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Merck and Gilead Provide Update on Phase 3 KEYNOTE-D46/EVOKE-03 StudyJune 8, 2026 4:30 PM
Business Wire Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Gilead Sciences, Inc. (Nasdaq: GILD) today announced the discontinuation of the Phase 3 KEYNOTE-D46/EVOKE-03 study investigating Gilead’s Trodelvy® (sacituzumab govitecan-hziy) in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, compared to KEYTRUDA monotherapy in certain patients with previously untreated metastatic non-small cell lung cancer, whose tumors expressed PD-L1 (tumor proportion score [TPS] ≥50%). The decision is based on the recommendation from the external Data Monitoring Committee (eDMC) following their review of the data from the pre-specified final analysis of progression-free survival (PFS) and interim analysis of overall survival (OS). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260608789974/en/ A numerical improvement in PFS was observed, but did not reach statistical significance. The probability of achieving statistically significant OS is unlikely at the planned final analysis. The safety profile of Trodelvy in combination with KEYTRUDA was consistent with the known safety of each agent. No new safety signals were identified with the combination. These data will be presented at a future medical meeting. Regulatory authorities have been informed. Merck will inform study investigators of the recommendation from the DMC and advise patients in the study to speak to their physician regarding treatment. There are no changes to ongoing Trodelvy or Merck studies. The companies are grateful to the patients, families, and healthcare professionals who participated in the KEYNOTE-D46/EVOKE-03 study and contributed to this important work. Trodelvy is a registered trademark of Gilead Sciences, Inc., or its related companies. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About Metastatic Non-Small Cell Lung Cancer Lung cancer is one of the most common cancers worldwide, with an estimated 2.5 million new cases reported globally in 2022. Non-small cell lung cancer (NSCLC) accounts for approximately 80% to 85% of lung cancers, and nearly half of these NSCLC patients are diagnosed only after the disease has spread, when treatment options are more limited and long-term survival remains low. Despite treatment advances, the 5-year survival rate for metastatic NSCLC is less than 10%. While immunotherapy, with or without chemotherapy, is a standard first treatment option, it does not work for everyone, and new treatment options are needed. About KEYNOTE-D46/EVOKE-03 The KEYNOTE-D46/EVOKE-03 study is a global, open-label, randomized Phase 3 trial, sponsored by Merck, evaluating the efficacy and safety of Trodelvy (sacituzumab govitecan-hziy) in combination with KEYTRUDA (pembrolizumab) compared with KEYTRUDA monotherapy in patients with previously untreated metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 with a tumor proportion score (TPS) ≥50% and do not have sensitizing EGFR, ALK or ROS1 genomic alterations. Approximately 620 patients were enrolled across study sites worldwide. Patients were randomized 1:1 to receive either Trodelvy (10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle) plus KEYTRUDA (200 mg intravenously on Day 1 of a 21-day cycle), or KEYTRUDA monotherapy (200 mg intravenously on Day 1 of a 21-day cycle). KEYTRUDA was administered for up to 35 cycles, and Trodelvy was continued until disease progression, death, unacceptable toxicity or another treatment discontinuation criterion was met. The dual primary endpoints of the study are progression-free survival (PFS) as assessed by blinded independent central review (BICR) according to RECIST v1.1, and overall survival (OS). Secondary endpoints include objective response rate (ORR), duration of response (DOR), patient-reported outcomes (PROs) and safety. More information about the study is available at ClinicalTrials.gov: NCT05609968. About Trodelvy Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect. Trodelvy is currently approved in more than 60 countries for second-line or later metastatic triple-negative breast cancer (TNBC) and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC). Healthcare professionals have well-established experience with Trodelvy, which has shown generally consistent outcomes across both clinical trials and real-world use in more than 75,000 breast cancer patients across 60+ countries. Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in small cell lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity. Indications for Trodelvy TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with: Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. U.S. Important safety information FOR TRODELVY BOXED WARNING: NEUTROPENIA AND DIARRHEA TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay. TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses. CONTRAINDICATIONS Severe hypersensitivity reaction to TRODELVY. WARNINGS AND PRECAUTIONS Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI. Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments. Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions. Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting. Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function. Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose. ADVERSE REACTIONS In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%). In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes. In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes. DRUG INTERACTIONS UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY. UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY. Please see full Prescribing Information, including BOXED WARNING. About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Selected KEYTRUDA® (pembrolizumab) Indications in the U.S. Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information. Selected Important Safety Information for KEYTRUDA Severe and Fatal Immune-Mediated Adverse Reactions KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution. Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Immune-Mediated Colitis KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (

Gilead and Merck Announce Positive Topline Results From Two Phase 3 Studies Evaluating Islatravir/Lenacapavir, an Oral Once-Weekly HIV TreatmentJune 8, 2026 4:35 PM
Business Wire – Novel Investigational Combination Pairs Merck’s Islatravir, a Next-Generation Nucleoside Analog with Distinct Mechanisms of Action, Including Reverse Transcriptase Translocation Inhibition, with Gilead’s Lenacapavir, a First-in-Class Capsid Inhibitor that Disrupts HIV at Multiple Stages of its Lifecycle – – Islatravir/Lenacapavir has the Potential to be the First Approved Long-Acting Oral HIV Treatment Taken Once-Weekly – Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the primary efficacy endpoint at Week 48 was met in both the Phase 3 ISLEND-1 and ISLEND-2 trials with the investigational oral once-weekly single-tablet HIV treatment regimen of islatravir/lenacapavir. The ISLEND trials are evaluating the efficacy and safety of islatravir 2 mg/lenacapavir 300 mg (ISL/LEN) in people with HIV who are virologically suppressed and switched from BIKTARVY® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) (ISLEND-1) or standard of care antiretroviral regimens (ISLEND-2). The safety profile of ISL/LEN was generally comparable to the comparator regimens studied in the ISLEND trials, and no new safety concerns were identified. Gilead and Merck plan to file the Phase 3 data from the ISLEND trials with regulatory authorities globally and submit the detailed findings for presentation at a future scientific congress. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260608276598/en/ “Long-acting oral therapies represent a new wave of transformational innovation in HIV drug development, with the potential to reshape the landscape of care,” said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences. “Innovative oral HIV treatment options that allow for less frequent dosing may make a meaningful difference in the lives of people living with the virus, potentially offering more flexibility and discretion.” The primary efficacy endpoint of ISLEND-1 and ISLEND-2 was the percentage of participants with HIV-1 RNA levels ≥ 50 copies/mL at Week 48, defined by the FDA snapshot algorithm. In the double-blind ISLEND-1 trial, the once-weekly, single-tablet regimen of ISL/LEN was found to be statistically non-inferior to BIKTARVY. In the open-label ISLEND-2 trial, ISL/LEN was found to be statistically non-inferior to standard of care daily oral antiretroviral therapy regimens. The safety profile of ISL/LEN was generally comparable to BIKTARVY in ISLEND-1 and to standard of care antiretroviral regimens in ISLEND-2. “These results underscore the shared focus and commitment that we and our collaborators at Gilead have on continuing research to help people living with HIV. By advancing this investigational novel once-weekly oral regimen of islatravir and lenacapavir, we aim to bring forward a new long-acting oral option that, if approved, would represent the first of its kind with less frequent dosing and further expand options for people living with HIV,” said Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. The combination of islatravir and lenacapavir targets multiple stages of HIV-1 replication, potentially offering people with HIV who are virologically suppressed a novel, long-acting oral single-tablet regimen. The potency and pharmacokinetic profiles of islatravir and lenacapavir enable long-acting dosing as a once-weekly tablet for HIV treatment, if approved. Islatravir and lenacapavir in combination are investigational and not approved for use. There is currently no cure for HIV or AIDS. About ISLEND-1 ISLEND-1 (NCT06630286) is a Gilead-sponsored, multicenter Phase 3 randomized, double-blind, active-controlled trialdesigned to evaluate the safety and efficacy of switching to a once-weekly tablet of islatravir/lenacapavir (ISL/LEN) versus continuing treatment with BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) in people with virologically suppressed HIV (HIV-1 RNA levels < 50 copies/mL) on BIKTARVY for ≥ 6 months prior to screening. Participants were randomized 1:1 to receive initial doses of ISL/LEN on Day 1 and Day 2 followed by once-weekly ISL/LEN from Day 8 to Week 96 plus placebo-to-match BIKTARVY daily, or BIKTARVY daily plus placebo-to-match initial doses of ISL/LEN on Day 1 and Day 2 and placebo-to-match once-weekly ISL/LEN from Day 8 to Week 96. The primary endpoint was the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48, as determined by the US FDA-defined snapshot algorithm. Key secondary endpoints included the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96, as determined by the US FDA-defined snapshot algorithm; the proportion of participants with virologic suppression (HIV viral load < 50 copies/mL per US FDA Snapshot) at Week 48 and Week 96; change from baseline in CD4 cell count at Week 48 and Week 96; and the proportion of participants treated with ISL/LEN who discontinued treatment due to treatment-emergent adverse events. About ISLEND-2 ISLEND-2 (NCT06630299) is a Gilead-sponsored, multicenter Phase 3 randomized, open-label, active-controlled trialevaluating the safety and efficacy of switching to a once-weekly tablet of ISL/LEN versus continuation of standard of care treatment in people with virologically suppressed HIV (HIV-1 RNA levels < 50 copies/mL) on a stable standard of care antiretroviral regimen for ≥ 6 months prior to screening. A standard of care regimen included two or three antiretroviral medicines, including integrase strand transfer inhibitors (INSTI), nucleoside reverse transcriptase inhibitors (NRTIs), boosted protease inhibitors (PI) and non-nucleoside reverse transcriptase inhibitors (NNRTI). Participants either received an initial dose of ISL/LEN followed by once-weekly ISL/LEN from Day 8 to Week 96, or continued their standard of care treatment with two/three antiretroviral medicines up to Week 96. The primary endpoint is the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 by FDA-defined Snapshot Algorithm. Key secondary endpoints included the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96, as determined by the US FDA-defined snapshot algorithm; the proportion of participants with virologic suppression (HIV viral load < 50 copies/mL per US FDA Snapshot) at Week 48 and Week 96; change from baseline in CD4 cell count at Week 48 and Week 96; and the proportion of participants treated with ISL/LEN who discontinued treatment due to treatment-emergent adverse events. About Lenacapavir The multi-stage mechanism of action of lenacapavir is distinguishable from other approved classes of antiretroviral agents. While most antiretrovirals act on one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known exhibited cross-resistance in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV treatment and prevention research program. Lenacapavir is being developed as a foundation for potential future HIV therapies to offer both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono-agent, that help address the individual needs and preferences of people and communities affected by HIV. For an overview of Gilead’s HIV treatment and prevention clinical development program, please click here. About Islatravir (MK-8591) Islatravir (MK-8591) is Merck’s potent, next-generation nucleoside analog that blocks HIV-1 replication by multiple mechanisms including inhibition of reverse transcriptase translocation, resulting in immediate chain termination, and induction of structural changes in the viral DNA (delayed chain termination). Islatravir is anchoring multiple ongoing early and late-stage clinical trials of two-drug regimens in combination with other Merck antiretrovirals for potential treatments for HIV-1. Islatravir is being studied in Phase 3 in combination with Merck’s doravirine (DOR/ISL) as a once-daily pill for treatment of HIV-1 infection in adults with no prior antiviral treatment history and in Phase 2b in combination with Merck’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) ulonivirine (MK-8507) as an oral once-weekly treatment for HIV-1. For an overview of Merck’s HIV treatment and prevention clinical development program, please click here. About Gilead HIV For almost 40 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV prevention medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic worldwide. Gilead has been repeatedly recognized as one of the top two leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. Discover more about Gilead’s unique collaborations worldwide and the work to help end the HIV epidemic. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. Merck’s Commitment to HIV For 40 years, Merck has been committed to scientific research and discovery in HIV leading to scientific breakthroughs that have helped change HIV treatment. Our work has helped pioneer the development of new options across multiple drug classes to help those impacted by HIV. Today, we are developing a series of antiviral options designed to help people manage HIV and protect people from HIV. We are researching for real life and want to ensure people are not defined by HIV. Our work focuses on transformational innovations, collaborations with others in the global HIV community, and access initiatives aimed at helping to end the HIV epidemic for everyone. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Gilead Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving lenacapavir (such as ISLEND-1 and ISLEND-2); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation, such as oral once-weekly single-tablet HIV treatment regimen of islatravir/lenacapavir, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). BIKTARVY, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X (@Gilead Sciences) and LinkedIn, or contact Gilead Public Affairs. View source version on businesswire.com: https://www.businesswire.com/news/home/20260608276598/en/ GILEAD CONTACTS:
Priscilla White, Media
public_affairs@gilead.com Jacquie Ross, Investors
investor_relations@gilead.com MERCK CONTACTS:
Melissa Moody, Media
mediarelations@merck.com Damini Chokshi, Investors
investor_relations@merck.com Original: Gilead and Merck Announce Positive Topline Results From Two Phase 3 Studies Evaluating Islatravir/Lenacapavir, an Oral Once-Weekly HIV Treatment

Gilead Applauds Collaborative Efforts to Launch Lenacapavir for HIV Prevention in South AfricaJune 5, 2026 3:00 AM
Business Wire Gilead applauds the leadership of the Government of South Africa and the Global Fund for accelerating access to lenacapavir, a long-acting HIV prevention medication. This marks an important step toward expanding access to lenacapavir for communities most affected by HIV. “South Africa is at the heart of global efforts to end HIV. With the country’s launch of lenacapavir, there is now an opportunity to rapidly accelerate progress,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. “Through partnerships with country leadership, the Global Fund, and the U.S. State Department via PEPFAR, Gilead is working to bring lenacapavir to the communities most in need, ahead of the broad rollout of generic versions of the medicine.” South Africa carries the largest HIV burden globally, with approximately 7.8 million people living with HIV and an estimated 170,000 new infections each year, including a disproportionate impact on women, according to national epidemiological data. Despite significant progress, the scope of the country’s epidemic and the incidence of new infections underscore the need for more effective HIV prevention options. The Phase 3 PURPOSE 1 and PURPOSE 2 trials included many sites in South Africa, reflecting Gilead’s commitment to developing solutions in the communities most affected by HIV. Gilead’s efforts to accelerate access are reflected through our global access commitments, including working with partners such as the Global Fund and the U.S. State Department, through PEPFAR to support initial supply (at no profit to the company), advancing voluntary licensing agreements to enable broad geographic reach, and supporting local and regional manufacturing pathways to strengthen long-term supply resilience. Gilead is committed to supporting broad, equitable and sustainable access to lenacapavir for HIV prevention globally. Through our royalty-free voluntary license agreements with six manufacturers, we are enabling generic supply across 120 low- and lower-middle-income countries as part of a comprehensive access strategy to support long-term, lower-cost medication supply. As highlighted by today’s announcement and the strong, coordinated leadership demonstrated in South Africa, the continued collaboration between countries, global health partners and industry will be critical to reaching people with new innovations at scale, reducing new HIV infections and advancing our shared goal of ending HIV as a public health threat. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). View source version on businesswire.com: https://www.businesswire.com/news/home/20260605187130/en/ Ashleigh Koss, Media
Public_Affairs@gilead.com Original: Gilead Applauds Collaborative Efforts to Launch Lenacapavir for HIV Prevention in South Africa

Gilead Sciences and Lakefront Complete Acquisition of Ouro Medicines to Further Expand Inflammation PipelineJune 4, 2026 4:15 PM
Business Wire – Companies will collaborate on the development of gamgertamig, a potential first-in-class and best-in-class T cell engager in autoimmune diseases – Gilead Sciences, Inc. (Nasdaq: GILD) and Lakefront Biotherapeutics NV (Euronext & Nasdaq: LKFT) today announced the successful completion of the previously announced acquisition of Ouro Medicines to advance T cell engager therapies for autoimmune diseases. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260604796427/en/ The acquisition adds gamgertamig (OM336), a clinical-stage BCMAxCD3 T cell engager, to Gilead’s growing inflammation portfolio and will be the foundation of Lakefront’s clinical development pipeline. Gamgertamig is designed to enable rapid and deep plasma cell and B cell depletion following a limited subcutaneously administered treatment course with the potential to induce durable disease control in severe antibody-mediated orphan diseases including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP). Gamgertamig has been granted both Fast Track and Orphan Drug Designation by the U.S. FDA for the treatment of AIHA and ITP and is expected to enter registrational studies as early as 2027. The addition of gamgertamig builds on Gilead’s long-term strategy to invest in differentiated science and accelerate the development of therapies that address significant unmet need. Combined with existing expertise in immunology and cell therapy, this approach supports the company’s ambition to shift treatment paradigms from chronic disease management toward the potential for durable immune reset. Under the terms of the agreement, Gilead acquired all the outstanding equity of Ouro Medicines for $1,675 million and up to $500 million in contingent milestone payments. Lakefront and Gilead will equally split the upfront payment, subject to customary adjustments, and contingent milestone payments of up to $500 million. With this transaction, Lakefront has acquired substantially all of Ouro Medicines’ team and operational assets in connection with Gilead’s acquisition of Ouro Medicines and will collaborate with Gilead on the development of gamgertamig. As part of the collaboration, Lakefront is responsible for the ongoing and future Phase 1/2 clinical studies of gamgertamig, with Gilead leading the registrational and later-stage studies. Gilead will retain sole worldwide commercialization rights, including all related costs, globally outside of Keymed’s territories. Lakefront will receive tiered royalties of 20%–23% on net sales of gamgertamig from Gilead. Lakefront has also in-licensed a preclinical portfolio of three additional autoimmune focused programs originally from Ouro with an opt-in for Gilead for a 50/50 profit split post clinical proof-of-concept for $75 million per program. The transaction provides relief under the Option, License and Collaboration Agreement dated July 14, 2019, between Lakefront and Gilead (the “OLCA”) to enable Lakefront to deploy at least $500 million of its available cash independently from Gilead and outside the scope of the OLCA and the Ouro transaction, including up to $150 million for share buybacks. The Ouro portfolio will be the cornerstone of Lakefront’s R&D pipeline. Following this transaction, Lakefront will continue to have a majority of its cash remaining for additional strategic transactions and other capital allocation priorities. Lakefront’s year-end 2026 cash balance is expected to be approximately €2B. About Gamgertamig Gamgertamig is an investigational BCMAxCD3 bispecific T cell engager for the treatment of autoantibodies driven immune-mediated disease. Gamgertamig has been granted Orphan Drug Designation and Fast Track Designation by the U.S. FDA for certain autoimmune diseases. Gamgertamig is currently in Phase 2 studies is expected to enter registrational studies as early as 2027. Gamgertamig is in-licensed from Keymed Biosciences, which owns the rights to develop the program in Greater China. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. About Lakefront® Biotherapeutics Lakefront Biotherapeutics (formerly known as Galapagos) is a biotechnology company built to bring meaningful medicines to patients with serious diseases in therapeutic areas of unmet need. The Company combines world-class deal making expertise with capital to identify, acquire, and advance promising opportunities that have the potential to drive value for patients and shareholders. Applying a modality-agnostic asset selection approach and operational flexibility, Lakefront Biotherapeutics prioritizes oncology and immunology & inflammation programs with clear clinical proof-of-concept in emerging areas. For more information, visit https://www.lakefrontbio.com or follow us on LinkedIn or X. Gilead Forward-Looking Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of Gilead and Ouro Medicines and members of their respective senior management teams. In some cases, forward-looking statements can be identified by the use of words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “seek,” “may,” “plan,” “project,” “should,” “target,” “will,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, without limitation, statements regarding the transactions and related matters, prospective performance and opportunities, post-closing operations and the outlook for the companies’ businesses; the potential of Ouro Medicines’ programs; timing of prospective clinical trials; Gilead’s long-term strategy; and any assumptions underlying any of the foregoing. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: the effects of the transactions on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; the risk that the businesses will not be integrated successfully and that other anticipated benefits from the transactions will not be realized; the impact of competitive products and pricing; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; transaction costs; actual or contingent liabilities; the risk that Gilead may not realize the expected benefits of the Ouro Medicines acquisition or the Lakefront license and collaboration; the ability of Gilead to advance their product pipeline and successfully commercialize product candidates following the acquisition; the ability of the parties to initiate and complete clinical trials involving such product candidates in the currently anticipated timelines or at all; the possibility of unfavorable results from one or more of such trials involving such product candidates; uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the U.S. Securities and Exchange Commission. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Lakefront Biotherapeutics Forward-Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “believe,” “anticipate,” “expect,” “intend,” “plan,” “seek,” “upcoming,” “future,” “estimate,” “may,” “will,” “could,” “would,” “potential,” “forward,” “goal,” “next,” “continue,” “should,” “encouraging,” “aim,” “progress,” “remain," “explore,” “further” as well as similar expressions. These statements include, but are not limited to, statements regarding Lakefront’s business development strategy and clinical development pipeline, expected benefits and potential of gamgertamig, post-closing operations and benefits of the transaction, timing of prospective clinical trials, and our expected cash balance in 2026 and expected uses of cash. Lakefront cautions the reader that forward-looking statements are based on our management’s current expectations and beliefs and are not guarantees of future performance. Forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause actual events, financial condition and liquidity, performance or achievements, or the industry in which we operate, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. In addition, even if our results, performance, financial condition and liquidity, and the development of the industry in which Lakefront operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Such risks include, but are not limited to, the risk that Lakefront’s financial estimates, including cash position, may be incorrect (including because one or more of its assumptions may not be realized); risks associated with the changes to our capital allocation strategies; the risk that we will not be able to execute on our currently contemplated business plan or strategy and/or will revise our business plan or strategy; risks related to our ability to successfully identify, pursue and consummate new transformational business development transactions, including our ability to identify product candidates that will have commercial success and/or be profitable; the risk that the commercial potential of gamgertamig proves to be inaccurate; the risk that the businesses will not be integrated successfully and that other anticipated benefits from the transactions will not be realized; the inherent risks and uncertainties associated with competitive developments, clinical trials, recruitment of patients, product development activities and regulatory approval requirements; risks related to our reliance on collaborations with third parties (including, but not limited to, our collaboration partner Gilead); the impact of competitive products and pricing; and the risk that our estimates regarding the commercial potential of our product candidates (if approved) or expectations regarding the costs and revenues associated with the commercialization rights may be inaccurate. A further list and description of these risks, uncertainties and other risks can be found in our filings and reports with the Securities and Exchange Commission (SEC), including in our most recent annual report on Form 20-F filed with the SEC and our subsequent filings and reports filed with the SEC. Given these risks and uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. In addition, even if the result of our operations, financial condition and liquidity, or the industry in which we operate, are consistent with such forward-looking statements, they may not be predictive of results, performance or achievements in future periods. These forward-looking statements speak only as of the date of publication of this release. We expressly disclaim any obligation to update any such forward-looking statements in this release to reflect any change in our expectations or any change in events, conditions or circumstances, unless specifically required by law or regulation. Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). View source version on businesswire.com: https://www.businesswire.com/news/home/20260604796427/en/ Gilead
Ashleigh Koss, Media
public_affairs@gilead.com Jacquie Ross, Investors
investor_relations@gilead.com Lakefront Biotherapeutics
Sherri Spear
+1 412 522 6418
sherri.spear@lakefrontbio.com Original: Gilead Sciences and Lakefront Complete Acquisition of Ouro Medicines to Further Expand Inflammation Pipeline

Phase 3 ASSURE Interim Data: Majority of People in the Study with ALP 1–1.67×ULN Achieved High and Sustained Composite ALP Normalization at 24 Months with Gilead’s Livdelzi (Seladelpar)May 27, 2026 2:00 AM
Business Wire – ALP Is a Key Marker of Disease Activity in People Living With PBC, With Elevations Above Normal Associated with Increased Risk of Disease Progression – – Further Analyses of the Phase 3 ASSURE Study Demonstrate Sustained ALP Normalization and Show Exploratory Outcomes of Stable or Improved Liver Stiffness, Providing Supportive, Long-term Evidence – Gilead Sciences, Inc. (Nasdaq: GILD) today shared new results from a post hoc analysis showing that Livdelzi® (seladelpar) was associated with high and sustained rates of normalization of a key liver marker (ALP) in people living with primary biliary cholangitis (PBC). In an ongoing Phase 3 study, participants with elevated ALP levels (between 1.0 and 1.67×ULN) experienced reductions in ALP after treatment. These data highlight the potential role of Livdelzi in people with PBC who continue to have elevated ALP despite prior treatment with first-line therapy. These findings are highly relevant for people living with PBC with inadequately controlled disease based on elevated ALP levels—a population historically underrepresented in randomized clinical trials. The data will be presented at the European Association for the Study of the Liver (EASL) Congress 2026, held May 27–30 in Barcelona, Spain. “Achieving ALP normalization is increasingly recognized as a key treatment goal in PBC due to its association with improved long-term clinical outcomes,” said Cynthia Levy, MD, Professor of Medicine in the Division of Digestive Health and Liver Diseases, and Associate Director of the Schiff Center for Liver Diseases at the University of Miami. “These data show that seladelpar can help people who have not reached ALP normalization achieve this important biochemical target and support its potential role across a broader range of people living with PBC, including those with lower ALP levels.” ASSURE is an ongoing, open-label Phase 3 study evaluating the long-term safety and efficacy of Livdelzi in people living with PBC who previously participated in Livdelzi clinical trials. In an interim post hoc analysis, a high and sustained reduction in ALP was observed with Livdelzi treatment in participants with elevated baseline ALP levels between 1.0 and 1.67×ULN. Among 50 participants, 83% of evaluable participants achieved composite ALP normalization—defined as ALP ≤1×ULN with ≥15% reduction—at 12 months, and 74% achieved the same endpoint at 24 months, demonstrating a persistent response over two years of treatment. Mean ALP levels declined substantially from baseline and remained reduced through long-term follow-up. Improvements were also observed in other markers of cholestasis, including gamma-glutamyl transferase (GGT), and total bilirubin remained stable overall. This population included individuals with recognized risk factors for disease progression, including cirrhosis and younger age at diagnosis. Livdelzi was found to be generally well tolerated, with no treatment discontinuations due to adverse events with up to two years of follow-up and no new safety signals observed, consistent with previously reported findings. Separately, in an exploratory analysis across the full ASSURE population, 85% (n=77/91) of participants who achieved biochemical response at 12 months and were followed up through 3 years maintained or improved liver stiffness measurements. Liver stiffness stability is a commonly used non-invasive marker associated with long-term outcomes and is descriptive in nature in this open-label analysis. “The data presented add to the growing body of clinical evidence supporting the role of Livdelzi as a therapeutic approach for people living with PBC,” said Swati Tole, MD, MS, Clinical Development, Inflammation at Gilead Sciences. “Combining ALP normalization with effective symptom management provides a more holistic approach to care. With Livdelzi, we aim to address both—helping improve pruritus, one of the most debilitating symptoms of PBC, and normalize ALP, a key marker of disease progression risk—supporting a comprehensive approach to disease management.” Additional interim analyses from the ASSURE and pivotal RESPONSE studies help support the long-term efficacy and safety profile of Livdelzi across a broad range of people living with PBC. These findings build on the results shared at The Liver Meeting 2025 and further support its potential to contribute to sustained clinical benefit in both broad and high-risk PBC populations. Livdelzi (seladelpar) is approved for use for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA in the United States (U.S.), United Kingdom (UK), Australia and Israel, as well as the European Economic Area (EEA), Switzerland and Canada where it is marketed as Lyvdelzi. For more information on the EASL Congress 2026 and Gilead’s data presented, please visit the congress website. About ASSURE (NCT03301506) ASSURE is an open-label, long-term study to evaluate the safety and tolerability of Livdelzi in people with primary biliary cholangitis (PBC) who have already participated in other PBC clinical trials of Livdelzi. The ASSURE study includes participants from previous studies of Livdelzi in PBC, including the Phase 3 registrational RESPONSE study and legacy clinical trials. Legacy studies include the open label Phase 2 dose-ranging study (2 mg, 5 mg, or 10 mg Livdelzi), the open label Phase 3/4 long-term safety study (5 mg or 10 mg Livdelzi), the Phase 3 placebo-controlled ENHANCE study (5 mg or 10 mg Livdelzi vs placebo), and the PBC and hepatic impairment study for Livdelzi. About RESPONSE (NCT04620733) RESPONSE was a pivotal Phase 3, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of Livdelzi in adults with primary biliary cholangitis (PBC) who have shown inadequate response or intolerance to ursodeoxycholic acid (UDCA) defined by an ALP >= 1.67x ULN. The trial enrolled 193 participants across multiple sites worldwide. RESPONSE assessed the key biomarker of cholestasis alkaline phosphatase (ALP) and other parameters of liver function, as well as secondary endpoints including pruritus and other patient quality of life measurements. Participants in the RESPONSE trial received a daily oral dose of 10 mg of Livdelzi for 12 months. The trial aimed to address the high unmet need for effective second-line therapies for individuals with PBC. The approvals of Livdelzi were based primarily on data from the RESPONSE study. About PBC PBC is a chronic, autoimmune disease of the bile ducts that affects approximately 130,000 Americans. PBC is more common in women and causes liver damage that can progress to liver failure and result in the need for liver transplant, if left untreated. The most common symptoms of PBC are pruritus (chronic itch) and fatigue, which many people living with PBC can experience and may profoundly compromise quality of life. Symptoms of PBC are often invisible to others, and the journey to a PBC diagnosis can be long and challenging. There is currently no cure for PBC, and treatment goals include reducing the risk of disease progression and reducing symptoms related to cholestasis (impaired bile flow), such as cholestatic itch. Treatment effect is primarily assessed through liver biochemical tests, including improvements in alkaline phosphatase (ALP), an important marker of disease activity associated with long-term outcomes in PBC. About Livdelzi Livdelzi (seladelpar) is an oral PPAR-delta agonist, or delpar, for the treatment of primary biliary cholangitis (PBC). PPAR-delta is known to regulate key metabolic and liver disease pathways. Preclinical and clinical data indicate that Livdelzi has anticholestatic, anti-inflammatory, antipruritic, and antifibrotic effects. Clinical trial data demonstrate that Livdelzi improves key markers associated with disease activity, including biochemical response and alkaline phosphatase (ALP) normalization, with sustained effects observed over long-term follow-up. These findings are supported by clinical studies evaluating Livdelzi in hundreds of participants treated for up to five years. Livdelzi addresses ongoing unmet needs for people living with PBC, including those who remain inadequately controlled on existing therapies. Pruritus is a common symptom of PBC that can significantly impair quality of life, and prior studies have shown statistically significant and clinically meaningful improvements in pruritus with Livdelzi compared with placebo. U.S. Indication for Livdelzi Livdelzi is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The FDA approved this indication under accelerated approval based on a reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Limitations of Use: Use of Livdelzi is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). U.S. Important Safety Information for LIVDELZI Warnings and Precautions Fractures: Fractures occurred in 4% of LIVDELZI-treated patients compared to no placebo-treated patients. Consider the risk of fracture in the care of patients treated with LIVDELZI and monitor bone health according to current standards of care. Liver Test Abnormalities: LIVDELZI has been associated with dose-related increases in serum transaminase (AST and ALT) levels > 3 x ULN in patients receiving 50 mg and 200 mg once daily (5x and 20x higher than the recommended dosage of 10 mg once daily). Transaminase levels returned to pretreatment levels upon LIVDELZI discontinuation. In the pivotal RESPONSE study, LIVDELZI 10 mg once daily did not show a similar pattern for increases in transaminase levels Perform baseline clinical and laboratory testing when starting LIVDELZI and monitor thereafter according to routine patient management. Interrupt treatment if the liver tests (ALT, AST, total bilirubin, and/or ALP) worsen, or if the patient develops signs and symptoms of clinical hepatitis (eg, jaundice, right upper quadrant pain, eosinophilia). Consider permanent discontinuation if liver tests worsen after restarting LIVDELZI. Biliary Obstruction: Avoid use of LIVDELZI in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt LIVDELZI and treat as clinically indicated. Adverse Reactions The most common adverse reactions (≥5%) with LIVDELZI were headache (8%), abdominal pain (7%), nausea (6%), abdominal distension (6%), and dizziness (5%). Drug Interactions OAT3 Inhibitors and Strong CYP2C9 Inhibitors: Avoid coadministration with LIVDELZI due to increased LIVDELZI exposure. Rifampin: Monitor biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during LIVDELZI treatment. Coadministration may result in delayed or suboptimal biochemical response of LIVDELZI. Dual Moderate CYP2C9 and Moderate-to-Strong CYP3A4 Inhibitors and BCRP Inhibitors (eg, cyclosporine): Monitor closely for adverse effects. Concomitant administration with LIVDELZI may increase LIVDELZI exposure. CYP2C9 Poor Metabolizers Using Moderate-to-Strong CYP3A4 Inhibitors: Monitor more frequently for adverse reactions as concomitant use of a moderate-to-strong CYP3A4 inhibitor in patients who are CYP2C9 poor metabolizers may increase LIVDELZI exposure and risk of LIVDELZI adverse reactions. Bile Acid Sequestrants: Administer LIVDELZI at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as great an interval as possible. Pregnancy and Lactation Pregnancy: There are insufficient data from human pregnancies exposed to LIVDELZI to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Report pregnancies to Gilead Sciences, Inc., at 1-800-445-3235. Lactation: There are no data on the presence of LIVDELZI in human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for LIVDELZI and any potential adverse effects on the breastfed infant from LIVDELZI. About Gilead Sciences in Liver Disease For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. The company has helped to transform hepatitis C from a chronic condition into one that can be cured for millions of people. For individuals living with hepatitis B or D, Gilead's focus on advancing medicines drives hope that today’s research will turn into tomorrow’s cures. Beyond viral hepatitis, Gilead is working to deliver advanced treatments for people living with PBC. The commitment of Gilead doesn’t stop there. Through ground-breaking science and collaborative partnerships, the company strives to create healthier futures for everyone living with liver disease. Gilead remains devoted to a future without liver disease. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving seladelpar (such as the ASSURE, RESPONSE and any confirmatory studies); uncertainties relating to regulatory applications and related filing and approval timelines, including additional pending and potential applications for seladelpar; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; uncertainties regarding Gilead’s ability to coordinate access to seladelpar in a timely manner or at all; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Livdelzi, Lyvdelzi, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. U.S. full Prescribing Information for Livdelzi is available at www.gilead.com. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). View source version on businesswire.com: https://www.businesswire.com/news/home/20260526228499/en/ Priscilla White, Media
public_affairs@gilead.com Jacquie Ross, Investors
investor_relations@gilead.com Original: Phase 3 ASSURE Interim Data: Majority of People in the Study with ALP 1–1.67×ULN Achieved High and Sustained Composite ALP Normalization at 24 Months with Gilead’s Livdelzi (Seladelpar)

FDA Grants Accelerated Approval to Gilead’s Hepcludex® (bulevirtide-gmod), the First and Only Approved Treatment for Chronic Hepatitis Delta Virus (HDV)May 22, 2026 2:00 PM
Business Wire – Chronic HDV is considered the most severe form of viral hepatitis due to rapid disease progression towards liver failure and liver-related death – – Approval introduces the first FDA-approved therapy for this disease with limited treatment options and high unmet need – Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Hepcludex® (bulevirtide-gmod) 8.5 mg for the treatment of adults living with chronic hepatitis delta virus (HDV) infection, making it the first and only approved treatment for HDV in the United States. The FDA granted accelerated approval to Hepcludex based on reductions in HDV RNA and normalization of alanine aminotransferase (ALT), supported primarily by data from the pivotal, controlled Phase 3 MYR301 study. At Week 48, the study demonstrated a statistically significant improvement versus the control (delayed treatment) group in a combined virologic and biochemical response. Improvement in disease-related clinical outcomes has not been established. Continued approval for the approved indication may be contingent on verification and description of clinical benefit in a confirmatory trial. Chronic HDV is considered the most severe form of viral hepatitis and is associated with a markedly higher risk of rapid disease progression, liver failure, and mortality compared with HBV alone. In the United States, studies in general populations have estimated that HDV affects between 2% and 4% of individuals who have chronic hepatitis B virus (HBV), representing ~40,000-80,000 people. “Hepatitis delta virus is associated with rapid progression of liver disease and a high risk of serious or even life-threatening liver-related complications,” said Dr. Ira Jacobson, MD, Department of Medicine at NYU Grossman School of Medicine. “For patients, an HDV diagnosis means managing two distinct viral liver diseases—hepatitis B and hepatitis D—each contributing to disease progression, monitoring demands, and treatment complexities. The approval of Hepcludex for chronic HDV represents a critical advancement, introducing a long-awaited option that begins to address a significant unmet medical need and has the potential to meaningfully alter the course of this devastating disease for people living with HDV in the United States.” MYR301 (NCT03852719) evaluated the efficacy and safety of Hepcludex in adults with chronic HDV, with treatment administered for up to 144 weeks followed by 96 weeks of off-treatment follow-up. Hepcludex met its primary endpoint at Week 48, with continued treatment, demonstrated sustained efficacy and was generally well tolerated through up to 144 weeks of on-treatment exposure. “The approval of Hepcludex represents a historic milestone for people living with HDV in the United States, marking the first FDA-approved treatment for HDV,” said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences. “This reflects years of close engagement with the FDA and the application of rigorous science to address a serious disease with long-standing unmet need. With Hepcludex, we now have the opportunity to deliver a meaningful clinical advancement that has the potential to change the trajectory of HDV for patients in the U.S.” U.S. Access and Hepcludex Approval Across Markets The Gilead Support Path® Program offers information and resources to help patients diagnosed with chronic HBV, HDV and hepatitis C virus (HCV) and primary biliary cholangitis (PBC), as well as healthcare professionals, understand coverage and financial options for prescribed Gilead treatments. Bulevirtide 2 mg is also approved for use in the European Economic Area (EEA) and other countries globally to treat people living with chronic HDV. Please see below for U.S. Indication and Important Safety Information for Hepcludex. U.S. Indication for Hepcludex Hepcludex (bulevirtide-gmod) 8.5 mg for injection is indicated for the treatment of chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization. An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). U.S. Important Safety Information for Hepcludex IMPORTANT SAFETY INFORMATION BOXED WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS D and B Severe acute exacerbations of hepatitis D and hepatitis B may occur after HEPCLUDEX is discontinued, especially in patients with cirrhosis, who may be at increased risk of more severe flares or progression to hepatic decompensation. Monitor hepatic function closely with both clinical and laboratory follow-up, including hepatitis B virus (HBV) DNA and hepatitis delta virus (HDV) RNA viral load, for at least six months in patients who discontinue HEPCLUDEX. Resumption of antiviral therapy may be warranted. Warnings and Precautions Hypersensitivity reactions including anaphylaxis: Hypersensitivity reactions, including anaphylaxis, have been reported with HEPCLUDEX. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue HEPCLUDEX and initiate appropriate treatment. Adverse Reactions Most common adverse reactions (incidence ≥10%; all grades) in HEPCLUDEX clinical trials were injection site reactions, headache, abdominal pain, fatigue and pruritus. Dosage and Administration Dosage in adults: 8.5 mg once daily administered by subcutaneous injection HEPCLUDEX should be continued as long as it is associated with a response to treatment. The optimal treatment duration is unknown. In all patients, manage the underlying HBV infection as clinically appropriate. Pregnancy and Lactation Pregnancy: There are insufficient data from human pregnancies exposed to HEPCLUDEX to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Lactation: There are no data on the presence of HEPCLUDEX in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for HEPCLUDEX and any potential adverse effects on the breastfed child from HEPCLUDEX or from the underlying maternal condition. About Hepcludex (bulevirtide) Hepcludex (bulevirtide) is a first-in-class entry inhibitor for the treatment of adults living with chronic hepatitis delta virus (HDV) infection. Chronic HDV infection is a serious liver disease that occurs only as a co-infection in individuals with chronic HBV and is associated with rapid disease progression, liver failure, and increased mortality. Hepcludex is supplied as a vial for once-daily subcutaneous injection. Each vial contains an 8.5 mg dose when prepared according to the Instructions for Use within FDA-approved labeling. Hepcludex works by blocking the entry of both HDV and HBV into liver cells, addressing a key step in the viral lifecycle. The FDA’s accelerated approval of Hepcludex is supported by data from the Phase 3 MYR301 study demonstrating that Hepcludex was an effective and generally well-tolerated treatment option, with durable efficacy observed through long-term treatment of up to 144 weeks. Hepcludex is supplied as a once-daily injectable therapy and represents the first and only treatment option for people living with HDV that received FDA accelerated approval in the United States, addressing a long-standing unmet medical need for this historically underserved patient community. As part of the FDA accelerated approval, Gilead has committed to a confirmatory long-term outcomes study, which has already been initiated in people living with chronic HDV. Continued approval may be contingent upon verification of clinical benefit. About HDV Chronic HDV is the most severe form of viral hepatitis and can have mortality rates as high as 50% within five years in cirrhotic patients. HDV occurs only as a co-infection in individuals who have HBV. It is estimated that at least 12 million people worldwide are currently co-infected with HDV and HBV. HDV co-infection is associated with a faster progression to liver fibrosis, cirrhosis and hepatic decompensation and an increased risk of liver cancer and death. In the U.S., it is estimated that there are ~40,000-80,000 people living with HDV. About Gilead Sciences in Liver Disease For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. We have helped to transform hepatitis C from a chronic condition into one that can be cured for millions of people. For people living with hepatitis B or D, our focus on advancing our medicines drives hope that today’s research will turn into tomorrow’s cures. Beyond viral hepatitis, we’re working to deliver advanced treatments for people living with PBC. But our commitment doesn’t stop there. Through our ground-breaking science and collaborative partnerships, we strive to create healthier futures for everyone living with liver disease. We are committed to a future without liver disease. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials or studies, including those involving bulevirtide; uncertainties relating to regulatory applications and related filing and approval timelines, including additional pending and potential applications for Hepcludex, and the risk that any such approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the risk that physicians may not see the benefits of prescribing Hepcludex for the treatment of HDV; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Hepcludex, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. U.S. full Prescribing Information for Hepcludex is available at www.gilead.com. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). View source version on businesswire.com: https://www.businesswire.com/news/home/20260522569258/en/ Priscilla White, Media
public_affairs@gilead.com Jacquie Ross, Investors
investor_relations@gilead.com Original: FDA Grants Accelerated Approval to Gilead’s Hepcludex® (bulevirtide-gmod), the First and Only Approved Treatment for Chronic Hepatitis Delta Virus (HDV)

Gilead Receives CHMP Positive Opinion for Trodelvy® in First-Line Metastatic Triple-Negative Breast Cancer for Patients Not Candidates for PD-(L)1 InhibitorsMay 22, 2026 7:47 AM
Business Wire – Recommendation Based on ASCENT-03 Study, Demonstrating Highly Statistically Significant and Clinically Meaningful Progression-Free Survival Versus Chemotherapy in PD-(L)1 Inhibitor Ineligible Patients– – Positive Opinion Marks a Significant Step Towards Introducing a Crucial First-line Treatment Option for People Living with Metastatic Triple-Negative Breast Cancer in the EU – Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) as a monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy. The European Commission decision on the additional Trodelvy indication is anticipated later in 2026. Metastatic TNBC is an aggressive form of breast cancer that is associated with low survival rates. For many patients with metastatic TNBC, first-line therapy may be their only line of treatment, necessitating an urgency to act using the most effective treatment options first to maximize patient outcomes. “Metastatic TNBC remains one of the most challenging breast cancer subtypes to treat, particularly at the time of first diagnosis of advanced disease, when therapeutic options are limited for many patients,” said Dr. Javier Cortes, Head of the International Breast Cancer Center, Madrid and Barcelona, Spain. “The CHMP’s positive opinion for sacituzumab govitecan represents an important step towards potential approval in this setting and reflects the clinically meaningful results observed in the ASCENT-03 study. Advancing effective treatment options earlier in the disease course is critical to improving outcomes for people living with metastatic TNBC.” The CHMP’s recommendation is based on data from the Phase 3 ASCENT-03 study which demonstrated a highly statistically significant and clinically meaningful progression-free survival of Trodelvy compared to standard of care chemotherapy as a first-line treatment. In ASCENT-03, Trodelvy demonstrated a 38% reduced risk of disease progression or death in patients who are not candidates for PD-1/PD-L1 inhibitors. Gilead has also submitted an application to the U.S. Food and Drug Administration for approval of Trodelvy in this indication based on the ASCENT-03 study. “This CHMP positive opinion for Trodelvy represents a pivotal moment for people with metastatic TNBC across Europe, and we look forward to hearing from the European Medicines Agency,” said Mika Kakefuda Derynck, MD, Senior Vice President, Clinical Development, Oncology at Gilead Sciences. “Building on the extensive clinical experience with Trodelvy in later lines of therapy, this recommendation has the potential to fundamentally change how we approach treating certain first-line metastatic TNBC patients, offering a much-needed option earlier in care when it can make the greatest difference. Each step forward means more options and more chances to change the story for people living this cancer.” Gilead has also submitted supplemental filings to the European Medicines Agency and the U.S. Food and Drug Administration for Trodelvy in combination with Keytruda® (pembrolizumab) for patients with PD-L1 positive unresectable locally advanced or metastatic TNBC, based on data from the Phase 3 ASCENT-04 study. These applications are currently under review. If approved, Trodelvy has the potential to be a backbone treatment in 1L mTNBC, across PD-L1 status. Trodelvy is currently approved as a second-line plus treatment for metastatic TNBC and for patients with pre-treated HR+/HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) metastatic breast cancer. Healthcare professionals have substantial clinical experience with Trodelvy, with more than 75,000 breast cancer patients treated across 60+ countries since 2020. It remains the only Trop-2-directed ADC to demonstrate meaningful overall survival benefits in both second-line or later metastatic TNBC and pre-treated HR+/HER2- metastatic breast cancer. It is also the only ADC with four positive Phase 3 trials in HER2-negative metastatic breast cancer (mBC). The use of Trodelvy plus pembrolizumab in patients with first-line PD-L1+ metastatic TNBC and Trodelvy as monotherapy in patients with first-line metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors are investigational, and the safety and efficacy of these uses have not been established. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About Triple-Negative Breast Cancer TNBC is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for approximately 15% of all breast cancers. TNBC disproportionally impacts younger, premenopausal, and Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2 expression. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of mBC. About Trodelvy Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect. Trodelvy is currently approved in more than 60 countries for second-line or later metastatic triple-negative breast cancer (TNBC) and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC). Outside of Europe, Gilead has submitted supplemental applications to the U.S. Food and Drug Administration (FDA) for approval of Trodelvy based on the ASCENT-03 and ASCENT-04 studies. Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity. U.S. INDICATIONS FOR TRODELVY TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with: Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. U.S. IMPORTANT SAFETY INFORMATION FOR TRODELVY BOXED WARNING: NEUTROPENIA AND DIARRHEA TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay. TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses. CONTRAINDICATIONS Severe hypersensitivity reaction to TRODELVY. WARNINGS AND PRECAUTIONS Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI. Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments. Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions. Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting. Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function. Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose. ADVERSE REACTIONS In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%). In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes. In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes. DRUG INTERACTIONS UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY. UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY. Please see full Prescribing Information, including BOXED WARNING. About Gilead and Kite Oncology Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving Trodelvy; uncertainties relating to regulatory applications and related filing and approval timelines, including such as the pending applications for Trodelvy in 1L mTNBC and potential applications for programs and/or indications currently under evaluation, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Trodelvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. U.S. Prescribing Information for Trodelvy, including BOXED WARNING, is available at www.gilead.com. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). View source version on businesswire.com: https://www.businesswire.com/news/home/20260521052840/en/ Priscilla White, Media
Public_affairs@gilead.com Jacquie Ross, Investors
investor_relations@gilead.com Original: Gilead Receives CHMP Positive Opinion for Trodelvy® in First-Line Metastatic Triple-Negative Breast Cancer for Patients Not Candidates for PD-(L)1 Inhibitors

New ASCO and EHA 2026 Data Demonstrate Gilead and Kite’s Momentum Across Antibody-Drug Conjugates and Cell Therapy in OncologyMay 21, 2026 5:00 PM
Business Wire – ASCO Presentations on Trodelvy® in First-line Metastatic Triple-Negative Breast Cancer and Anito-cel in Relapsed or Refractory Multiple Myeloma Build Toward Potential Commercial Launches – – EHA Updates Include Durability of KITE-753, Kite’s Enhanced DuoCore™ CAR T-cell Therapy – Gilead Sciences, Inc. (Nasdaq: GILD) today announced that together with Kite, a Gilead company, it will present more than 25 abstracts, including six oral presentations, at the 2026 ASCO Annual Meeting (May 29 – June 2) and the 2026 EHA Congress (June 11 – 14). These presentations underscore the increasing diversity of Gilead’s oncology portfolio and pipeline reflecting a growing body of evidence across both solid tumors and hematologic malignancies. Collectively, the data demonstrate Gilead and Kite’s leadership in antibody-drug conjugates (ADCs) and CAR T-cell therapy. Key presentations support continued momentum ahead of near-term potential launch opportunities, including new data analyses for Trodelvy® (sacituzumab govitecan-hziy) in first-line metastatic triple-negative breast cancer (mTNBC) and anitocabtagene autoleucel (anito-cel), an investigational agent for relapsed or refractory multiple myeloma (RRMM). Together with abstracts addressing earlier-stage innovation, manufacturing experience and real-world evidence, these data highlight a portfolio that is increasingly positioned to deliver durable impact at scale. “We are at a pivotal inflection point in the evolution of our oncology portfolio, with late-stage programs advancing alongside a rapidly maturing pipeline,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “The data we are presenting at ASCO and EHA highlight the trajectory we are building across antibody-drug conjugates and cell therapy, while reinforcing the clinical, manufacturing and operational foundation to sustain long-term leadership in oncology and deliver meaningful advances for people living with cancer.” Key presentations at ASCO include: ASCENT-04 and ASCENT-03 Analyses: Gilead will present new analyses during oral sessions from the Phase 3 ASCENT-04 and ASCENT-03 studies that further define the clinical profile of Trodelvy with or without Keytruda® (pembrolizumab) in first-line mTNBC, including evaluation of progression-free survival after next-line treatment (PFS2) in each study (Abstract #s LBA1000 and 1001). PFS2 is a measure that provides important context around durable, long-term clinical effect beyond the first progression. The ASCENT-04 PFS2 data for Trodelvy plus Keytruda will be shared as part of ASCO’s press program. Anito-cel Clinical Trial Manufacturing: Kite will present for the first time data on the anito-cel clinical trial manufacturing experience in patients with RRMM with at least one prior therapy or newly diagnosed MM from the Phase 3 iMMagine-3 and the Phase 2 GEM-AnitoFIRST study in collaboration with the GEM/PETHEMA Foundation, respectively. These findings highlight manufacturing consistency and operational execution supporting broader clinical development (Abstract #2550). CAR T for the Treatment of Recurrent Glioblastoma: Research collaborators at the University of Pennsylvania Perelman School of Medicine will deliver an oral presentation featuring updated Phase 1 data exploring CAR T-cell therapy in recurrent glioblastoma, reflecting continued progress in advancing cell therapy approaches in solid tumors (Abstract #2013). Key presentations at EHA include: KITE-753 Phase 1 Study: Updated Phase 1 results for KITE-753, Kite’s enhanced DuoCore™ CAR T-cell therapy for relapsed/refractory B-cell lymphoma, showing encouraging safety and durability of efficacy results that support its continued development (Abstract #4208619). Summary of Presentations Accepted abstracts at the 2026 ASCO Annual Meeting can be found at www.ASCO.org and include: Title Abstract Details Breast Cancer Progression-free survival after next line of treatment (PFS2) and subsequent therapies (subs tx) in the ASCENT-04 study of participants (pts) with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan (SG) plus pembrolizumab (pembro) vs chemotherapy (chemo) plus pembro Abstract #LBA1000 Oral Presentation June 2, 2026 9:45 – 9:57 AM CDT Progression-free survival after next line of treatment (PFS2) and subsequent therapies (subs tx) in the ASCENT-03 study of participants (pts) with previously untreated metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan (SG) vs chemotherapy (chemo) Abstract #1001 Oral Presentation June 2, 2026 9:57 – 10:09 AM CDT ASCENT-04: Analysis of efficacy by biomarker subgroups with sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in participants (pts) with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC) Abstract #1013 Rapid Oral Presentation May 31, 2026 11:30 – 11:36 AM CDT ASCENT-03: Efficacy by biomarker subgroup with sacituzumab govitecan (SG) vs chemotherapy (chemo) in participants (pts) with previously untreated advanced triple-negative breast cancer (TNBC) who are not candidates for PD-(L)1 inhibitors (PD-[L]1i) Abstract #1014 Rapid Oral Presentation May 31, 2026 11:36 – 11:42 AM CDT Using ML to predict rapid progression for patients (pts) with HR+/HER2- metastatic breast cancer (mBC) treated with frontline (1L) CDK 4/6 inhibitors (CDK 4/6i) Abstract #1025 Poster Presentation June 1, 2026 1:30 – 4:30 PM CDT Subgroup analysis of participants (pts) with HER2 IHC0 in the ASCENT-07 study of sacituzumab govitecan (SG) vs chemotherapy in HR+/HER2- metastatic breast cancer (mBC) Abstract #1065 Poster Presentation June 1, 2026 1:30 – 4:30 PM CDT Early deviations from guideline-concordant care in triple-negative breast cancer: A patient-reported analysis Abstract #e13528 Online Publication Only May 21, 2026 4:00 PM CDT Real-world utilization of a patient-centric symptom management guide for metastatic breast cancer   Abstract #e23403 Online Publication Only May 21, 2026 4:00 PM CDT Ovarian Cancer NAPISTAR 1-01: Results of phase 1 dose escalation of monotherapy with TUB-040, a novel NaPi2b-targeting exatecan ADC, in patients (pts) with platinum-resistant ovarian cancer (PROC) Abstract #5513 Rapid Oral Presentation May 30, 2026 8:36 – 8:42 AM CDT Multiple Myeloma Anitocabtagene autoleucel (anito-cel) clinical trial manufacturing experience in patients with relapsed/refractory (RR) or newly diagnosed (ND) multiple myeloma (MM)** Abstract #2550 Poster Presentation May 30, 2026 1:30 – 4:30 PM CDT Glioblastoma Updated overall survival, safety, and neurologic function outcomes from a phase 1 trial of bivalent chimeric antigen receptor (CAR) T-cell therapy in recurrent glioblastoma (GBM)*** Abstract #2013 Rapid Oral Presentation May 31, 2026 5:06 – 5:12 PM CDT Large B-cell Lymphoma KITE-753: A phase 2 study of an autologous anti-CD19/CD20 CAR T-cell therapy in CAR-naive patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) Abstract #TPS7098 Poster Presentation June 1, 2026 9:00 AM – 12:00 PM CDT Long-term real-world outcomes of axicabtagene ciloleucel (axi-cel) in relapsed/refractory (R/R) large B-cell lymphoma (LBCL)   Abstract #7028 Poster Presentation June 1, 2026 9:00 AM – 12:00 PM CDT CAR T-cell Therapy Resource Utilization Real-world healthcare resource utilization (HCRU) following chimeric antigen receptor (CAR) T-cell therapy in U.S. patients treated in new authorized treatment centers (ATCs) without FACT accreditation Abstract #e19515 Online Publication Only May 21, 2026 4:00 PM CDT   *In collaboration with Viver Health **In collaboration with the GEM/PETHEMA Foundation ***Collaborative study with the University of Pennsylvania Perelman School of Medicine Accepted abstracts at the 2026 EHA Congress highlight Kite’s expertise in CAR T-cell therapy and include: Title Abstract Details Large B-cell Lymphoma A Phase 1 Study of KITE-753 in Patients (Pts) With Relapsed/Refractory (R/R) B-Cell Lymphoma: Updated Safety and Efficacy Results Abstract #4208619 Poster Presentation June 13, 2026 6:45 – 7:45 PM CEST Axicabtagene Ciloleucel as Second-Line Treatment in Patients With Late-Relapsed Large B-Cell Lymphoma: Interim Analysis of the LATE-R Clinical Trial From the Spanish Lymphoma Group GELTAMO* Abstract #4207969 Poster Presentation June 12, 2026 6:45 – 7:45 PM CEST Clinical and Economic Outcomes by Risk Group Among First-Line Patients With Large B-Cell Lymphoma in the United States—SEER-Medicare Data Analysis Abstract #4210325 Publication Only May 12, 2026 Real-World (RW) Treatment Patterns and Survival Outcomes in Patients (Pts) With Newly Diagnosed High-Risk (HR) Large B-Cell Lymphoma (LBCL) Abstract #4206903 Poster Presentation June 12, 2026 6:45 – 7:45 PM CEST International Expert Consensus on Real-World CAR T-Cell Eligibility in Large B-Cell Lymphomas: An E-Delphi Study Abstract #4206912 Poster Presentation June 12, 2026 6:45 – 7:45 PM CEST Global Variation in CAR T-Cell Therapy Practice Patterns for LBCL: Quantitative Research Findings Abstract #4210262 Publication Only May 12, 2026 Axicabtagene Ciloleucel for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Brazil: The Impact of CAR T-Cell Therapy Wait Time and Treatment Sequencing Abstract #4210270 Publication Only May 12, 2026 Cost-Effectiveness of Axicabtagene Ciloleucel for Treating Taiwanese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and High-Grade B-Cell Lymphoma After First-Line Treatment Abstract #4209065 Poster Presentation June 13, 2026 6:45 – 7:45 PM CEST Cost-Effectiveness of Axicabtagene Ciloleucel in Taiwanese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Primary Mediastinal B-Cell Lymphoma After Two Lines of Systemic Therapy Abstract #4207302 Poster Presentation June 12, 2026 6:45 – 7:45 PM CEST Mantle Cell Lymphoma Biologic Correlates of Long-Term Response After Brexucabtagene Autoleucel Therapy in Mantle Cell Lymphoma: Product Phenotype, PK, and Baseline Features Abstract #4208752 Poster Presentation June 13, 2026 6:45 – 7:45 PM CEST Acute Lymphoblastic Leukemia Cost-Effectiveness Analysis of Brexucabtagene Autoleucel in Adults With Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukaemia in Singapore Abstract #4209064 Poster Presentation June 13, 2026 6:45 – 7:45 PM CEST Non-Hodgkin Lymphoma Follow-Up-Time-Adjusted Non-Relapse Mortality (NRM) in Patients With Non-Hodgkin Lymphoma Following Chimeric Antigen Receptor (CAR) T-Cell Therapy Within Clinical Trials Abstract #4208663 Poster Presentation June 13, 2026 6:45 – 7:45 PM CEST Multiple Myeloma Anitocabtagene Autoleucel Clinical Trial Manufacturing Experience in Patients With Relapsed/Refractory or Newly Diagnosed Multiple Myeloma** Abstract #4209802 Publication Only Cell Therapy Healthcare Resource Utilization CAR T Cell Therapy in Clinical Routine: Quantification of Real-World Hospital Resource Use Across CAR T Care Pathway in Germany Abstract #4207303 Poster Presentation June 12, 2026 6:45 – 7:45 PM CEST   *Collaborative study with the Spanish Lymphoma Group GELTAMO **In collaboration with the GEM/PETHEMA Foundation The use of Trodelvy plus Keytruda in patients with first-line PD-L1+ metastatic TNBC and Trodelvy as monotherapy in patients with first-line metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors are investigational, and the safety and efficacy of these uses have not been established. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About Trodelvy Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect. Trodelvy is currently approved in more than 60 countries for second-line or later metastatic triple-negative breast cancer (TNBC) and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC). Outside of Europe, Gilead has submitted supplemental applications to the U.S. Food and Drug Administration (FDA) for approval of Trodelvy based on the ASCENT-03 and ASCENT-04 studies. Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity. About Anito-cel Anitocabtagene autoleucel (anito-cel, previously ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in relapsed or refractory multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. The small, D-Domain binder potentially enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the potential elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration. About KITE-753 KITE-753 is an investigational, bicistronic autologous CAR T-cell therapy engineered to potentially overcome tumor antigen heterogeneity and may prevent relapse. The KITE DuoCore™ construct uniquely combines anti-CD19 and anti-CD20 targeting with dual co-stimulation (CD28 and 4-1BB). KITE-753 utilizes a novel manufacturing process, aiming to preserve T-cell fitness. U.S. INDICATIONS FOR TRODELVY TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with: Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. U.S. IMPORTANT SAFETY INFORMATION FOR TRODELVY BOXED WARNING: NEUTROPENIA AND DIARRHEA TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay. TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses. CONTRAINDICATIONS Severe hypersensitivity reaction to TRODELVY. WARNINGS AND PRECAUTIONS Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI. Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments. Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions. Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting. Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function. Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose. ADVERSE REACTIONS In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%). In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes. In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes. DRUG INTERACTIONS UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY. UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY. Please see full Prescribing Information, including BOXED WARNING. About Gilead and Kite Oncology Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving anito-cel, sacituzumab govitecan-hziy and KITE-753 (such as ASCENT-03, ASCENT-04, iMMagine-3 and GEM-AnitoFIRST); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Trodelvy, Gilead, the Gilead logo, Kite and the Kite logo are trademarks of Gilead Sciences, Inc., or its related companies. U.S. Prescribing Information for Trodelvy, including BOXED WARNING, is available at www.gilead.com. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). View source version on businesswire.com: https://www.businesswire.com/news/home/20260520344508/en/ Priscilla White, Media
public_affairs@gilead.com Jacquie Ross, Investors
investor_relations@gilead.com Original: New ASCO and EHA 2026 Data Demonstrate Gilead and Kite’s Momentum Across Antibody-Drug Conjugates and Cell Therapy in Oncology

Gilead Sciences Completes Acquisition of Tubulis Further Strengthening Oncology PortfolioMay 21, 2026 9:30 AM
Business Wire – Acquisition Builds on Gilead’s Leadership in Oncology with Potentially Best-in-Class Antibody-Drug Conjugate and Next Generation Platform – Gilead Sciences, Inc. (Nasdaq: GILD) today announced the successful completion of its previously announced acquisition of Tubulis GmbH, a private Germany-based, clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADCs). The acquisition brings Gilead next-generation ADC assets and a platform designed to maximize patient benefit through more selective delivery of diverse payloads to tumors. Tubulis’ technologies enable the development of unique ADCs with superior biophysical properties, capable of achieving robust on-tumor payload exposure that can translate to long-lasting anti-tumor activity. The addition of Tubulis’ lead asset, TUB-040, a NaPi2b-directed topoisomerase-I inhibitor (TOPO1i) ADC, which has demonstrated promising activity in platinum-resistant ovarian cancer, and TUB-030, a 5T4-directed ADC that is being investigated across various solid tumor types, complements Gilead’s existing ADC portfolio. “We look forward to welcoming the Tubulis team to Gilead and building on the significant progress they have made in advancing novel ADC technology for people living with cancer,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “Our two-year collaboration with Tubulis gave us strong conviction in their team, their programs and their technologies. We will now combine our strengths in service of providing new options for some of the most challenging forms of disease.” Under the terms of the agreement, Gilead acquired all the outstanding equity of Tubulis for $3.15 billion in upfront considerations on a cash-free, debt-free basis, and up to $1.85 billion in contingent milestone payments. The Tubulis team will continue to be based in Munich, Germany, establishing The Tubulis ADC Innovation Center. This new Center will be a hub for the team to continue building on its integrated discovery, manufacturing and clinical capabilities to advance next generation ADCs. About TUB-040 and the Tubutecan Technology TUB-040 is an investigational antibody-drug conjugate (ADC) that targets NaPi2b, a protein expressed at high levels in several tumor types, including ovarian, lung, and endometrial cancer. TUB-040 utilizes the Tubutecan technology engineered to have eight chemotherapy payloads (topoisomerase-I inhibitor) attached to a stable, cleavable linker system that allows for potent tumor cell killing. This design allows TUB-040 to deliver the drug directly to cancer cells while limiting exposure to healthy tissue, improving the tolerability of the ADC compared to earlier ADC technologies. In early clinical studies, TUB-040 has shown encouraging anti-tumor activity with a manageable safety profile in patients with platinum-resistant ovarian cancer, as reported at ESMO 2025. It is currently being evaluated in an ongoing multicenter Phase I/IIa study in patients with platinum-resistant ovarian cancer and relapsed or refractory non-small cell lung cancer. About Gilead and Kite Oncology Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of Gilead and Tubulis and members of their respective senior management teams. In some cases, forward-looking statements can be identified by the use of words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “seek,” “may,” “plan,” “project,” “should,” “target,” “will,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, without limitation, statements regarding the transaction and related matters, prospective performance and opportunities, post-closing operations and the outlook for the companies’ businesses; the potential of Tubulis’s ADC programs and platform; The Tubulis ADC Innovation Center; and any assumptions underlying any of the foregoing. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: the effects of the transaction on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; the risk that, if the transaction is consummated, the businesses will not be integrated successfully and that other anticipated benefits from the transaction will not be realized; the impact of competitive products and pricing; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; transaction costs; actual or contingent liabilities; the risk that Gilead may not realize the expected benefits of this acquisition transaction; the ability of Gilead to advance their product pipeline and successfully commercialize product candidates following the acquisition; the ability of the parties to initiate and complete clinical trials involving such product candidates in the currently anticipated timelines or at all; the possibility of unfavorable results from one or more of such trials involving such product candidates; uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the U.S. Securities and Exchange Commission. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). View source version on businesswire.com: https://www.businesswire.com/news/home/20260520959712/en/ Priscilla White, Media
public_affairs@gilead.com Jacquie Ross, Investors
investor_relations@gilead.com Original: Gilead Sciences Completes Acquisition of Tubulis Further Strengthening Oncology Portfolio

Gilead Sciences and World Health Organization Expand Collaboration to Help Eliminate Visceral Leishmaniasis, a Fatal Parasitic DiseaseMay 21, 2026 3:30 AM
Business Wire - The disease remains a public health challenge with an estimated 50,000 to 90,000 new cases each year - Gilead Sciences, Inc. (Nasdaq: GILD) today announced a renewed five-year collaboration with the World Health Organization (WHO), committing funding, strategic support and product donations to accelerate progress toward eliminating visceral leishmaniasis (VL), also known as kala-azar. VL, the second deadliest parasitic disease after malaria, is a sandfly-borne illness that attacks internal organs and can be fatal if untreated. The expanded agreement aims to improve access to life-saving diagnostic services and treatment for some of the world's most vulnerable communities, with a sharpened focus on high-burden countries in East Africa. Gilead is committed to improving global health by advancing innovative treatments and partnering with organizations such as WHO to broaden access to medicines and help eliminate diseases like VL. "Ending visceral leishmaniasis is within reach because of sustained commitment and investment," said Daniel O'Day, Chairman and Chief Executive Officer, Gilead Sciences. "Through the work to expand access to diagnosis and treatment for the disease, we have already made significant progress in endemic regions. With this expanded collaboration and stronger focus on East Africa, we will accelerate progress toward elimination and help ensure more people can access the care they need to survive.” As part of this collaboration, Gilead will donate more than 400,000 vials of AmBisome® (amphotericin B) liposome for injection and $9.2 million in financial support through 2030. Gilead’s donations will support countries representing approximately 74% of the global VL burden, including Bangladesh, Ethiopia, Eritrea, India, Kenya, Nepal, Somalia, South Sudan, Sudan, Uganda and Yemen, with expanded support in Chad and Djibouti. "This agreement underscores the power of strategic partnerships in advancing global health priorities. Through our collaboration with Gilead Sciences, WHO is better equipped to support countries in accelerating the elimination of visceral leishmaniasis as a public health problem," said Dr Jeremy Farrar, Assistant Director-General, Health Promotion, Disease Prevention and Care, WHO. "Over the next five years, this collaboration will help expand access to essential tools, foster innovation, and reinforce health systems where the burden is greatest. It reflects our shared determination to translate commitment into measurable impact, ensuring that no community is left behind in the fight against neglected tropical diseases." Since the start of the elimination program in Southeast Asia in 2005, this longstanding partnership with WHO has helped reduce new cases of VL by more than 95% in that region, significantly lowering the overall disease burden. In 2023, Bangladesh achieved a major milestone, with WHO validating the elimination of VL as a public health problem. About Gilead’s Access & Health Equity Gilead is committed to advancing global health equity at scale, particularly for neglected diseases in low- and middle-income countries. Through sustained, multiyear approaches including partnerships, voluntary licensing, and targeted access initiatives, Gilead expands access to medicines, strengthens health systems, and addresses serious diseases affecting communities with the greatest unmet need. By fostering innovative collaborations, the company supports sustainable health outcomes worldwide. About Visceral Leishmaniasis Visceral leishmaniasis (VL), also known as kala-azar, is a severe parasitic disease endemic in approximately 80 countries worldwide and is the second deadliest parasitic disease after malaria. Transmitted through the bite of infected sandflies carrying the Leishmania parasite, VL attacks internal organs and can cause prolonged fever, weight loss, enlargement of the spleen and liver, and anemia, while increasing vulnerability to other life-threatening infections. If left untreated, VL is fatal in more than 95% of cases. It disproportionately affects people in some of the world's poorest regions and is closely linked to risk factors such as malnutrition, overcrowding, poor housing and sanitation, population displacement, environmental changes, weakened immune systems, and limited access to healthcare. About AmBisome® AmBisome® (amphotericin B) liposome for injection is indicated in the U.S. for the treatment of visceral leishmaniasis. In immunocompromised patients with VL treated with AmBisome®, relapse rates were high following initial clearance of parasites. AmBisome® is contraindicated in those patients who have demonstrated or have known hypersensitivity to amphotericin B deoxycholate or any other constituents of the product unless, in the opinion of the treating physician, the benefit of therapy outweighs the risk. Anaphylaxis has been reported with amphotericin B deoxycholate and other amphotericin B-containing drugs, including AmBisome®. If a severe anaphylactic reaction occurs, the infusion should be immediately discontinued and the patient should not receive further infusions of AmBisome®. See the full Prescribing Information for additional important safety information and recommended usage. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, jobcreation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. AmBisome, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. U.S. full Prescribing Information for AmBisome is available at www.gilead.com. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). View source version on businesswire.com: https://www.businesswire.com/news/home/20260521945977/en/ Elizabeth Baxter, Media
public_affairs@gilead.com Jacquie Ross, Investors
investor_relations@gilead.com Original: Gilead Sciences and World Health Organization Expand Collaboration to Help Eliminate Visceral Leishmaniasis, a Fatal Parasitic Disease

Gilead Prices $3 Billion of Senior Unsecured NotesMay 14, 2026 9:21 PM
Business Wire Gilead Sciences, Inc. (Nasdaq: GILD), a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, today announced the pricing of senior unsecured notes in an aggregate principal amount of $3 billion, in an underwritten, registered public offering, consisting of $500 million of 4.250% senior notes maturing in 2028, $1 billion of 4.400% senior notes maturing in 2029, $1 billion of 4.600% senior notes maturing in 2031 and $500 million of 4.900% senior notes maturing in 2034. The offering is expected to close on May 20, 2026, subject to customary closing conditions. Gilead intends to use the net proceeds from this offering for general corporate purposes, which may include funding for acquisitions, investments, strategic transactions or other business opportunities. Barclays Capital Inc., BofA Securities, Inc. and Citigroup Global Markets Inc. are acting as lead joint book-running managers in the offering. The offering of the securities is being made only by means of a prospectus supplement and the accompanying base prospectus, which is filed as part of Gilead’s effective shelf registration statement on Form S-3 (File No. 333-273745), copies of which may be obtained from: Barclays Capital Inc. c/o Broadridge Financial Solutions, 1155 Long Island Avenue Edgewood, NY 11717 (888) 603-5847 Email: barclaysprospectus@broadridge.com BofA Securities, Inc. NC1-022-02-25 201 North Tryon Street Charlotte, NC 28255 (800) 294-1322 Email: dg.prospectus_requests@bofa.com Citigroup Global Markets Inc. c/o Broadridge Financial Solutions, 1155 Long Island Avenue Edgewood, NY 11717 (800) 831-9146 Email: prospectus@citi.com An electronic copy of the prospectus supplement and the accompanying base prospectus and other documents Gilead has filed with the U.S. Securities and Exchange Commission (the “SEC”) may also be obtained at no charge at the SEC’s website at www.sec.gov. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the current market demand for these types of securities and the securities of Gilead; Gilead’s ability to consummate the offering in the currently anticipated timeframe or at all; the risk that Gilead’s planned investments may not achieve their intended benefits; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent quarterly reports, as filed with the SEC. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. View source version on businesswire.com: https://www.businesswire.com/news/home/20260514676730/en/ Ashleigh Koss, Media
public_affairs@gilead.com Jacquie Ross, Investors
investor_relations@gilead.com Original: Gilead Prices $3 Billion of Senior Unsecured Notes

Gilead Sciences to Present at Upcoming Second Quarter 2026 Investor ConferencesMay 1, 2026 6:00 AM
Business Wire
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its executives will be speaking at the following investor conferences:



BofA Securities Health Care Conference on Tuesday, May 12 at 2:20 PM Pacific Time



RBC Capital Markets Global Healthcare Conference on Tuesday, May 19 at 11:00 AM Eastern Time



Bernstein Annual Strategic Decisions Conference on Thursday, May 28 at 11:00 AM Eastern Time



Goldman Sachs Annual Global Healthcare Conference on Tuesday, June 9 at 1:20 PM Eastern Time



The live webcasts can be accessed at the company’s investors page at investors.gilead.com. The replays will be available for at least 30 days following the presentation.


About Gilead Sciences


Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.


For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter ( @Georgia Bard-GILEAD-5 or 1-650-574-3000.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260501262300/en/
Jacquie Ross, CFA – Investors

investor_relations@gilead.com


Original: Gilead Sciences to Present at Upcoming Second Quarter 2026 Investor Conferences

Gilead Sciences to Release First Quarter 2026 Financial Results on Thursday, May 7, 2026April 22, 2026 4:05 PM
Business Wire
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its first quarter 2026 financial results and guidance will be released on Thursday, May 7, 2026 after the market closes. At 4:30 p.m. Eastern Time that day, Gilead’s management will host a webcast to discuss the company’s first quarter 2026 financial results and provide a business update.


A live webcast will be available in the Investors section of www.gilead.com and will be archived there for one year.


About Gilead Sciences


Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.


For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter ( @Georgia Bard-GILEAD-5 or 1-650-574-3000.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260422191444/en/
Jacquie Ross, CFA – Investors

investor_relations@gilead.com


Original: Gilead Sciences to Release First Quarter 2026 Financial Results on Thursday, May 7, 2026

Gilead Receives All Required Regulatory Approvals for the Acquisition of Arcellx and Extends Tender OfferApril 17, 2026 8:30 AM
Business Wire
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that all required regulatory approvals have been obtained for its previously announced acquisition of Arcellx and that Gilead has extended the expiration of the tender offer to purchase all outstanding shares of common stock of Arcellx.


On April 13, 2026, the Australian Competition and Consumer Commission (ACCC) published its decision that the acquisition of Arcellx may be put into effect, subject to expiration of a 14-calendar day waiting period. Assuming that the ACCC’s determination remains unchallenged during this waiting period, the waiting period expires at 10:00 a.m., Eastern Time, on April 27, 2026. Additionally, the relevant review period for the Austrian competition authorities has expired. Accordingly, all required regulatory approvals for the transaction have been obtained, and the “Regulatory Approvals Condition” (as defined in the Offer to Purchase, dated March 6, 2026, relating to the offer) will be satisfied upon expiration of the 14-calendar day review period pursuant to Australian competition law.


The tender offer, which was previously scheduled to expire at 5:00 p.m., Eastern Time, on April 24, 2026, has been extended to expire at 5:00 p.m., Eastern Time, on April 27, 2026, and remains subject to the satisfaction or waiver of customary closing conditions, including the tender of a number of shares of Arcellx common stock that, together with shares already owned by Gilead, equals at least a majority of the then-outstanding Arcellx shares and other customary offer conditions.


The offer remains at a purchase price of (1) $115.00 per share, net to the seller in cash, without interest, subject to any withholding tax, plus (2) one contractual contingent value right (CVR), which represents the right to receive one contingent payment of $5.00 per CVR in cash, without interest, and subject to any withholding tax, payable on March 31, 2030, subject to cumulative worldwide sales of Arcellx’s anitocabtagene autoleucel (anito-cel) product exceeding $6.0 billion on or prior to December 31, 2029.


Computershare Trust Company, N.A., the depositary and paying agent for the tender offer, has advised Gilead that, as of 4:00 p.m., Eastern Time, on April 16, 2026, approximately 10,271,823 shares have been validly tendered and not validly withdrawn in the tender offer, representing approximately 17.5% of the outstanding shares as of such date and time. Holders that have previously tendered their shares do not need to re-tender their shares or take any other action in response to the extension of the tender offer. Questions or requests for assistance may be directed to Innisfree M&A Incorporated, the information agent for the tender offer, by calling toll free (877) 800-5182.


About Gilead Sciences


Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.


Forward-Looking Statements


This communication contains forward-looking statements related to Gilead, Arcellx and the acquisition of Arcellx by Gilead that are subject to risks, uncertainties, and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of Gilead and Arcellx and members of their respective senior management teams. In some cases, forward-looking statements can be identified by the use of words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “seek,” “may,” “plan,” “project,” “should,” “target,” “will,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, without limitation, statements regarding the transaction and related matters, prospective performance and opportunities, post-closing operations and the outlook for the companies’ businesses, including, without limitation, filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability to satisfy the various closing conditions and complete the transaction; and any assumptions underlying any of the foregoing. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Arcellx’s stockholders will tender their stock in the offer; the possibility that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of the transaction on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; the risk that, if the transaction is consummated, the businesses will not be integrated successfully and that other anticipated benefits from the transaction will not be realized; any negative effects on the existing collaboration between Arcellx and Gilead that may result from the announcement of a transaction, or the failure to complete the transaction; the risk that the milestone associated with the CVR may not be achieved and that holders of CVRs may not receive payments in respect thereof; the impact of competitive products and pricing; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; transaction costs; actual or contingent liabilities; and other risks and uncertainties detailed from time to time in the companies’ periodic reports filed with the U.S. Securities and Exchange Commission (the “SEC”), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, as well as the Schedule 14D-9 filed by Arcellx and the Schedule TO and related tender offer documents filed by Gilead and Ravens Sub, Inc. (“Purchaser”), a wholly owned subsidiary of Gilead. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.


Additional Information and Where to Find It


In connection with the proposed acquisition of Arcellx, Gilead caused Purchaser to commence a tender offer to purchase all of the outstanding shares of common stock of Arcellx. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities of Arcellx, nor is it a substitute for any tender offer materials that Gilead, Ravens Sub, Inc. or Arcellx has filed or will file with the SEC. A solicitation and an offer to buy securities of Arcellx is being made only pursuant to an offer to purchase and related materials that Gilead has filed with the SEC. Gilead has filed a Tender Offer Statement on Schedule TO with the SEC, and Arcellx has filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. ARCELLX’S STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 BECAUSE THEY CONTAIN IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. The Offer to Purchase, the related letter of transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement on Schedule 14D-9, have been sent to all stockholders of Arcellx at no expense to them. The Tender Offer Statement on Schedule TO, the Solicitation/Recommendation Statement on Schedule 14D-9 and other related documents are made available for free at the SEC’s website at www.sec.gov. Additional copies may be obtained for free by contacting Gilead or Arcellx. Free copies of these materials and certain other offering documents are available from Gilead by mail to Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, attention: Investor Relations, by phone at 1-800-GILEAD-5 or 1-650-574-3000, or by directing requests for such materials to the information agent for the offer. Investors and security holders of Arcellx may also obtain, free of charge, the Solicitation/Recommendation Statement on Schedule 14D-9 and other related documents that Arcellx has filed with or furnished to the SEC under the “Financials” section of Arcellx’s website at https://ir.arcellx.com/financials/sec-filings/default.aspx.


In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Gilead and Arcellx file annual, quarterly and current reports, proxy statements and other information with the SEC. Gilead’s and Arcellx’s filings with the SEC are also available for free to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.


Gilead, Kite, and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260417916113/en/
Gilead

Ashleigh Koss, Media

public_affairs@gilead.com


Jacquie Ross, Investors

investor_relations@gilead.com


Original: Gilead Receives All Required Regulatory Approvals for the Acquisition of Arcellx and Extends Tender Offer

The BBC mentions there is HIV in the vaxx...
The BBC mentions there is HIV in the vaxx... pic.twitter.com/3Leyf99CbP— FAKEY FAKEY ✟ (@4winds_) August 11, 2023 $GILD

$GILD "Illinois Governor JB Pritzker signed House Bill 106, decriminalizing spreading HIV

“To Illinois after a Governor Pritzker signed a new law that decriminalizes spreading HIV. Now the new policy officially repeals a law that was passed back in 1986”

The signed by Governor Pritzker eliminated the HIV-specific criminal statute that made it a felony for someone who knew they had HIV to engage in activities like unprotected sex, sharing needles, or donating blood without disclosure" Illinois Governor JB Pritzker signed House Bill 106, decriminalizing spreading HIV

“To Illinois after a Governor Pritzker signed a new law that decriminalizes spreading HIV. Now the new policy officially repeals a law that was passed back in 1986”

The signed by Governor… pic.twitter.com/gIbhxmBUz8— Wall Street Apes (@WallStreetApes) April 13, 2026

Tempus AI Shares Gain After Expanded Partnership with GileadApril 10, 2026 9:34 AM
IH Market News
Shares of Tempus AI Inc. (NASDAQ:TEM) climbed 3% on Friday morning after the company announced an expanded multi-year collaboration with Gilead Sciences Inc. (NASDAQ:GILD), aimed at supporting the development of Gilead’s oncology pipeline.The new agreement grants Gilead enterprise-wide access to Tempus’ AI-powered Lens platform, which offers expanded datasets across various disease areas along with dedicated analytical support. Gilead has already been utilizing Tempus’ anonymized multimodal data for oncology research, including applications in clinical trial design, indication selection, biomarker development, health outcomes analysis, and real-world evidence generation.As part of the enhanced partnership, Gilead will use Tempus’ multimodal data resources to generate insights intended to guide clinical decision-making in cancer care.“By providing access to the Tempus multimodal data library, we are empowering the Gilead team to further fuel its R&D engine with AI-driven insights,” said Ryan Fukushima, CEO of Tempus Data & Apps. “We are thrilled to expand this collaboration, offering the multimodal depth necessary to uncover critical biological insights.”Tempus AI is a technology firm focused on applying artificial intelligence to advance precision medicine through its data and analytics platforms.

Original: Tempus AI Shares Gain After Expanded Partnership with Gilead

Gilead Extends Tender Offer to Acquire ArcellxApril 1, 2026 4:13 PM
Business Wire
Gilead Sciences, Inc. (Nasdaq: GILD) today extended the expiration of the tender offer to purchase all outstanding shares of common stock of Arcellx. The offer remains at a purchase price of (1) $115.00 per share, net to the seller in cash, without interest, subject to any withholding tax, plus (2) one contractual contingent value right (CVR), which represents the right to receive one contingent payment of $5.00 per CVR in cash, without interest, and subject to any withholding tax, payable on March 31, 2030, subject to cumulative worldwide sales of Arcellx’s anitocabtagene autoleucel (anito-cel) product exceeding $6.0 billion on or prior to December 31, 2029.


The tender offer, which was previously scheduled to expire at one minute after 11:59 p.m., Eastern Time, on April 2, 2026, has been extended to expire at 5:00 p.m., Eastern Time, on April 24, 2026. The transaction is anticipated to close during the second quarter of 2026, subject to the satisfaction or waiver of customary closing conditions, including the tender of a number of shares of Arcellx common stock that, together with shares already owned by Gilead, equals at least a majority of the then-outstanding Arcellx shares, the receipt of regulatory approvals and other customary offer conditions.


Computershare Trust Company, N.A., the depositary and paying agent for the tender offer, has advised Gilead that, as of 5:00 p.m., Eastern Time, on March 31, 2026, approximately 4,389,763 shares have been validly tendered and not validly withdrawn in the tender offer, representing approximately 7.5% of the outstanding shares as of such date and time. Holders that have previously tendered their shares do not need to re-tender their shares or take any other action in response to the extension of the tender offer. Questions or requests for assistance may be directed to Innisfree M&A Incorporated, the information agent for the tender offer, by calling toll free (877) 800-5182.


About Gilead Sciences


Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.


Forward-Looking Statements


This communication contains forward-looking statements related to Gilead, Arcellx and the acquisition of Arcellx by Gilead that are subject to risks, uncertainties, and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of Gilead and Arcellx and members of their respective senior management teams. In some cases, forward-looking statements can be identified by the use of words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “seek,” “may,” “plan,” “project,” “should,” “target,” “will,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, without limitation, statements regarding the transaction and related matters, prospective performance and opportunities, post-closing operations and the outlook for the companies’ businesses, including, without limitation, filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability to satisfy the various closing conditions and complete the transaction; and any assumptions underlying any of the foregoing. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Arcellx’s stockholders will tender their stock in the offer; the possibility that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of the transaction on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; the risk that, if the transaction is consummated, the businesses will not be integrated successfully and that other anticipated benefits from the transaction will not be realized; any negative effects on the existing collaboration between Arcellx and Gilead that may result from the announcement of a transaction, or the failure to complete the transaction; the risk that the milestone associated with the CVR may not be achieved and that holders of CVRs may not receive payments in respect thereof; the impact of competitive products and pricing; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; transaction costs; actual or contingent liabilities; and other risks and uncertainties detailed from time to time in the companies’ periodic reports filed with the U.S. Securities and Exchange Commission (the “SEC”), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, as well as the Schedule 14D-9 filed by Arcellx and the Schedule TO and related tender offer documents filed by Gilead and Ravens Sub, Inc. (“Purchaser”), a wholly owned subsidiary of Gilead. All forward-looking statements are based on information currently available to Gilead, and Gilead assume no obligation and disclaim any intent to update any such forward-looking statements.


Additional Information and Where to Find It


In connection with the proposed acquisition of Arcellx, Gilead caused Purchaser to commence a tender offer to purchase all of the outstanding shares of common stock of Arcellx. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities of Arcellx, nor is it a substitute for any tender offer materials that Gilead, Ravens Sub, Inc. or Arcellx has filed or will file with the SEC. A solicitation and an offer to buy securities of Arcellx is being made only pursuant to an offer to purchase and related materials that Gilead has filed with the SEC. Gilead has filed a Tender Offer Statement on Schedule TO with the SEC, and Arcellx has filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. ARCELLX’S STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 BECAUSE THEY CONTAIN IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. The Offer to Purchase, the related letter of transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement on Schedule 14D-9, have been sent to all stockholders of Arcellx at no expense to them. The Tender Offer Statement on Schedule TO, the Solicitation/Recommendation Statement on Schedule 14D-9 and other related documents are made available for free at the SEC’s web site at www.sec.gov. Additional copies may be obtained for free by contacting Gilead or Arcellx. Free copies of these materials and certain other offering documents are available from Gilead by mail to Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, attention: Investor Relations, by phone at 1-800-GILEAD-5 or 1-650-574-3000, or by directing requests for such materials to the information agent for the offer. Investors and security holders of Arcellx may also obtain, free of charge, the Solicitation/Recommendation Statement on Schedule 14D-9 and other related documents that the Company has filed with or furnished to the SEC under the “Financials” section of Arcellx’s website at https://ir.arcellx.com/financials/sec-filings/default.aspx.


In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Gilead and Arcellx file annual, quarterly and current reports, proxy statements and other information with the SEC. Gilead’s and Arcellx’s filings with the SEC are also available for free to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.


Gilead, Kite, and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

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Gilead

Ashleigh Koss, Media

public_affairs@gilead.com


Jacquie Ross, Investors

investor_relations@gilead.com


Original: Gilead Extends Tender Offer to Acquire Arcellx

Gilead Sciences to Acquire Ouro Medicines to Advance First in Class T Cell Engager Program for Autoimmune DiseasesMarch 23, 2026 6:15 PM
Business Wire
-- Acquisition Adds Clinical Stage Bispecific BCMAxCD3 T Cell Engager with Potential for Durable Immune Reset to Gilead’s Inflammation Portfolio --


-- Gilead Intends to Enter into a Strategic Collaboration with Galapagos on the Ouro Portfolio of Medicines --


Gilead Sciences, Inc. (Nasdaq: GILD) announced today it has entered into a definitive agreement to acquire Ouro Medicines, a privately held biotechnology company focused on developing T cell engager therapies for autoimmune diseases.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260323998270/en/
The acquisition adds OM336 (gamgertamig), a clinical-stage BCMAxCD3 T cell engager, to Gilead’s growing inflammation portfolio. OM336 is designed to enable rapid and deep B cell depletion following a limited subcutaneously administered treatment course. In ongoing Phase 1/2 clinical studies, OM336 has demonstrated transformative efficacy and a differentiated safety profile after a single treatment cycle in severe antibody-mediated orphan diseases including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP). Gamgertamig has been granted both Fast Track and Orphan Drug Designation by the U.S. FDA for the treatment of AIHA and ITP and is expected to enter registrational studies in 2027.


“This acquisition underscores our commitment to advancing transformative therapies for people living with serious autoimmune diseases,” said Dietmar Berger, MD, PhD, Chief Medical Officer of Gilead. “BCMA is a validated target with emerging data demonstrating potentially transformative outcomes in autoimmune diseases. BCMA targeted T cell engagers represent a differentiated approach with the potential to induce durable disease control. This novel framework complements our expanding inflammation pipeline and reflects our strategy to invest in innovative science that may redefine standards of care.”


BCMA-targeted T cell engagers are being investigated as a precision approach for severe inflammatory and autoimmune diseases by eliminating pathogenic B cells and plasma cells. By redirecting a patient’s own T cells toward BCMA-expressing plasma cells, clinical data suggests these agents may reduce inflammation, improve organ-level disease, and, in some cases, enable an immune reset marked by durable, drug-free remission without ongoing immunosuppression. T cell engagers represent an important modality for patients alongside Gilead’s portfolio of CAR-T assets.


“From the outset, we saw the potential for gamgertamig to redefine the standard of care for immune-mediated diseases,” said Jaideep Dudani, PhD, CoFounder and Chief Executive Officer of Ouro Medicines. “Since then, we’ve taken meaningful steps to advance that vision, with multiple trials now underway. With support from Gilead and Galapagos, we can build on the strong early foundation—leveraging a proven track record in late stage development, launch, and commercialization to accelerate our programs and help deliver on the promise gamgertamig holds for patients with immune-mediated diseases, following our initial collaboration with Keymed Biosciences.”


Terms of the Transaction


Under the terms of the agreement Gilead will acquire all of the outstanding equity of Ouro Medicines for a total of $1,675 million in upfront cash consideration, subject to customary adjustments, which is payable at closing, and up to $500 million in contingent milestone payments. Closing of the transaction is subject to expiration or termination of certain regulatory filings and other customary conditions.


Strategic Collaboration with Galapagos


Gilead is currently in advanced discussions with Galapagos with respect to a potential research and development collaboration on the acquired Ouro Medicines assets. The arrangement between Gilead and Galapagos is contemplated to include the following key terms:



Galapagos would pay 50% of the upfront consideration and 50% of any contingent milestone payments payable to Ouro Medicines’ shareholders.



Galapagos would absorb substantially all of Ouro Medicines’ operating assets and retain its employees.



Gilead and Galapagos would collaborate on the development of OM336, with Galapagos responsible for development costs through initiation of registrational studies. Registrational study costs would be shared equally between the parties.



Gilead would retain sole worldwide commercialization rights (other than in Greater China where Keymed Biosciences has existing commercialization rights) and Gilead would pay Galapagos royalties of 20%-23% of net sales.



Amended legacy Galapagos Option License and Collaboration Agreement (“OLCA”) to allow for up to $500 million of Galapagos’ current cash to be used freely by Galapagos, including up to $150 million for potential share repurchases.



Centerview Partners LLC and TD Cowen are acting as financial advisors to Gilead. Goldman Sachs & Co. LLC is acting as the exclusive financial advisor to Ouro Medicines. Morgan Stanley & Co., LLC is acting as financial advisor to Galapagos. Covington & Burling LLP, Mayer Brown LLP, and Arnold & Porter Kaye Scholer LLP are serving as legal counsel to Gilead. Goodwin Procter LLP is serving as legal counsel to Ouro Medicines. Paul Weiss LLP and Linklaters LLP are serving as legal counsel to Galapagos.


About OM336


OM336 is an investigational BCMAxCD3 bispecific T cell engager for the treatment of autoantibodies driven immune-mediated disease. OM336 has been granted Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration for certain autoimmune diseases. OM336 is under an open IND in the U.S. and is expected to enter registrational studies in 2027. OM336 is in-licensed by Ouro Medicines from Keymed Biosciences, which owns the rights to develop the program in Greater China.


About Gilead Sciences


Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.


About Ouro Medicines


Ouro Medicines is a clinical stage biotechnology company dedicated to developing immune reset therapeutics for people living with chronic immune-mediated diseases. Ouro’s approach is focused on leveraging T cell engagers in B cell-mediated diseases to achieve immune resets that create durable remissions without ongoing immunosuppression. Based in San Francisco and launched in 2025, Ouro was founded by Monograph Capital in partnership with GSK. Ouro is also backed by leading investors TPG, NEA and Norwest. For more information visit www.ouromedicines.com or follow us on LinkedIn.


Gilead Forward-Looking Statements


This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Ouro Medicines to complete the acquisition transaction in a timely manner or at all; the possibility that various closing conditions for the acquisition transaction may not be satisfied or waived, including the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the acquisition transaction; uncertainties relating to the timing or outcome of any filings and approvals relating to the acquisition transaction; the ability of Gilead to negotiate and enter into the proposed collaboration with Galapagos, including on the terms described herein and in a timely manner or at all; difficulties or unanticipated expenses in connection with integrating the companies, including the effects of the acquisition transaction and the proposed collaboration on relationships with employees, other business partners or governmental entities; the risk that Gilead may not realize the expected benefits of this acquisition transaction; the ability of Gilead to advance their product pipeline and successfully commercialize product candidates following the acquisition; the ability of the parties to initiate and complete clinical trials involving such product candidates in the currently anticipated timelines or at all; the possibility of unfavorable results from one or more of such trials involving such product candidates; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that FDA may not approve any such product candidates in the anticipated indications or on the timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use;; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.


Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.


For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).

View source version on businesswire.com: https://www.businesswire.com/news/home/20260323998270/en/
Gilead Contacts:



Jessica Smith, Media

public_affairs@gilead.com
Jacquie Ross, Investors

investor_relations@gilead.com
Ouro Medicines Contact:



FGS Global

ouro@fgsglobal.com


Original: Gilead Sciences to Acquire Ouro Medicines to Advance First in Class T Cell Engager Program for Autoimmune Diseases

Combination Therapies Reshape Oncology: A $748B Market Shifts Standard of CareMarch 19, 2026 10:00 AM
PR Newswire (US)

Issued on behalf of Oncolytics Biotech Inc.VANCOUVER, BC, March 19, 2026 /PRNewswire/ -- USANewsGroup.com News Commentary — The global oncology market is valued at $279.98 billion in 2026 and is on track to reach $748.17 billion by 2035[1], a structural realignment driven by the shift from single-agent treatments toward synergistic combination platforms and next-gen cell therapies. The immuno-oncology segment alone is projected to expand from $65.22 billion in 2025 to $170.19 billion by 2032[2], as a wave of combination therapy approvals converts tumors once resistant to immunotherapy into viable targets. Institutions are positioning for this shift through companies like Oncolytics Biotech (NASDAQ: ONCY), Gilead Sciences (NASDAQ: GILD), enGene Holdings (NASDAQ: ENGN), TScan Therapeutics (NASDAQ: TCRX), and Day One Biopharmaceuticals (NASDAQ: DAWN) (soon to be Servier), which are each advancing translational data or near-term regulatory milestones in the 2026 cycle.Goldman Sachs has projected 2026 will be a record-breaking year for biopharma dealmaking, with pharma and biotech companies remaining the primary target as a patent cliff looms which could result in the loss of hundreds of billions in revenue[3]. This structural shift creates a window for companies with asymmetric upside in high-value solid tumor markets, as the FDA's expanded accelerated approval framework—now covering gene therapies and next-generation combination regimens—compresses the timeline from translational data to commercial launch, making regulatory milestones the primary value driver for the 2026 immuno-oncology investment cycle[4].             Oncolytics Biotech (NASDAQ: ONCY) is presenting new mechanistic and translational data at the American Association for Cancer Research (AACR) Annual Meeting in San Diego this April, data that adds scientific depth to the company's push into some of cancer's hardest-to-treat corners.The two abstracts, drawn from the AWARE-1 breast cancer study and the GOBLET gastrointestinal cancer trial, both center on the same question: can pelareorep, the company's lead drug, make tumors more vulnerable to immunotherapy? The short answer, based on these findings, appears to be yes. In AWARE-1, biopsies showed pelareorep triggering the formation of tertiary lymphoid structures, essentially localized immune hubs that help the body mount a sustained attack on cancer cells.Tumors that would otherwise stay "cold" and invisible to the immune system showed signs of becoming "hot." In GOBLET Cohort 1, patients with pancreatic cancer who showed early immune activation after four weeks on a pelareorep-based regimen lived longer without their disease progressing than those who did not, 7.5 months compared to 5.6 months. That same treatment combination previously posted a 62% objective response rate in first-line pancreatic cancer patients, more than double what chemotherapy alone has historically produced.The data matter because they help explain the results Oncolytics has already reported in colorectal cancer, where the backdrop is equally encouraging. The company recently launched REO 033, a randomized Phase 2 trial testing pelareorep alongside bevacizumab and FOLFIRI in second-line RAS-mutated, microsatellite-stable metastatic colorectal cancer, a patient group with very few good treatment options today.The trial builds on earlier results from REO 022, where the same drug combination produced 27 months of overall survival, 11.2 months of progression-free survival, and a 33% objective response rate, against 16.6 months, 5.7 months, and roughly 10% for the standard of care. The FDA took notice, granting the regimen Fast Track Designation earlier this year. The second-line KRAS-mutant colorectal cancer market is estimated at $3 to $5 billion annually. REO 033 expects to open its first site next month, with preliminary data targeted for year-end 2026.Oncolytics is a clinical-stage biotechnology company that has spent years building a scientific case for pelareorep across multiple tumor types. Across anal cancer, pancreatic cancer, and now colorectal cancer, the drug is accumulating a consistent body of evidence as something that may make other gastrointestinal cancer treatments work better. That kind of backbone role, if confirmed in larger trials, could position Oncolytics as a meaningful partner in the broader immuno-oncology landscape, where combination strategies are increasingly where the field is heading.CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/In other industry developments:Gilead Sciences (NASDAQ: GILD) reported fourth quarter and full year 2025 financial results showing oncology revenues of $3.2 billion for the year, anchored by a 6% increase in Trodelvy sales to $1.4 billion on higher breast cancer demand, while Yescarta received a label update removing a limitation around Primary Central Nervous System Lymphoma, making it the only CAR-T therapy in relapsed or refractory large B-cell lymphoma to have that restriction lifted. The company also presented positive pivotal Phase 2 iMMagine-1 data for its Arcellx-partnered CAR T-cell therapy anitocabtagene autoleucel in 4L+ relapsed or refractory multiple myeloma at the 2025 American Society of Hematology meeting, with two additional cancer therapy launches anticipated in 2026."In 2026, our potential new launches include two cancer therapies and an additional HIV treatment option, and we look forward to building on the launches of Yeztugo and Livdelzi for liver disease," said Daniel O'Day, Chairman and CEO of Gilead Sciences.Gilead Sciences closed 2025 with $10.6 billion in cash and marketable debt securities and generated $10.0 billion in operating cash flow for the full year. For 2026, Gilead Sciences guides for total product sales of $29.6 billion to $30.0 billion and non-GAAP diluted EPS of $8.45 to $8.85, with anticipated oncology launches expected to contribute meaningfully to growth alongside continued HIV franchise momentum.enGene Holdings (NASDAQ: ENGN) reported Q1 2026 financial results reflecting continued advancement of its lead non-viral gene therapy candidate, detalimogene voraplasmid, toward a Biologics License Application submission targeted for the second half of 2026. The company's pivotal LEGEND cohort of 125 BCG-unresponsive NMIBC patients demonstrated a 63% complete response rate at any time and a 62% CR rate at 6 months, while enGene Holdings closed Q1 with $312.5 million in cash and marketable securities."As data from LEGEND's pivotal cohort in high-risk, BCG-unresponsive NMIBC continues to mature, we look forward to providing an update at a spring medical conference," said Ron Cooper, President and CEO of enGene Holdings. "With RMAT and CDRP designations for detalimogene, we are in active dialogue with the FDA to ensure regulatory and manufacturing readiness as we plan for a BLA submission in the second half of this year and potential launch in 2027."enGene Holdings expanded its Hercules Capital debt facility to $125 million in January 2026, providing additional non-dilutive capital ahead of its planned commercial launch. The company expects its current cash position to fund operations into the second half of 2028, and 12-month complete response data from the LEGEND pivotal cohort is expected in 2H 2026.TScan Therapeutics (NASDAQ: TCRX) reported Q4 and full year 2025 financial results while providing updates on its TCR-engineered T cell hematologic malignancies program, including the completion of enrollment in Cohort C of the Phase 1 ALLOHA trial and FDA clearance of INDs for two new CD45-targeting candidates, TSC-102-A01 and TSC-102-A03. Full year 2025 collaboration and license revenue reached $10.3 million versus $2.8 million in 2024, with cash and equivalents of $152.4 million expected to fund operations into 2H 2027."The regulatory and operational progress we have made over the last several months related to our heme program is exciting," said Gavin MacBeath, Ph.D., CEO of TScan Therapeutics. "We expect the momentum to continue into the second quarter when we plan to share the initial data from patients enrolled into Cohort C in the ALLOHA study as well as initiate TScan's first Phase 3 trial. The data we presented at ASH in December 2025 continue to support our decision to focus the Company's efforts on development of therapeutics for patients with heme malignancies. Additionally, the recent FDA clearance of INDs for TSC-102-A01 and TSC-102-A03 will allow us to bring our TCR-T therapies to twice as many patients who currently have limited options in the post-transplant setting."TScan Therapeutics discontinued its PLEXI-T solid tumor trial in November 2025 to concentrate resources on hematologic malignancies, and anticipates sharing preclinical proof-of-concept data from its autoimmunity program in 2H 2026. Updated Cohort C data and initiation of a Phase 1 study for TSC-102-A01 and TSC-102-A03 are both expected in the second half of 2026.Day One Biopharmaceuticals (NASDAQ: DAWN) announced a definitive acquisition agreement under which Servier will acquire all outstanding shares of Day One Biopharmaceuticals for $21.50 per share in cash, representing a total equity value of approximately $2.5 billion. The offer price represents a premium of approximately 68% over Day One Biopharmaceuticals' closing price on March 5, 2026, and approximately 86% over its one-month volume weighted average price, reflecting significant value recognition for the company's lead pediatric low-grade glioma program and broader oncology pipeline."Servier's successful track record in rare cancers and its commitment to advancing targeted therapies makes it the ideal home for our portfolio as part of Day One Biopharmaceuticals' mission to bring medicines to patients of all ages with life threatening diseases," said Jeremy Bender, Ph.D., CEO of Day One Biopharmaceuticals. "Joining Servier represents a unique opportunity to extend the reach of our science and our lead program in pediatric low-grade glioma."The transaction is subject to customary closing conditions, including shareholder tender and U.S. antitrust clearance, and is expected to close in Q2 2026. Day One Biopharmaceuticals' Board of Directors has unanimously recommended that shareholders tender their shares, and Servier expects to fund the acquisition through existing cash and investments.Article Source: usanewsgroup.comCONTACT:USA NEWS GROUP
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.pharmiweb.com/press-release/2026-02-19/oncology-market-value-to-more-than-double-reaching-usd-74817-billion-by-2035https://www.openpr.com/news/4395526/immuno-oncology-market-set-for-remarkable-expansion-ashttps://www.foley.com/insights/publications/2025/09/patent-cliff-ma-activity-for-companies-right-now/https://www.pharmexec.com/view/fda-s-new-accelerated-approval-draft-guidanceLogo - https://mma.prnewswire.com/media/2838876/5873016/USA_News_Group_Logo.jpg 





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Original: Combination Therapies Reshape Oncology: A $748B Market Shifts Standard of Care

Immunotherapy Delivers Across Tumor Types as Oncology Market Eyes $750 BillionMarch 3, 2026 9:00 AM
PR Newswire (US)

Issued on behalf of Oncolytics Biotech Inc.USANewsGroup.com News Commentary VANCOUVER, BC, March 3, 2026 /PRNewswire/ --The global oncology market is projected to nearly triple from $279.98 billion in 2026 to an estimated $748.17 billion by 2035, as immunotherapy continues to reshape the standard of care across solid tumors and hematologic cancers[1]. Cancer drug revenues alone are expected to reach $335.2 billion by 2033, driven by the rapid clinical adoption of targeted therapies, checkpoint inhibitors, and next-generation cell therapies[2]. Companies advancing breakthrough oncology pipelines across multiple indications include Oncolytics Biotech (NASDAQ: ONCY), Eli Lilly (NYSE: LLY), Gilead Sciences (NASDAQ: GILD), Arcellx (NASDAQ: ACLX), and Merck (NYSE: MRK).







The immuno-oncology segment is forecast to expand from $65.22 billion in 2025 to $170.19 billion by 2032 at a compound annual growth rate of 14.9%, driven by rising cancer prevalence and a wave of combination therapy approvals[3]. Immunotherapy drug development remains the fastest-growing area of oncology R&D, with checkpoint inhibitors, cancer vaccines, and cell therapies collectively attracting record levels of clinical investment[4].Oncolytics Biotech (NASDAQ: ONCY) has launched a study that could reshape how doctors treat one of the most stubborn forms of colorectal cancer. The company's randomized Phase 2 trial, REO 033, will evaluate pelareorep in combination with bevacizumab and FOLFIRI in second-line RAS-mutated (which includes KRAS), microsatellite-stable metastatic colorectal cancer, a patient population where current treatments offer limited benefit and new options are urgently needed."I am honored to lead this study as I have a long track record working with pelareorep and have witnessed its ability to improve patient outcomes in a meaningful way," said Dr. Sanjay Goel, Professor of Medicine at Rutgers Cancer Institute of New Jersey. "The colorectal cancer data we recorded in the REO 022 study continues to be compelling to this day, as evidenced by the Fast Track Designation, and I hope we can generate additional exciting data in this new trial to support registration."The confidence behind REO 033 stems from compelling data generated in a previous clinical study. Pelareorep combined with bevacizumab and FOLFIRI demonstrated 27 months of overall survival and 16.6 months of progression-free survival, compared to 11.2 and 5.7 months for the standard of care. Objective response rate was 33% versus approximately 10% for the standard of care, more than tripling the benchmark in a notoriously difficult-to-treat population. Notably, this treatment regimen was granted Fast Track Designation by the FDA earlier this year."The potential to improve clinical outcomes compared to the standard of care in the second-line setting would have the potential to benefit patients around the world who are affected by colorectal cancer," said Dr. Van Morris, Associate Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center. "An immunotherapy with the potential to improve outcomes would improve treatment options in colorectal cancer and would be highly welcomed, especially as we are seeing more and more patients being diagnosed with colorectal cancer."The global market for second-line treatment in KRAS-mutant, microsatellite-stable metastatic colorectal cancer runs between $3-5 billion annually. The study will randomize 60 patients to either the pelareorep combination or a control arm of bevacizumab and FOLFIRI, with objective response rate as the primary endpoint. Oncolytics expects to open the first study site later this month, with additional clinical sites added in quick succession, and preliminary data is expected by year-end 2026.CONTINUED… Read this and more news for Oncolytics Biotech at:
https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/In other industry developments:Eli Lilly (NYSE: LLY) has reported results showing substantial event-free survival benefit for Retevmo (selpercatinib) as an adjuvant therapy in early-stage RET fusion-positive lung cancer, expanding the role of targeted therapy in oncology. The LIBRETTO-432 trial enrolled 151 patients across a global, multicenter study, generating one of the largest datasets ever assembled for adjuvant targeted therapy in this setting."We have consistently observed that cancer medicines can deliver their greatest impact when administered early in the course of a patient's treatment journey," said Jacob Van Naarden, Executive Vice President and President of Lilly Oncology. "The LIBRETTO-432 results support this observation, demonstrating an effect size in line with the most striking data for targeted adjuvant therapy in lung cancer."Lilly's breast cancer drug Verzenio (abemaciclib) generated $5.3 billion in full-year 2025 revenue, an 8% increase year over year, reinforcing the company's position as a leader in targeted oncology therapeutics. The Retevmo adjuvant data further strengthens a pipeline spanning solid tumors, hematologic cancers, and novel modalities.Gilead Sciences (NASDAQ: GILD) has agreed to acquire Arcellx (NASDAQ: ACLX) in a $7.8 billion transaction to maximize the long-term potential of anito-cel, a next-generation CAR-T cell therapy for relapsed or refractory multiple myeloma. The FDA has accepted the anito-cel BLA for review, with a potential launch later this year that would add a second CAR-T product to Gilead's oncology portfolio alongside Yescarta."This agreement reflects our conviction in the potential of anito-cel and our intention to move with speed so we can make the most of that potential for patients with multiple myeloma," said Daniel O'Day, Chairman and CEO of Gilead Sciences. "Beyond the potential launch this year, anito-cel could become a foundational treatment for multiple myeloma over time, including earlier lines of therapy."The acquisition underscores the accelerating consolidation in cell therapy, where large-cap oncology companies are paying premium valuations for differentiated platforms with near-term regulatory catalysts. Gilead's combined cell therapy franchise, anchored by Yescarta and now anito-cel, positions the company as one of the largest players in the rapidly expanding CAR-T market.Merck (NYSE: MRK) has presented new data at the 2026 ASCO GU Cancers Symposium demonstrating that Keytruda in combination with Padcev significantly improved event-free survival, overall survival, and pathologic complete response in muscle-invasive bladder cancer. The KEYNOTE-B15 results represent the latest expansion of Keytruda's genitourinary oncology portfolio."We're excited to share new results from our portfolio and pipeline for more patients with certain types of bladder and kidney cancers," said Dr. Marjorie Green, Senior Vice President and Head of Oncology, Global Clinical Development at Merck Research Laboratories. "The results we're presenting at ASCO GU underscore our leadership across the genitourinary cancer landscape and our commitment to advance standards of care for these patients."Merck's Keytruda franchise generated over $31 billion in global sales in 2025, maintaining its position as the world's top-selling oncology drug. The company is advancing clinical trials across virtually every major solid tumor type, including ongoing studies in colorectal and gastrointestinal cancers where immunotherapy combinations are showing increasing promise.CONTACT:
USA NEWS GROUP
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.pharmiweb.com/press-release/2026-02-19/oncology-market-value-to-more-than-double-reaching-usd-74817-billion-by-2035https://www.prnewswire.com/news-releases/oncologycancer-drugs-market-to-reach-335-2-billion-by-2033-globally-at-7-2-cagr-allied-market-research-302683974.htmlhttps://www.openpr.com/news/4395526/immuno-oncology-market-set-for-remarkable-expansion-ashttps://www.globenewswire.com/news-release/2026/02/17/3239494/28124/en/Immunotherapy-Drugs-Market-Research-and-Forecast-Report-2020-2025-2025-2026-with-Analyst-Recommendations-Adoption-of-AI-in-Drug-Discovery-Combination-Therapies.htmlLogo - https://mma.prnewswire.com/media/2838876/5831976/USA_News_Group_Logo.jpg



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Original: Immunotherapy Delivers Across Tumor Types as Oncology Market Eyes $750 Billion

Gilead’s Single-Tablet Regimen of Bictegravir and Lenacapavir Maintained Virological Suppression in People With HIV Who Switched Antiretroviral TherapyFebruary 25, 2026 1:44 PM
Business Wire
– Novel Investigational Combination Pairs Bictegravir, a Global Guideline-Recommended Integrase Strand Transfer Inhibitor with a High Barrier to Resistance with Lenacapavir, a First-in-Class Capsid Inhibitor –


– Phase 3 ARTISTRY-1 and ARTISTRY-2 Results will Inform Regulatory Filings –


Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of new Phase 3 ARTISTRY-1 and ARTISTRY-2 trial data at CROI 2026 showing a treatment switch to an investigational, single-tablet combination regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) was effective in people living with HIV with virological suppression, including those switching from complex multi-tablet regimens or a global guideline-recommended single-tablet regimen. The novel combination of BIC/LEN was generally well tolerated, with no significant or new safety concerns identified.


“The ARTISTRY trials represent the latest example of Gilead’s commitment to advancing HIV treatment through continuous scientific innovation,” said Jared Baeten, M.D., Ph.D., Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences. “This once-daily single-tablet regimen combines the durability of bictegravir with lenacapavir, a first-in-class capsid inhibitor. The novel treatment combination is designed to sustain virologic suppression for those seeking new options. We look forward to working with regulatory authorities to potentially bring this combination forward to people with HIV.”


The results demonstrate the potential of BIC/LEN to broaden HIV treatment options for adults with virological suppression, offering comparable efficacy to BIKTARVY® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF), as well as to treatment with complex multi-tablet regimens.


The new data, from the ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) trials, assessed the safety and efficacy of the once-daily single tablet regimen of BIC/LEN and were presented during late-breaker sessions at the 33rd Conference on Retroviruses and Opportunistic Infections in Denver, Colorado. The findings build on the positive topline results announced in November and December 2025.


Late-breaking results from ARTISTRY-1


Results presented at CROI 2026 demonstrate that a single-tablet regimen combining BIC/LEN could offer an important new option with optimized dosing for people living with HIV with virologic suppression on a complex multi-tablet regimen. Week 48 results showed that the single-tablet regimen of BIC/LEN was noninferior to complex multi-tablet regimens in maintaining virologic suppression, with 0.8% of participants receiving BIC/LEN having HIV-1 RNA ≥ 50 copies/mL (as determined by the US FDA-defined snapshot algorithm) compared to 1.1% who remained on their complex antiretroviral regimen. CD4 cell count remained stable in both treatment groups, and no participant had emergent resistance. At Week 48, the switch to BIC/LEN from complex multi-tablet regimens was also associated with an improvement from baseline in fasting lipid parameters, with a median change in total cholesterol, -15 mg/dL, versus +2 mg/dL. Additionally, patient-reported treatment satisfaction on the HIVTSQs score increased by a mean of 7 points from baseline, with those treated with complex multi-tablet regimens reporting no change.


“Pre-existing viral resistance, intolerance, contraindications, or drug-drug interactions, may prevent many people living with HIV from benefiting from guideline-recommended single-tablet antiretroviral regimens. Complex treatment regimens can pose a significant burden on people’s lives as can be seen in the ARTISTRY-1 trial where participants were taking between 2 and 11 pills per day at baseline, with ~40% taking antiretroviral therapy more than once a day,” said Chloe Orkin, MBE, Clinical Professor of Infection and Inequities at Queen Mary University of London. “Finding new effective and convenient dosing with single-tablet regimens is key to optimizing treatment, ensuring that more people can benefit from recent advances in medical research like bictegravir and lenacapavir.”


BIC/LEN was generally well tolerated, with drug-related adverse events reported in 14.3% of participants who switched to BIC/LEN and 1.6% of participants who remained on complex multi-tablet regimens. A similar incidence of serious drug-related adverse events was reported in both treatment groups (0.3% BIC/LEN; 0% complex multi-tablet regimen), with discontinuations due to adverse events rare (1.6% and 0.5%, respectively).


On February 25, 2026, The Lancet published the primary outcome results of the ARTISTRY-1 trial. The manuscript is titled Switch to single-tablet bictegravir/lenacapavir from a complex HIV regimen: results from ARTISTRY-1, a randomised, open-label phase 3 clinical trial.


Late-breaking results from ARTISTRY-2


Results from the ARTISTRY-2 trial presented at CROI 2026 further demonstrate the potential of BIC/LEN to broaden current HIV treatment options, offering comparable efficacy to BIKTARVY, a global guideline-recommended single-tablet treatment regimen. Through Week 48, BIC/LEN was non-inferior to standard of care treatment with BIKTARVY in maintaining virologic suppression, with 1.3% of participants receiving BIC/LEN having HIV-1 RNA ≥ 50 copies/mL (as determined by the US FDA-defined snapshot algorithm) compared to 1.0% who remained on BIKTARVY. CD4 cell count remained stable, and two participants in each treatment group met the criteria for resistance analysis.


Resistance analysis showed no treatment-emergent resistance through Week 48 in three of the four participants (one BIC/LEN-treated and both BIKTARVY-treated participants). An isolated integrase substitution without phenotypic resistance was detected in one participant in the BIC/LEN treatment group at Week 36. No capsid mutations were detected. Switching to BIC/LEN was shown to have no significant impact on weight, with body-mass index remaining stable in both groups through 48 weeks of treatment.


BIC/LEN was generally well tolerated with similar rates of drug-related adverse events reported in the BIC/LEN and BIKTARVY treatment groups (10.4% and 12.0%, respectively). No serious drug-related adverse events were reported, and discontinuations due to adverse events were low (1.6%) in both treatment groups.


“The findings from ARTISTRY-2 support the potential of the bictegravir/lenacapavir regimen to expand the range of single-tablet antiretroviral treatments available to people living with HIV,” said Eric Meissner, MD, PhD, Associate Professor, Director of HIV and Hepatitis Patient Care and Research, Medical University of South Carolina. “With efficacy shown to be comparable to a guideline-recommended therapy, we look forward to the prospect of having another meaningful treatment option for adults with HIV who are virologically suppressed.”


Bictegravir and lenacapavir in combination are investigational and not approved anywhere globally. The safety and efficacy of this combination use has not been established.


There is currently no cure for HIV or AIDS.


About ARTISTRY-1


ARTISTRY-1 (NCT05502341) is a multicenter Phase 2/3 clinical trial comparing the investigational once-daily combination of bictegravir, a global guideline-recommended integrase strand transfer inhibitor, and lenacapavir, a first-in-class capsid inhibitor, versus current therapy in people with HIV who are virologically suppressed on complex regimens. In Phase 3, participants were randomized 2:1 to receive a fixed-dose combination of bictegravir 75 mg/lenacapavir 50 mg or continue their stable baseline complex regimen. The primary endpoint was the proportion of patients with HIV-1 RNA ≥50 copies/mL at Week 48 as determined by the US FDA-defined snapshot algorithm. Key secondary endpoints at week 48 included the proportion of participants with virologic suppression (HIV viral load

Oncology Market Set to Nearly Triple: Here Are Five Companies Leading the ChargeFebruary 24, 2026 10:58 AM
PR Newswire (Canada)

Issued on behalf of Oncolytics Biotech Inc.VANCOUVER, BC, Feb. 24, 2026 /CNW/ -- USA News Group News Commentary, The global oncology market is on track to nearly triple in value over the next decade, growing from $279.98 billion in 2026 to an estimated $748.17 billion by 2035[1]. Cancer drug revenues alone are projected to reach $335.2 billion by 2033, driven by a surge in targeted therapies and immunotherapy adoption[2]. Five companies advancing novel approaches in the oncology sector include Oncolytics Biotech (NASDAQ: ONCY), Exelixis (NASDAQ: EXEL), Eli Lilly (NYSE: LLY), Merck (NYSE: MRK), and Gilead Sciences (NASDAQ: GILD).







The immunotherapy drugs market is experiencing significant growth as rising cancer prevalence accelerates demand for targeted treatments and combination therapies[3]. The immuno-oncology segment specifically is forecast to expand from $65.22 billion in 2025 to $170.19 billion by 2032, representing a compound annual growth rate of 14.9%[4].Oncolytics Biotech Inc. (NASDAQ: ONCY) recently announced its decision to focus on registrational programs in anal and colorectal cancer, concluding enrollment in the GOBLET gastrointestinal study after generating sufficient clinical and translational data to chart a clear path toward FDA approval.The promising efficacy signal in GOBLET Cohort 4 has defined a clear registrational path for pelareorep in second-line and later squamous cell anal cancer, a setting where available therapies offer only limited benefit to patients. Oncolytics expects to meet with the FDA in mid-April to align on study design, and believes a clinical trial of well under 100 subjects will be sufficient to secure approval in this rare cancer indication.With sufficient cash on hand to execute near-term milestones, the company expects to avoid immediate material dilution, redirecting capital from the GOBLET cohorts toward its highest-conviction registration programs."GOBLET has done its job successfully. We now know where pelareorep can make the greatest impact for patients and where we can pursue approval most efficiently," said Jared Kelly, CEO of Oncolytics Biotech. "Our disciplined strategy is to run registrational or registration-enabling studies with ruthless efficiency that can create maximum shareholder value without unnecessary dilution."The registration push builds on pelareorep's recent Fast Track Designation from the FDA for second-line KRAS-mutant microsatellite-stable (MSS) metastatic colorectal cancer. Clinical data showed pelareorep combined with standard chemotherapy and Avastin® achieved a 33% response rate versus roughly 10% with chemotherapy and Avastin®, while median overall survival reached 27 months versus 11.2 months with standard treatment.KRAS-mutant MSS colorectal cancer represents one of the hardest-to-treat populations, with limited options after first-line treatment fails. The global market for second-line treatment in this patient group runs between $3 billion and $5 billion annually. The company plans to launch a controlled study with the first clinical site activating in March and interim data expected by year-end 2026.Pelareorep is also delivering strong results in anal cancer, where third-line patients achieved a 29% response rate with the median duration of response lasting around 17 months in a setting with no FDA-approved treatments. In second-line or later patients, the 30% response rate more than doubled the benchmark for the FDA-approved immunotherapy.The company continues strengthening its leadership, having recently appointed John McAdory as EVP of Strategy and Operations and Yujun Wu as Head of Biostatistics. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024.CONTINUED… Read this and more news for Oncolytics Biotech at:https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/In other industry developments:Exelixis (NASDAQ: EXEL) reported strong results for fiscal year 2025, with U.S. net product revenues from its cabozantinib franchise reaching $2.1 billion. The FDA accepted the company's New Drug Application for zanzalintinib in combination with atezolizumab for previously treated metastatic colorectal cancer."The team is highly motivated to build a second Exelixis oncology franchise with zanzalintinib and is working diligently to advance a first potential indication in metastatic colorectal cancer, following the recent acceptance of our New Drug Application by U.S. regulatory authorities," said Michael M. Morrissey, Ph.D., President and CEO of Exelixis.The company has a target FDA action date of December 2026 for zanzalintinib, which could establish a second major oncology franchise.Eli Lilly (NYSE: LLY) announced positive results from its Phase 3 LIBRETTO-432 trial, showing that Retevmo delivered a highly statistically significant improvement in event-free survival as adjuvant therapy in early-stage RET fusion-positive non-small cell lung cancer. The trial is the first randomized Phase 3 study to evaluate a selective RET kinase inhibitor in this population."We have consistently observed that cancer medicines can deliver their greatest impact when administered early in the course of a patient's treatment journey," said Jacob Van Naarden, executive vice president and president of Lilly Oncology.The company plans to present detailed results at an upcoming medical congress and discuss findings with global health authorities.Merck (NYSE: MRK) received FDA approval for KEYTRUDA and its subcutaneous formulation KEYTRUDA QLEX plus paclitaxel for adults with PD-L1-positive platinum-resistant ovarian cancer. KEYTRUDA is the first PD-1 inhibitor approved for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma."For many patients with ovarian cancer, the disease can become platinum-resistant, at which point recurrence is not just a setback, it's when options can become limited, and the reality patients face can change very quickly," said Dr. Bradley Monk, gynecologic oncologist at Florida Cancer Specialists and Research Institute.The KEYNOTE-B96 trial demonstrated a 28% reduction in the risk of disease progression or death and a 24% reduction in the risk of death compared to placebo.Gilead Sciences (NASDAQ: GILD) received an updated label for its Kite subsidiary's Yescarta CAR T-cell therapy, with the FDA removing previous limitations of use in relapsed or refractory primary central nervous system lymphoma. Yescarta is now the only CAR T-cell therapy approved for large B-cell lymphoma with this designation."This update to the axi-cel prescribing information provides clinicians with important evidence for patients who have historically had very limited treatment options," said Lakshmi Nayak, MD, Director of the Center for CNS Lymphoma at Dana-Farber Cancer Institute.Article Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/CONTACT:
USA NEWS GROUP
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.pharmiweb.com/press-release/2026-02-19/oncology-market-value-to-more-than-double-reaching-usd-74817-billion-by-2035https://www.prnewswire.com/news-releases/oncologycancer-drugs-market-to-reach-335-2-billion-by-2033-globally-at-7-2-cagr-allied-market-research-302683974.htmlhttps://www.globenewswire.com/news-release/2026/02/17/3239494/28124/en/Immunotherapy-Drugs-Market-Research-and-Forecast-Report-2020-2025-2025-2026-with-Analyst-Recommendations-Adoption-of-AI-in-Drug-Discovery-Combination-Therapies.htmlhttps://www.openpr.com/news/4395526/immuno-oncology-market-set-for-remarkable-expansion-asLogo - https://mma.prnewswire.com/media/2838876/5821139/USA_News_Group_Logo.jpg



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Original: Oncology Market Set to Nearly Triple: Here Are Five Companies Leading the Charge

Gilead Sciences to Present at Upcoming Investor ConferencesFebruary 23, 2026 4:05 PM
Business Wire
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its executives will be speaking at the following investor conferences:



TD Cowen Annual Health Care Conference on Tuesday, March 3 at 11:10 AM Eastern Time




Leerink Partners Global Healthcare Conference on Tuesday, March 10 at 11:20 AM Eastern Time




Barclays Annual Global Healthcare Conference on Wednesday, March 11 at 11:00 AM Eastern Time



The live webcasts can be accessed at the company’s investors page at investors.gilead.com. The replays will be available for at least 30 days following the presentation.


About Gilead Sciences


Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.


For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter ( @Georgia Bard-GILEAD-5 or 1-650-574-3000.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260223506818/en/
Jacquie Ross, CFA – Investors

investor_relations@gilead.com


Original: Gilead Sciences to Present at Upcoming Investor Conferences

Arcellx Shares Surge After Gilead Announces $7.8B Takeover DealFebruary 23, 2026 10:37 AM
IH Market News
Arcellx Inc. (NASDAQ:ACLX) shares soared 78.3% in premarket trading Monday after Gilead Sciences (NASDAQ:GILD) revealed plans to acquire the biotechnology company in a transaction valuing its equity at approximately $7.8 billion.Under the terms of the agreement, Arcellx shareholders will receive $115 per share in cash along with a contingent value right (CVR) worth up to $5 per share, tied to future commercial milestones.The acquisition expands upon the companies’ existing partnership focused on anitocabtagene autoleucel (anito-cel), an investigational BCMA-targeted CAR T-cell therapy being developed for patients with multiple myeloma. Through the deal, Gilead will obtain full ownership of anito-cel, removing existing profit-sharing arrangements, milestone obligations and royalty payments.The U.S. Food and Drug Administration has already accepted the Biologics License Application for anito-cel as a fourth-line treatment for relapsed or refractory multiple myeloma. The therapy currently carries a Prescription Drug User Fee Act (PDUFA) decision date of December 23, 2026. Regulatory submissions are supported by findings from a Phase 1 trial and the pivotal Phase 2 iMMagine1 study.“This agreement reflects our conviction in the potential of anito-cel and our intention to move with speed so we can make the most of that potential for patients with multiple myeloma,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences.The $115-per-share cash consideration represents a 68% premium to Arcellx’s 30-day volume-weighted average share price as of February 20, 2026. The CVR provides an additional $5 per share if cumulative global net sales of anito-cel reach at least $6.0 billion between launch and the end of 2029.Both companies’ boards have approved the transaction, which is expected to close in the second quarter of 2026, subject to regulatory approvals and customary closing conditions. Gilead currently holds roughly 11.5% of Arcellx’s outstanding shares.If anito-cel receives FDA approval, the acquisition is expected to contribute positively to Gilead’s earnings per share beginning in 2028 and beyond.Arcellx stock price

Original: Arcellx Shares Surge After Gilead Announces $7.8B Takeover Deal

Gilead Sciences to Acquire Arcellx to Maximize Long-term Potential of Anito-celFebruary 23, 2026 6:01 AM
Business Wire
– Builds on Successful 2022 Collaboration on Anito-cel, a Potentially Transformative Treatment for Patients with Multiple Myeloma –


– FDA Accepted Anito-cel BLA for the Treatment of Adult Patients with Relapsed/Refractory Multiple Myeloma –


– Provides Gilead with Full Control of Anito-cel, Accelerating Development and Commercialization while Eliminating Profit-Share, Milestones, and Royalties –


Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it has entered into a definitive agreement to acquire Arcellx (Nasdaq: ACLX) for $115 per share in cash at closing and one contingent value right of $5 per share, which represents an implied equity value of $7.8 billion payable at closing. Arcellx is a biotechnology company focused on delivering a new class of innovative immunotherapies for patients with cancer and other incurable diseases.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260223744889/en/
Kite, a Gilead company, and Arcellx have an existing collaboration to co-develop and co-commercialize Arcellx’s lead pipeline candidate, anitocabtagene autoleucel (anito-cel), an investigational BCMA-directed CAR T-cell therapy for patients with multiple myeloma. Despite advancements in treatment, many patients with multiple myeloma eventually relapse and require additional lines of therapy. As disease progresses, patients often experience diminishing responses, increasing toxicity and fewer viable options, especially those who are heavily pretreated or unable to tolerate existing therapies.


In clinical studies to date, anito-cel has demonstrated deep and durable responses with a predictable and manageable safety profile, addressing key challenges associated with current CAR T-cell therapies in multiple myeloma.


The BLA for anito-cel as a fourth-line treatment for patients with relapsed or refractory multiple myeloma is supported by results from the Phase 1 study (NCT04155749) and the pivotal Phase 2 iMMagine1 study (NCT05396885) and has been accepted by the U.S. Food and Drug Administration with an anticipated Prescription Drug User Fee Act (PDUFA) action date of December 23, 2026.


“This agreement reflects our conviction in the potential of anito-cel and our intention to move with speed so we can make the most of that potential for patients with multiple myeloma,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. "Beyond the potential launch this year, anito-cel could become a foundational treatment for multiple myeloma over time, including earlier lines of therapy. In addition, the anito-cel D-domain BCMA binder could be important to our work in in vivo cell therapy, further strengthening our potential in oncology and inflammation.”


In addition to anito-cel, Arcellx’s D-Domain CAR technology platform has generated proprietary, target-binding domains with improved specificity and enhanced binding affinity that could potentially be used for next-generation CAR T-cell and bispecific therapies. There is potential to leverage the D-domain BCMA binder in vivo cell therapy efforts.


“The story of Arcellx is one of innovation, passion, resilience and teamwork. I could not be prouder of our team, our contribution to the myeloma field, and the impact anito-cel and our D-Domain platform are poised to have for patients and clinicians,” said Rami Elghandour, Chairman and Chief Executive Officer, Arcellx. “We are fortunate to have found a world-class partner in Gilead, which has the expertise to carry forward Arcellx’s legacy. Kite is well-positioned to maximize access to anito-cel, benefiting more patients, and the company’s commitment to be the leader in cell therapy is one I admire. I’m grateful to our Board of Directors for this opportunity, our shareholders who supported our journey, our partners who believed in us, the patients and physicians who participated in our studies, and most of all, our team members who did the impossible and left an indelible mark on the future of medicine.”


Terms of the Transaction


The transaction was approved by both the Gilead and Arcellx Boards of Directors and is anticipated to close during the second quarter of 2026, subject to the satisfaction or waiver of customary closing conditions, including the tender of a number of shares of Arcellx common stock that, together with shares already owned by Gilead, equals at least a majority of the then-outstanding Arcellx shares, the receipt of regulatory approvals and other customary offer conditions. Gilead currently owns approximately 11.5 percent of Arcellx’s outstanding common stock.


Under the terms of the merger agreement entered into in connection with the transaction, a wholly-owned subsidiary of Gilead will commence a tender offer to acquire all of the outstanding shares of Arcellx’s common stock that Gilead does not already own for an offer price of (1) $115 per share in cash, which represents a 68 percent premium to Arcellx’s 30-day volume-weighted average share price as of February 20, 2026, plus (2) one non-transferable contingent value right (CVR) that entitles the holder to receive an additional $5 per CVR upon the achievement of cumulative global net sales of anito-cel of at least $6.0 billion from launch through year-end 2029. If the tender offer is successfully completed, Gilead will acquire all remaining shares of Arcellx not tendered in the offer through a second step merger for the same consideration as is paid in the tender offer.


Upon FDA approval of anito-cel, the proposed transaction is expected to be accretive to earnings per share in 2028 and thereafter.


BofA Securities, Inc. and Morgan Stanley & Co. LLC are acting as financial advisors to Gilead. Ropes & Gray LLP is serving as legal counsel to Gilead. Centerview Partners LLC is acting as exclusive financial advisor to Arcellx. Wilson Sonsini Goodrich & Rosati, P.C. is serving as legal counsel to Arcellx.


About Arcellx


Arcellx, Inc. is a clinical-stage biotechnology company focused on delivering a new class of innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine, and its mission is to advance humanity by developing novel therapies that are safer, more effective, and more broadly accessible.


About Gilead Sciences


Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.


Forward-Looking Statements


This communication contains forward-looking statements related to Gilead, Arcellx and the acquisition of Arcellx by Gilead that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of Gilead and Arcellx and members of their respective senior management teams. In some cases, forward-looking statements can be identified by the use of words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “seek,” “may,” “plan,” “project,” “should,” “target,” “will,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, without limitation, statements regarding the transaction and related matters, prospective performance and opportunities, post-closing operations and the outlook for the companies’ businesses, including, without limitation, the timing of the expected commercial launch of anito-cel and Gilead’s ability to streamline preparation and accelerate adoption and access to anito-cel if the transaction is consummated; the potential for anito-cel to become a foundational treatment, including for earlier lines of therapy; regulatory applications and related timelines, including the PDUFA date for anito-cel’s BLA; the potential of Arcellx’s cell therapy platform; filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability satisfy the various closing conditions and complete the transaction; the expectation that the transaction will be accretive to Gilead following FDA approval of anito-cel in the future; and any assumptions underlying any of the foregoing. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Arcellx’s stockholders will tender their stock in the offer; the possibility that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of the transaction on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; the risk that, if the transaction is consummated, the businesses will not be integrated successfully and that other anticipated benefits from the transaction will not be realized; any negative effects on the existing collaboration between Arcellx and Gilead that may result from the announcement of a transaction, or the failure to complete the transaction; the risk that the milestone associated with the CVR may not be achieved and that holders of CVRs may not receive payments in respect thereof; the impact of competitive products and pricing; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; transaction costs; actual or contingent liabilities; and other risks and uncertainties detailed from time to time in the companies’ periodic reports filed with the U.S. Securities and Exchange Commission (the “SEC”), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, as well as the Schedule 14D-9 to be filed by Arcellx and the Schedule TO and related tender offer documents to be filed by Gilead and Ravens Sub, Inc., a wholly owned subsidiary of Gilead. All forward-looking statements are based on information currently available to Gilead, and Gilead assume no obligation and disclaim any intent to update any such forward-looking statements.


Additional Information and Where to Find It


The tender offer described in this document has not yet commenced. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities of Arcellx, nor is it a substitute for any tender offer materials that Gilead, Ravens Sub, Inc. or Arcellx will file with the SEC. A solicitation and an offer to buy securities of Arcellx will be made only pursuant to an offer to purchase and related materials that Gilead intends to file with the SEC. At the time the tender offer is commenced, Gilead will file a Tender Offer Statement on Schedule TO with the SEC, and Arcellx will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. ARCELLX’S STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. The Offer to Purchase, the related letter of transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement on Schedule 14D-9, will be sent to all stockholders of Arcellx at no expense to them. The Tender Offer Statement on Schedule TO, the Solicitation/Recommendation Statement on Schedule 14D-9 and other related documents will be made available for free at the SEC’s web site at www.sec.gov. Additional copies may be obtained for free by contacting Gilead or Arcellx. Free copies of these materials and certain other offering documents will be made available by Gilead by mail to Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, attention: Investor Relations, by phone at 1-800-GILEAD-5 or 1-650-574-3000, or by directing requests for such materials to the information agent for the offer, which will be named in the Tender Offer Statement on Schedule TO. Investors and security holders of Arcellx may also obtain, free of charge, the Solicitation/Recommendation Statement on Schedule 14D-9 and other related documents that the Company has filed with or furnished to the SEC under the “Financials” section of Arcellx’s website at https://ir.arcellx.com/financials/sec-filings/default.aspx.


In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Gilead and Arcellx file annual, quarterly and current reports, proxy statements and other information with the SEC. Gilead’s and Arcellx’s filings with the SEC are also available for free to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.


Gilead, Kite, and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. The Arcellx name and logo are trademarks of Arcellx.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260223744889/en/
Gilead

Ashleigh Koss, Media

public_affairs@gilead.com

Jacquie Ross, Investors

investor_relations@gilead.com


Arcellx

Kristalle Cooks, Media

pr@Arcellx.com

Myesha Lacy, Investors

ir@Arcellx.com


Original: Gilead Sciences to Acquire Arcellx to Maximize Long-term Potential of Anito-cel

Gilead Sciences to Acquire Arcellx to Maximize Long-Term Potential of Anito-celFebruary 23, 2026 6:01 AM
Business Wire
– Builds on Successful 2022 Collaboration on Anito-cel, a Potentially Transformative Treatment for Patients with Multiple Myeloma –


– FDA Accepted Anito-cel BLA for the Treatment of Adult Patients with Relapsed/Refractory Multiple Myeloma –


– Provides Gilead with Full Control of Anito-cel, Accelerating Development and Commercialization while Eliminating Profit-Share, Milestones, and Royalties –


Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it has entered into a definitive agreement to acquire Arcellx (Nasdaq: ACLX) for $115 per share in cash at closing and one contingent value right of $5 per share, which represents an implied equity value of $7.8 billion payable at closing. Arcellx is a biotechnology company focused on delivering a new class of innovative immunotherapies for patients with cancer and other incurable diseases.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260222105602/en/
Kite, a Gilead company, and Arcellx have an existing collaboration to co-develop and co-commercialize Arcellx’s lead pipeline candidate, anitocabtagene autoleucel (anito-cel), an investigational BCMA-directed CAR T-cell therapy for patients with multiple myeloma. Despite advancements in treatment, many patients with multiple myeloma eventually relapse and require additional lines of therapy. As disease progresses, patients often experience diminishing responses, increasing toxicity and fewer viable options, especially those who are heavily pretreated or unable to tolerate existing therapies.


In clinical studies to date, anito-cel has demonstrated deep and durable responses with a predictable and manageable safety profile, addressing key challenges associated with current CAR T-cell therapies in multiple myeloma.


The BLA for anito-cel as a fourth-line treatment for patients with relapsed or refractory multiple myeloma is supported by results from the Phase 1 study (NCT04155749) and the pivotal Phase 2 iMMagine1 study (NCT05396885) and has been accepted by the U.S. Food and Drug Administration with an anticipated Prescription Drug User Fee Act (PDUFA) action date of December 23, 2026.


“This agreement reflects our conviction in the potential of anito-cel and our intention to move with speed so we can make the most of that potential for patients with multiple myeloma,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. "Beyond the potential launch this year, anito-cel could become a foundational treatment for multiple myeloma over time, including earlier lines of therapy. In addition, the anito-cel D-domain BCMA binder could be important to our work in in vivo cell therapy, further strengthening our potential in oncology and inflammation.”


In addition to anito-cel, Arcellx’s D-Domain CAR technology platform has generated proprietary, target-binding domains with improved specificity and enhanced binding affinity that could potentially be used for next-generation CAR T-cell and bispecific therapies. There is potential to leverage the D-domain BCMA binder in vivo cell therapy efforts.


“The story of Arcellx is one of innovation, passion, resilience and teamwork. I could not be prouder of our team, our contribution to the myeloma field, and the impact anito-cel and our D-Domain platform are poised to have for patients and clinicians,” said Rami Elghandour, Chairman and Chief Executive Officer, Arcellx. “We are fortunate to have found a world-class partner in Gilead, which has the expertise to carry forward Arcellx’s legacy. Kite is well-positioned to maximize access to anito-cel, benefiting more patients, and the company’s commitment to be the leader in cell therapy is one I admire. I’m grateful to our Board of Directors for this opportunity, our shareholders who supported our journey, our partners who believed in us, the patients and physicians who participated in our studies, and most of all, our team members who did the impossible and left an indelible mark on the future of medicine.”


Terms of the Transaction


The transaction was approved by both the Gilead and Arcellx Boards of Directors and is anticipated to close during the second quarter of 2026, subject to the satisfaction or waiver of customary closing conditions, including the tender of a number of shares of Arcellx common stock that, together with shares already owned by Gilead, equals at least a majority of the then-outstanding Arcellx shares, the receipt of regulatory approvals and other customary offer conditions. Gilead currently owns approximately 11.5 percent of Arcellx’s outstanding common stock.


Under the terms of the merger agreement entered into in connection with the transaction, a wholly-owned subsidiary of Gilead will commence a tender offer to acquire all of the outstanding shares of Arcellx’s common stock that Gilead does not already own for an offer price of (1) $115 per share in cash, which represents a 68 percent premium to Arcellx’s 30-day volume-weighted average share price as of February 20, 2026, plus (2) one non-transferable contingent value right (CVR) that entitles the holder to receive an additional $5 per CVR upon the achievement of cumulative global net sales of anito-cel of at least $6.0 billion from launch through year-end 2029. If the tender offer is successfully completed, Gilead will acquire all remaining shares of Arcellx not tendered in the offer through a second step merger for the same consideration as is paid in the tender offer.


Upon FDA approval of anito-cel, the proposed transaction is expected to be accretive to earnings per share in 2028 and thereafter.


BofA Securities, Inc. and Morgan Stanley & Co. LLC are acting as financial advisors to Gilead. Ropes & Gray LLP is serving as legal counsel to Gilead. Centerview Partners LLC is acting as exclusive financial advisor to Arcellx. Wilson Sonsini Goodrich & Rosati, P.C. is serving as legal counsel to Arcellx.


About Arcellx


Arcellx, Inc. is a clinical-stage biotechnology company focused on delivering a new class of innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine, and its mission is to advance humanity by developing novel therapies that are safer, more effective, and more broadly accessible.


About Gilead Sciences


Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.


Forward-Looking Statements


This communication contains forward-looking statements related to Gilead, Arcellx and the acquisition of Arcellx by Gilead that are subject to risks, uncertainties, and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of Gilead and Arcellx and members of their respective senior management teams. In some cases, forward-looking statements can be identified by the use of words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “seek,” “may,” “plan,” “project,” “should,” “target,” “will,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, without limitation, statements regarding the transaction and related matters, prospective performance and opportunities, post-closing operations and the outlook for the companies’ businesses, including, without limitation, the timing of the expected commercial launch of anito-cel and Gilead’s ability to streamline preparation and accelerate adoption and access to anico-cel if the transaction is consummated; the potential for anito-cel to become a foundational treatment, including for earlier lines of therapy; regulatory applications and related timelines, including the PDUFA date for anito-cel’s BLA; the potential of Arcellx’s cell therapy platform; filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability satisfy the various closing conditions and complete the transaction; the expectation that the transaction will be accretive to Gilead following FDA approval of anito-cel in the future; and any assumptions underlying any of the foregoing. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Arcellx’s stockholders will tender their stock in the offer; the possibility that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of the transaction on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; the risk that, if the transaction is consummated, the businesses will not be integrated successfully and that other anticipated benefits from the transaction will not be realized; any negative effects on the existing collaboration between Arcellx and Gilead that may result from the announcement of a transaction, or the failure to complete the transaction; the risk that the milestone associated with the CVR may not be achieved and that holders of CVRs may not receive payments in respect thereof; the impact of competitive products and pricing; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; transaction costs; actual or contingent liabilities; and other risks and uncertainties detailed from time to time in the companies’ periodic reports filed with the U.S. Securities and Exchange Commission (the “SEC”), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, as well as the Schedule 14D-9 to be filed by Arcellx and the Schedule TO and related tender offer documents to be filed by Gilead and Ravens Sub, Inc., a wholly owned subsidiary of Gilead. All forward-looking statements are based on information currently available to Gilead, and Gilead assume no obligation and disclaim any intent to update any such forward-looking statements.


Additional Information and Where to Find It


The tender offer described in this document has not yet commenced. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities of Arcellx, nor is it a substitute for any tender offer materials that Gilead, Ravens Sub, Inc. or Arcellx will file with the SEC. A solicitation and an offer to buy securities of Arcellx will be made only pursuant to an offer to purchase and related materials that Gilead intends to file with the SEC. At the time the tender offer is commenced, Gilead will file a Tender Offer Statement on Schedule TO with the SEC, and Arcellx will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. ARCELLX’S STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. The Offer to Purchase, the related letter of transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement on Schedule 14D-9, will be sent to all stockholders of Arcellx at no expense to them. The Tender Offer Statement on Schedule TO, the Solicitation/Recommendation Statement on Schedule 14D-9 and other related documents will be made available for free at the SEC’s web site at www.sec.gov. Additional copies may be obtained for free by contacting Gilead or Arcellx. Free copies of these materials and certain other offering documents will be made available by Gilead by mail to Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, attention: Investor Relations, by phone at 1-800-GILEAD-5 or 1-650-574-3000, or by directing requests for such materials to the information agent for the offer, which will be named in the Tender Offer Statement on Schedule TO. Investors and security holders of Arcellx may also obtain, free of charge, the Solicitation/Recommendation Statement on Schedule 14D-9 and other related documents that the Company has filed with or furnished to the SEC under the “Financials” section of Arcellx’s website at https://ir.arcellx.com/financials/sec-filings/default.aspx.


In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Gilead and Arcellx file annual, quarterly and current reports, proxy statements and other information with the SEC. Gilead’s and Arcellx’s filings with the SEC are also available for free to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.


Gilead, Kite, and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. The Arcellx name and logo are trademarks of Arcellx.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260222105602/en/
Gilead


Ashleigh Koss, Media

public_affairs@gilead.com


Jacquie Ross, Investors

investor_relations@gilead.com


Arcellx

Kristalle Cooks, Media

pr@Arcellx.com


Myesha Lacy, Investors

ir@Arcellx.com


Original: Gilead Sciences to Acquire Arcellx to Maximize Long-Term Potential of Anito-cel

Gilead tops Q4 estimates, but cautious 2026 guidance weighs on sharesFebruary 11, 2026 6:43 AM
IH Market News
Shares of Gilead Sciences (NASDAQ:GILD) fell more than 3% in premarket trading after the drugmaker issued a conservative full-year outlook, overshadowing better-than-expected fourth-quarter results.The company also announced a 3.8% increase to its quarterly dividend, raising the payout to $0.82 per share starting in the first quarter of 2026.For the fourth quarter, the biotech group reported adjusted earnings of $1.86 per share, beating consensus forecasts by $0.01.Revenue came in at $7.93 billion, ahead of analyst expectations of $7.68 billion, supported by ongoing strength in its HIV portfolio and contributions from recently launched treatments.Management described 2025 as a strong year overall, citing the U.S. debut of Yeztugo — a twice-yearly HIV prevention therapy — along with continued expansion of flagship HIV drugs Biktarvy and Descovy.Chief Executive Officer Daniel O’Day said Gilead enters 2026 with several potential product launches on the horizon, including two oncology treatments and another HIV therapy, as well as the continued rollout of Livdelzi for liver disease.Looking ahead, Gilead projected fiscal 2026 earnings in the range of $8.45 to $8.85 per share. The midpoint falls below Wall Street’s consensus estimate of $8.76.The company expects total product sales of $29.6 billion to $30 billion in fiscal 2026. While the upper end of that range is broadly aligned with analyst forecasts, the overall guidance leans toward the lower end of the Street’s $30 billion expectation.Gilead anticipates roughly $800 million in Yeztugo sales next year, largely in line with market estimates, and forecast HIV franchise growth of 6% year over year.The increased dividend will be paid on March 30, 2026, to shareholders on record as of March 13. The boost reflects management’s confidence in the company’s cash generation and capital return strategy, though future dividend payments remain subject to board approval.Gilead Sciences stock price

Original: Gilead tops Q4 estimates, but cautious 2026 guidance weighs on shares

Tech Bounce Holds Attention as Earnings Roll In; U.S. Retail Sales Awaited: Dow Jones, S&P, Nasdaq, Wall Street FuturesFebruary 10, 2026 5:39 AM
IH Market News
Futures tied to the main U.S. equity benchmarks were little changed on Tuesday as investors weighed a recent rebound in technology shares against a packed earnings calendar and key U.S. economic data due later this week. Results are scheduled from a range of blue chips, including CVS Health (NYSE:CVS) and Coca-Cola (NYSE:KO). Elsewhere, Japan’s Nikkei notched another record, while gold prices eased.



Futures steady after tech-led rebound



U.S. stock futures hovered near flat, signalling a tentative start to the session after Monday’s tech-driven advance.By 03:04 ET, Dow and S&P 500 futures were largely unchanged, while Nasdaq 100 futures slipped 18 points, or 0.1%.Wall Street’s major averages extended gains at the start of the week, building on momentum from late last week as technology stocks linked to the artificial intelligence buildout—particularly data centres—led the charge.Sentiment was further supported by a CNBC report citing comments from OpenAI chief executive Sam Altman, who said in an internal memo that ChatGPT had returned to growth. The development lifted expectations around one of the most influential hubs in the AI ecosystem. Analysts at Vital Knowledge noted that optimism around OpenAI helped prompt DA Davidson to upgrade its outlook for Oracle (NYSE:ORCL), which holds a $300bn data-centre contract with the ChatGPT developer.By the close, the Nasdaq Composite had climbed 0.9%, sitting just shy of a fresh record, while the S&P 500 also ended within striking distance of all-time highs.



Earnings rush continues



Another busy day of results is set to shape trading, as investors look for clues on corporate performance early in 2026.Ahead of the opening bell, reports are due from Marriott International (NASDAQ:MAR), Spotify (NYSE:SPOT), CVS Health and Coca-Cola. After the close, Gilead Sciences (NASDAQ:GILD) will publish its numbers.In after-hours moves, shares of Onsemi (NASDAQ:ON) fell after the chipmaker posted weaker-than-expected fourth-quarter revenue, citing a prolonged inventory overhang. Customers are still working through chip stockpiles accumulated during earlier supply-chain disruptions.Onsemi also flagged headwinds for its silicon carbide business from sluggish electric vehicle demand and intensifying competition from China. Its midpoint forecast for current-quarter sales came in below Wall Street expectations.



U.S. retail sales in focus



On the macro front, markets are bracing for December U.S. retail sales data.Household spending is the backbone of the U.S. economy, accounting for more than two-thirds of output and driving much of the 4.4% annualised GDP growth recorded in the third quarter.However, core retail sales—which exclude autos, gasoline, building materials and food services and are closely tied to the consumer component of GDP—are expected to rise 0.3% in the final month of 2025, easing from 0.5% in November.Some analysts point to a cooling labour market as a potential drag, although Federal Reserve officials in January characterised employment conditions as “stabilizing.” Analysts at ING said the data should still show “reasonably healthy” growth and reinforce the view that “the U.S. consumer is alive and well.”



Nikkei hits new high on “Takaichi trade”



Asian markets extended gains on Tuesday, led by Japan, where equities surged to fresh records on enthusiasm for the so-called “Takaichi trade” following Prime Minister Sanae Takaichi’s weekend election victory.Investors have welcomed expectations that Takaichi’s agenda will favour growth, profitability and domestic investment. Her decisive win has strengthened hopes for pro-business reforms, fiscal support and policies aimed at lifting capital investment, innovation and strategic industries.



Gold pulls back



Gold prices retreated on Tuesday, giving back part of Monday’s advance as markets remained cautious ahead of several important U.S. data releases.Silver and platinum also moved lower, despite limited support from an overnight dip in the dollar, which later stabilised during Asian trading.Precious metals have seen sharp swings over the past week, with profit-taking and stretched positioning pushing prices off record highs. Uncertainty around U.S. monetary policy—amid speculation over a potential change in Federal Reserve leadership—has added to volatility.Safe-haven demand for gold was also tempered by mixed signals in U.S.-Iran relations. While both sides reported progress in weekend talks over Iran’s nuclear programme, Washington nevertheless issued a warning on Monday to U.S.-flagged vessels transiting the Strait of Hormuz.CVS Health stock priceCoca-Cola stock priceOracle stock priceMarriott International stock priceSpotify stock priceGilead Sciences stock priceON Semiconductor stock price

Original: Tech Bounce Holds Attention as Earnings Roll In; U.S. Retail Sales Awaited: Dow Jones, S&P, Nasdaq, Wall Street Futures

Gilead Sciences to Release Fourth Quarter & Full Year 2025 Financial Results on Tuesday, February 10, 2026January 27, 2026 9:05 PM
Business Wire
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its fourth quarter and full year 2025 financial results and guidance will be released on Tuesday, February 10, 2026 after the market closes. At 4:30 p.m. Eastern Time that day, Gilead’s management will host a webcast to discuss the company’s fourth quarter and full year 2025 financial results and provide a business update.


A live webcast will be available in the Investors section of www.gilead.com and will be archived there for one year.


About Gilead Sciences


Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.


For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter ( @Georgia Bard-GILEAD-5 or 1-650-574-3000.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260127158594/en/
Jacquie Ross, CFA – Investors

investor_relations@gilead.com


Original: Gilead Sciences to Release Fourth Quarter & Full Year 2025 Financial Results on Tuesday, February 10, 2026

Yes. GILD should be over $180, maybe $250 5 years ago. Institutions are not buying as hard as they should have.

I bought GILD shares in my IRA on 6/26/1996 at a split-adjusted price of $0.76/share, now have a 16102% LTCG on those shares. And you say Wall Street hates GILD? I use the GILD quarterly dividend to buy shares of other companies. Retired in 2016 at age 79.

I got no idea. All my inside people have long gone that Company. But wow!

Maybe urs destined to kiss $200 like other big pharmas.
I've always been amazed it stays as low as it does.
Wall Streets always hated GILD.

Why the > $5/share jump for GILD today?

Just took out $180k
$30k cash for taxes. $150k day makes my quota for next year.

Yeztugo exclusion from listing/coverage by CVS/Caremark formulary seems to have far greater effect on GILD share price; reported by IBD, TipRanks, Reuters and many others in past 8 days. No discussion here?

Now https://www.fiercebiotech.com/biotech/gileads-kite-sails-vivo-car-t-space-350m-interius-buyout

In­terius' ther­a­py us­es a CD7-targeted lentivi­ral vec­tor and gen­er­ates both CAR-T and CAR-NK cells in the body, though the CAR-T cells far out­num­ber the CAR-NK cells https://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(25)00487-3

The com­pa­ny was the first to dose a pa­tient without LD chemo as part of a PhI tri­al in Aus­tralia. In­terius, which is study­ing INT2104 (anti-CD20) in R/R B-cell malignancies, has al­so re­ceived ap­proval to start test­ing its ther­a­py in Spain and Ger­many. Be­fore the deal, the com­pa­ny was ex­pect­ed to re­port its first da­ta lat­er this year (likely ASH). In­terius has dosed six pa­tients to date, and the com­pa­ny shared the da­ta it has so far as part of the deal­ mak­ing process.

Yescarta and Tecartus looked to have peaked, so anito-cel vs Carvykti will be the major battle in the upcoming years. Abecma will continue to lose market share.

Breyanzi will overtake Yescarta in second place, but KITE-197, KITE-363, or KITE-753 may change this given enough time.

Pure wisdom.
The drug is great for humanity, but will it sell?

Will it be considered a drug of convenience and get snubbed on the reimbursement side?

Will State pharmacy directors like Atlanta, LA, NY, Chicago, Miami SFO fight for this?

$115
Was a sweet show. Now can it ever break above and stay?

I just kissed $500k briefly. Give me a woody,
Now can Trump do something with LT capital gains in Sept? If I see another 33% from $115? I'm out. Pay my taxes and tell DC to fu'k off. Come on $150+ wallstreet always hated GILD.
I'm waiting on that. Maybe $115 will be a pipe dream on the BID side by then.

I want out if Trump kills the tax rate. Get mine before the masses cash in.
He made waves about ending taxes on home sales, I doubt stock market gains. We are the evil rich ones that need to pay our fair share.

I want another beach condo rental. I'm done with pharma. She's been a life changer for me,
Time to roll.

Big heart out to Gilead,

They are moving beyond quadruple edited to build a sextuple-edited CAR-T therapy for glioblastoma.

https://www.cnbc.com/2025/06/18/fda-approves-gilead-hiv-prevention-injection-lenacapavir.html

This should be great news, but from a financial, shareholder perspective, there are concerns about cost and availability, with U.S. government programs cutting funding for HIV prevention programs.

I've heard that an MD Anderson team is developing an off-the-shelf IL-21 armoured CAR-NK cell therapy that will target EGFR and IL13Ra2 https://www.cell.com/cancer-cell/abstract/S1535-6108(24)00272-1

They are also testing another off-the-shelf NK cell therapy with containing deleted of TGFBR2 and NR3C1 in recurrent glioblastoma. This makes the NKs resistant to tumour- and corticosteroid-induced immunosuppression, respectively. Going forward, they plan to test these NKs with Delta-24-RGD https://ascopubs.org/doi/10.1200/JCO.2017.75.8219

When combined with NKs, they found that treatment with Delta-24-RGD altered the immunosuppressive tumour microenvironment and increased the recruitment, antitumour activity, survival, and memory of endogenous NKs as well.

It will be interesting to see GILD's KITE-753 clinical data. The only difference between it (and KITE-363) is a reduced production time.

However, based on preclinical data, KITE-753 exhibited higher expression of both CARs and increased proportion of CCR7+/CD45RA+ T-cells* compared to the KITE-363 benchmark.

Also, KITE-753 exhibited enhanced cytokine production, enhanced proliferation, increased peripheral peak expansion, and superior antitumour efficacy compared to the KITE-363 benchmark.

* CCR7+/CD45RA+CD4+ of ~60% vs ~5%, and CCR7+/CD45RA+CD8+ of ~80% vs ~15%. High circulating CCR7+ populations positively correlate with antitumour response https://www.nature.com/articles/s41591-020-1061-7

Others https://www.oncologypipeline.com/apexonco/lyell-takes-jj-and-gilead

An update https://www.oncologypipeline.com/apexonco/eha-2025-arcellx-still-hopes-safety-will-trump-efficacy

The UPenn team have been developing this https://jitc.bmj.com/content/11/Suppl_1/A323

One company is developing an off-the-shelf version https://www.kiragenbio.com/our-science

ASCO: Kite's CAR-T passes lymphoma safety trial with flying colors https://www.fiercebiotech.com/biotech/asco-kites-car-t-passes-lymphoma-safety-trial-flying-colors

Dual-target CAR T cell therapy slows growth of aggressive brain cancer https://medicalxpress.com/news/2025-05-dual-car-cell-therapy-growth.html