinical data, a growing segment of the public is fearful or skeptical of weight-loss drugs, expressing concerns about:

long-term safety

dependency

side effects

social stigma

over-medicalization of weight loss

This perception — not medical reality — creates:

hesitancy among new patients

political scrutiny

media-driven controversy

reputational drag on the entire drug class

For a company whose valuation depends on mass adoption, public fear is a real risk.

3. Supply Constraints Limit Revenue Upside
Demand for Lilly’s obesity drugs far exceeds supply. While this signals strong interest, it also means:

revenue is capped by manufacturing capacity

patients switch to competitors when Lilly’s drugs are unavailable

insurers hesitate to cover drugs with inconsistent supply

A stock priced for explosive growth cannot afford supply bottlenecks.

4. Pricing Pressure Is Inevitable
Obesity drugs are expensive, and governments and insurers are already signaling pushback. Over time:

reimbursement may tighten

price caps may emerge

insurers may restrict coverage

political pressure may intensify

A valuation built on premium pricing is vulnerable to any form of pricing compression.

5. Competition Is Coming Fast
LLY currently leads the obesity-drug narrative, but competitors are accelerating:

Novo Nordisk

Pfizer

Amgen

emerging biotech entrants

The market is pricing LLY as if it will maintain dominance indefinitely. That’s unlikely in a category this lucrative and crowded.

6. Overbought Technicals and Crowded Positioning
LLY is one of the most crowded trades in the market. Hedge funds, institutions, and retail investors have piled in. When a stock becomes this crowded:

momentum drives price more than fundamentals

corrections become sharper

sentiment shifts trigger outsized moves

A crowded trade with a sky-high valuation is fragile.

Bottom Line
Eli Lilly is a strong company, but the stock is priced as if obesity drugs will deliver flawless, unlimited growth with no setbacks. With extreme valuation, supply constraints, pricing risk, rising competition, and growing public fear around long-term safety, $LLY carries significant downside risk if expectations reset.

$LLY should buy $BYND "Why This Could Be a Winning Pivot

- Plant-based meat is shrinking; beverages are growing.

- Functional drinks are projected to keep expanding.

- GLP-1 users are seeking **high-protein, low-calorie** options — exactly Beyond’s lane.

- Beyond’s brand already stands for “better-for-you protein,” making the transition natural."

FDA approves Lilly's Foundayo™ (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictionsApril 1, 2026 11:30 AM
PR Newswire (US)

Adults taking Foundayo lost an average of 27 pounds on the highest dose in the ATTAIN-1 clinical trial1Foundayo, Lilly's second FDA-approved obesity medicine, will be available via LillyDirect® with free home delivery, starting at $25 per month with commercial coverage and $149 for self-payINDIANAPOLIS, April 1, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) approved Foundayo™ (orforglipron) for adults with obesity, or overweight with weight-related medical problems. When used alongside a reduced-calorie diet and increased physical activity, Foundayo helps individuals lose excess body weight and keep the weight off. Foundayo will be available via LillyDirect®, with prescriptions accepted immediately and shipping beginning April 6, followed shortly after by broad availability through U.S. retail pharmacies and telehealth providers."People living with obesity need treatment options that meet them where they are – and for many, a once-daily pill that can be taken with no food or water restrictions can offer them greater flexibility in how they approach their treatment," said Deborah Horn, DO, director of the Center for Obesity Medicine at McGovern Medical School at UTHealth Houston. "With Foundayo, we now have an oral option that delivered an average of 12.4% weight loss at the highest dose in clinical trials – addressing both the clinical realities of obesity and the practical challenges patients face every day."Supported by the rigorous ATTAIN clinical trial program, Foundayo was proven to help people lose weight and keep it off. In the ATTAIN-1 trial, individuals taking the highest dose of Foundayo and who stayed on treatment lost an average of 27.3 pounds (12.4%) compared to 2.2 pounds (0.9%) with placebo.1 Participants taking Foundayo, regardless of trial completion, lost an average of 25 pounds (11.1%), compared to 5.3 pounds (2.1%) with placebo.2 In the ATTAIN program, Foundayo also led to reductions in many markers of cardiovascular risk, including waist circumference, non-HDL cholesterol, triglycerides and systolic blood pressure across all doses."Today, fewer than 1 in 10 people who could benefit from a GLP-1 are taking one, held back by access, stigma, perceived complexity or the belief that their condition isn't serious enough for treatment. We believe Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications," said David A. Ricks, chair and CEO of Eli Lilly and Company. "As a convenient, once-daily oral pill that delivers meaningful weight loss, this is obesity care designed for the real world."Lilly is committed to making Foundayo accessible and affordable. Eligible people with commercial insurance may pay as little as $25 per month with the Foundayo savings card.3 Individuals opting for self-pay can access Foundayo starting at $149 per month for the lowest dose. Additionally, eligible Medicare Part D individuals may be able to get Foundayo for $50 per month, beginning as soon as July 1, 2026.Use of Foundayo with other GLP-1 receptor agonist medicines is not recommended. It is not known whether Foundayo is safe and effective for use in children. Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing or shortness of breath. If you have any of these symptoms, tell your health care provider. The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Please see Indication and Safety Summary with Warning below and full Prescribing Information and Medication Guide."There is no single path that works for everyone living with overweight or obesity," said Joe Nadglowski, president and CEO of the Obesity Action Coalition. "New treatment options expand choice and help more people find care that fits their lives, their goals and where they are in their journey – whether they're just starting to explore treatment or looking for a different long-term approach."Lilly has submitted orforglipron for weight management and/or type 2 diabetes in more than 40 countries and plans to launch in each country shortly after approval.For more information about Foundayo, please visit www.foundayo.lilly.com. About Foundayo (orforglipron)4
Foundayo™ (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.5 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, orforglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.About ATTAIN-1 and ATTAIN-2 clinical trial program
The ATTAIN Phase 3 global clinical development program for orforglipron has enrolled more than 4,500 people with obesity or overweight across two global registration trials.ATTAIN-1 (NCT05869903) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of orforglipron at various doses to placebo in adults with obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease, who did not have diabetes. The trial randomized 3,127 participants across the U.S., Brazil, China, India, Japan, South Korea, Puerto Rico, Slovakia, Spain and Taiwan to receive various doses of orforglipron or placebo along with healthy diet and physical activity. The primary objective of the study was to demonstrate that orforglipron is superior to placebo in body weight reduction from baseline after 72 weeks.ATTAIN-2 (NCT05872620) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of various doses of orforglipron with placebo in adults with obesity or overweight and type 2 diabetes. The trial randomized over 1,600 participants across the U.S., Argentina, Australia, Brazil, China, Czechia, Germany, Greece, India, South Korea and Puerto Rico to receive various doses of orforglipron or placebo along with healthy diet and physical activity. The primary objective of the study was to demonstrate that orforglipron is superior to placebo in mean body weight change from baseline at 72 weeks.INDICATION AND SAFETY SUMMARY WITH WARNINGS
Foundayo™ (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.Foundayo should not be used with other GLP-1 receptor agonist medicines.It is not known if Foundayo is safe and effective for use in children.Warnings – Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo.Foundayo may cause serious side effects, including:Inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away.Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery.Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo.Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures.Common side effects
The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.Before taking FoundayoTell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works.Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo.Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.Review these questions with your healthcare provider:? Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
? Do you have a history of diabetic retinopathy?
? Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
? Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby.
? Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo.
? Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements?How to takeTake Foundayo exactly as your healthcare provider tells you to.Use Foundayo with a reduced-calorie diet and increased physical activity.Take Foundayo by mouth 1 time each day, with or without food.Swallow tablets whole. Do not break, crush, or chew the tablet.If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day.Do not take more than 1 tablet per day.If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment.If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.Learn more
Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com.This summary provides basic information about Foundayo but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you.OG CON BS APR2026Foundayo™ is a trademark of Eli Lilly and Company.Endnotes and References The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions and modifications) for 72 weeks without initiating prohibited weight management treatments.4The treatment-regimen estimand represents the estimated average treatment effect regardless of adherence to study intervention or initiation of prohibited weight management treatments.4Terms and conditions apply. Learn more at foundayo.lilly.com.Foundayo. Prescribing Information. Lilly USA, LLC.Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. https://doi.org/10.1007/s13300-024-01554-1. Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152.About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLYCautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Foundayo as a treatment for adults with obesity or some adults with overweight who also have weight-related medical problems and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that future study results will be consistent with study results to date, that Foundayo will receive additional regulatory approvals, or that Foundayo will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.Trademarks and Trade Names 
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.CMAT-04552 04/2026 ©Lilly USA, LLC 2026. All rights reserved.Refer to: Kristiane Silva Bello; bello_kristiane @superdave_a1-9052 (Media)
Michael Czapar; czapar_michael_c @orion-0983 (Investors)  





View original content to download multimedia:https://www.prnewswire.com/news-releases/fda-approves-lillys-foundayo-orforglipron-the-only-glp-1-pill-for-weight-loss-that-can-be-taken-any-time-of-day-without-food-or-water-restrictions-302731485.htmlSOURCE Eli Lilly and Company

Original: FDA approves Lilly's Foundayo™ (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions