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The Quest to Repair What Multiple Sclerosis Takes AwayJune 24, 2026 9:00 AM
InvestorsHub NewsWireThe Quest to Repair What Multiple Sclerosis Takes AwayBioMedWire Editorial Coverage: Multiple sclerosis ("MS") gradually strips people of command over their own bodies, advancing steadily with no available cure. More than 2.9 million people across the globe are currently living with the disease. But even with generations of scientific study and research, every approved treatment still falls short of one essential objective: bringing the disease to a complete stop. Existing therapies can slow its advance, but none can halt it outright. That shortfall translates into a future of mounting disability for millions of MS sufferers. Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (Profile) is determined working to change that outcome. The company is developing Lucid-MS, a patented, first-in-class drug candidate that approaches the disease from an entirely different angle by directly targeting the myelin sheath that MS destroys; the potential treatment is now preparing to move into phase 2 clinical trials. Quantum BioPharma stands among a group of companies pursuing therapies for neurological, autoimmune and immune-mediated conditions, a group that also includes Novartis AG (NYSE: NVS), Merck & Co. Inc. (NYSE: MRK), TG Therapeutics Inc. (NASDAQ: TGTX) and Bristol Myers Squibb Company (NYSE: BMY).Multiple sclerosis is especially destructive because of its tendency to worsen progressively.Instead of working through the immune system, Quantum BioPharma's Lucid-MS acts directly on the myelin sheath.The scientific case behind Lucid-MS rests on years of disciplined research.Quantum BioPharma has finished dosing in both 180-day, repeated-dose oral toxicity and toxicokinetic studies for Lucid-21-302.Click here to view the custom infographic of the Quantum BioPharma editorial.A Disease That Erodes Movement, IndependenceMultiple sclerosis is a long-term inflammatory condition affecting the central nervous system. In MS, the immune system mistakenly attacks the brain and spinal cord, damaging myelin, the protective coating around nerve fibers that allows electrical impulses to travel efficiently. As myelin breaks down, these signals slow, falter or fail altogether, resulting in a mix of symptoms that can include tingling, vision disturbances, mobility difficulties, cognitive decline and, over time, a progressive erosion of physical control.MS does not spare any age group. The worldwide average age at diagnosis is 32, with an estimated 1.5% of all those with MS diagnosed before turning 18. Women receive an MS diagnosis at twice the rate of men. Within the United States alone, close to one million people are currently living with the disease in the United States, a number that more than doubled over earlier figures once researchers applied more rigorous, contemporary counting methods. Unfortunately, the trend continues upward, with prevalence climbing in every region of the world since 2013.In addition, MS is especially destructive because of its tendency to worsen progressively. Many patients initially experience a relapsing-remitting pattern, in which symptoms flare and then partially subside. Over time, however, a substantial share of patients shift into secondary progressive MS, a phase marked by steadily accumulating disability. According to the National MS Society, many people with MS end up juggling several medications at once, with each med addressing a separate symptom or relapse episode, yet none capable of confronting the underlying nerve damage that continues to erode their quality of life.The disease also imposes a substantial financial toll. The worldwide market for MS therapeutics was valued at roughly $27.4 billion in 2024 and is projected to climb to $38.62 billion by 2030, a trajectory driven not by curative treatments but by the sheer volume of patients requiring care across their lifetimes. That market dynamic highlights just how large the unmet need truly is. Patients require more than ongoing management; they need a therapy capable of interrupting the disease process itself.That is exactly the objective Quantum BioPharma has set out to achieve. The company is advancing Lucid-MS, a patented, first-in-class drug candidate unlike any therapy currently on the market, one engineered to act on the myelin sheath directly with the aim of preventing and protecting its breakdown.Acting Directly on the Myelin SheathThe majority of approved MS treatments function by modulating the immune system. They subdue or redirect the immune response responsible for attacking myelin, an approach that can lower relapse frequency and slow the buildup of disability. These therapies have delivered genuine clinical progress. Yet none of them directly address the myelin tissue itself or work to rebuild what has already been lost. For patients in the progressive stages of MS, immune modulation alone frequently proves inadequate.Lucid-MS charts an entirely separate course. Known technically as Lucid-21-302, the candidate is a patented New Chemical Entity, classified as a first-in-class, nonimmunomodulatory, neuroprotective compound. Instead of working through the immune system, Lucid-MS acts directly on the myelin sheath. In preclinical models, it has demonstrated the ability to protect myelin from degradation, a key pathological process underlying multiple sclerosis. No currently approved treatment offers a comparable mechanism of action.A defining feature of Lucid-MS is that it does not impact immune function. That quality separates it from most existing MS therapies and may translate into a meaningful safety benefit. It also frames Lucid-MS not as a substitute for immune-modulating drugs but as a potential complement to them, or should future trial results support its early promise, as a foundational therapy in its own right. The drug is also being advanced in an oral form, which would offer patients greater convenience than the injectable or infusion-based treatments many currently rely on.Quantum BioPharma controls exclusive global rights to Lucid-MS through its wholly owned subsidiary, Lucid Psycheceuticals Inc. The program is guided by a top-tier scientific team that includes advisor Dr. Lakshmi P. Kotra, recipient of the Julia Levy Award, a senior scientist at the University Health Network and a professor of medicinal chemistry at the University of Toronto. The scientific team also includes Dr. Andrzej Chruscinski, vice president of Scientific and Clinical Affairs, whose career spans Stanford-trained internal medicine alongside cardiology and neurological research. This group is working toward something no approved drug has yet accomplished: an MS therapy that directly safeguards myelin.From Laboratory Findings to Human StudiesThe scientific case behind Lucid-MS rests on years of disciplined research. The compound has undergone study for upward of a decade, with findings published in some of medicine's most respected journals, including the "Journal of Medicinal Chemistry" and the "Proceedings of the National Academy of Sciences." These peer-reviewed papers track the compound's indicated capacity to prevent demyelination in preclinical settings.The animal-model results are notable. Across experiments carried out in multiple laboratories over the course of several years, Lucid-MS sped up functional recovery in mouse models of MS, preserved myelin integrity and reduced regional degradation. Documented results report that, following treatment, mice regain the capability to walk. This outcome did not stem from isolated experiments but from an extensive body of studies. The results proved compelling enough to justify advancing the compound into human trials.Quantum BioPharma presented its phase 1 clinical trial application for Lucid-MS to evaluate first-in-human safety and tolerability in 2023. The trial encompassed both Single Ascending Dose ("SAD") and Multiple Ascending Dose ("MAD") phases, which were administered among healthy volunteers. Results from the clinical study report identified no safety or tolerability concerns associated with daily dosing. Dosing in phase 1 among healthy human volunteers was successfully completed, with Lucid-MS characterized as exhibiting a favorable safety profile and good tolerability.Should upcoming phase 2 trials in MS patients confirm what the preclinical work suggested — that Lucid-MS can stop and prevent myelin degradation — it would represent an unprecedented milestone. No therapy currently approved for MS has shown the ability to help patients regain physical function previously lost to myelin damage. While human trials remain necessary to determine whether the preclinical results carry over to patients, a decade's worth of accumulated data provides a scientifically credible basis for that optimism.Submitting the IND, Preparing for Phase 2Late last year, the company finished dosing in both 180-day, repeated-dose oral toxicity and toxicokinetic studies for Lucid-21-302. These studies represent essential elements of the Investigational New Drug ("IND") application that the U.S. Food and Drug Administration ("FDA") requires before authorizing a phase 2 trial. Completing these extended safety studies marked a meaningful advance toward formal regulatory submission.The company additionally entered into agreements with a leading contract development and manufacturing organization to develop and produce an oral formulation of Lucid-MS, a critical step in preparing the drug for clinical use. Following that, in April this year, Quantum BioPharma officially filed its IND application with the FDA for Lucid-MS, aiming for a phase 2 trial designed to assess the therapy's efficacy, safety and tolerability among people living with MS.To carry out a phase 2 trial, Quantum BioPharma announced a binding letter of intent with Allucent, a global contract research organization with extensive experience running central nervous system trials. Quantum BioPharma also named a principal investigator for the upcoming trial, marking further progress in the clinical development program. These steps are indicative of an organization that has advanced methodically from encouraging preclinical results to taking the steps towards producing the human clinical data the MS community is waiting for.A Pioneering Partnership Sheds Light on the Path ForwardQuantum BioPharma is concurrently working with a tool that could prove vital to assessing Lucid-MS's effectiveness: an advanced imaging technique capable of directly visualizing myelin within the living human brain. Quantum BioPharma recently launched a joint clinical study with researchers at Massachusetts General Hospital ("MGH") to validate a novel positron emission tomography imaging method for tracking myelin integrity and demyelination in MS.The study centers on a PET tracer known as [¹8F]3F4AP, developed by Dr. Pedro Brugarolas, who is an investigator in the Department of Radiology at MGH and an assistant professor at Harvard Medical School. Dr. Eric Klawiter, director of the Multiple Sclerosis and Neuromyelitis Optica Unit at MGH and an associate professor of neurology at Harvard Medical School, is co-investigator on the project.In June of last year, the first patient with MS was scanned successfully, which marked the formal start of active patient enrollment. The MGH research team also published encouraging results in the "European Journal of Nuclear Medicine and Molecular Imaging," in a study funded by the National Institutes of Health. The tracer exhibited strong properties for brain imaging and, notably, was able to distinguish differences among lesions that conventional MRI could not detect. Last month, the study reached the midpoint of patient enrollment, with preliminary imaging results showing encouraging signal strength in acute MS lesions.The importance of this imaging work to Lucid-MS's development is difficult to overstate. One of the central challenges in developing any remyelinating therapy is confirming whether it is genuinely working, and conventional MRI cannot provide a direct, quantitative measure of myelin. Assuming it is validated, the [¹8F]3F4AP tracer could supply precisely that: a real-time biological window into how effectively a drug is protecting or restoring the myelin sheath.Chruscinski has noted that this tool has the potential to fundamentally reshape how demyelination is assessed, offering a direct view into axonal health and enabling clearer demonstration of how therapies such as Lucid-MS perform. This collaboration among the University Health Network, Massachusetts General Hospital and researchers affiliated with Harvard Medical School brings together world-class scientific expertise around a common purpose.Quantum BioPharma is laser focused on that objective. With the global MS therapeutics market projected to surpass $38 billion by 2030, the commercial stakes involved are substantial. Yet for the nearly three million people living with MS worldwide, what matters most is whether a therapy can finally achieve what none has accomplished before: Halting the disease, repairing the damage it causes and restoring the bodily control that MS has taken away. Should Lucid-MS fulfill its preclinical promise in human trials, it would represent more than a new drug; it would mark a genuine turning point.Advancing Treatment Options Across SectorsRecent developments across the biopharmaceutical industry highlight continued momentum in the development of therapies for autoimmune, immune-mediated and chronic inflammatory diseases. Companies are reporting encouraging clinical results, expanding development programs and achieving important regulatory milestones as they work to address conditions that can significantly impact quality of life and often remain difficult to treat.Novartis AG (NYSE: NVS) presented data from the RemIND trial at the European Academy of Allergy and Clinical Immunology ("EAACI") Congress. The data showed that Rhapsido(R) (remibrutinib) met its primary endpoints across the three most common chronic inducible urticaria (CIndU) subtypes, becoming the first-ever treatment to demonstrate efficacy in a global Phase III CIndU clinical trial. In the RemIND trial, higher rates of complete responses were observed at week 12, with responses seen as early as week 2 in two subtypes. These results demonstrate that Rhapsido may provide sustained relief for patients whose disease remains inadequately controlled after treatment with second-generation H1-antihistamines.Merck & Co. Inc. NYSE: MRK) announced positive topline results from the phase 3 ATLAS-UC induction-only study (study 2). The study evaluated tulisokibart ("MK-7240"), an investigational humanized monoclonal antibody targeting tumor necrosis factor-like cytokine 1A ("TL1A"), in patients with moderately to severely active UC. The study successfully met its primary endpoint of clinical remission according to the Modified Mayo Score at week 12, as well as key secondary endpoints. In addition, consistent with previously reported phase 2 studies, no safety concerns were identified.TG Therapeutics Inc. (NASDAQ: TGTX) reported positive topline phase 1 data for subcutaneous BRIUMVI in patients with myasthenia gravis. The company also announced theinitiation of a phase 2 clinical trial evaluating BRIUMVI as a maintenance therapy following induction with efgartigimod in adult patients with MG. The company noted that the encouraging results support continued development of BRIUMVI in MG and also mark an important milestone in expanding the potential utility of BRIUMVI beyond multiple sclerosis.Bristol Myers Squibb Company (NYSE: BMY) announced that the European Commission has approved Opdivo(R) (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine for the treatment of adult and adolescent patients 12 years of age and older with previously untreated stage 3 or 4 classical Hodgkin lymphoma. This approval marks a significant milestone, establishing the Opdivo plus AVD combination as the first immunotherapy-based regimen available in the European Union for newly diagnosed advanced cHL.As scientific understanding of immune system dysfunction continues to evolve, researchers are uncovering new therapeutic targets and refining treatment strategies across a broad range of diseases. These efforts reflect a growing focus on delivering therapies that offer greater efficacy, convenience and durability while helping address substantial unmet medical needs.For further information about Quantum BioPharma Ltd., visit the Quantum BioPharma profile.About BioMedWireBioMedWire ("BMW") is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. 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Bristol Myers Squibb to Unveil New Data at ASCO® 2026 Demonstrating Strength and Breadth of Scientific Innovation Across Oncology Portfolio and Next-Generation PipelineMay 21, 2026 5:01 PM
Business Wire Late-breaking Phase 3 SUCCESSOR-2 study results highlight potential of mezigdomide, a novel CELMoD from the Company’s targeted protein degradation platform, in relapsed or refractory multiple myeloma Additional data from the Company’s differentiated pipeline including pumitamig, iza-bren, iberdomide and golcadomide to also be presented at meeting Bristol Myers Squibb (NYSE: BMY) today announced the presentation of data from its oncology portfolio and pipeline at the 2026 American Society of Clinical Oncology (ASCO®) Annual Meeting to be held May 29 – June 2 in Chicago, Illinois. Across more than 60 disclosures and 19 oral presentations, the Company will highlight progress from its differentiated oncology pipeline in solid tumors and hematologic malignancies. “This ASCO features the breadth of our oncology pipeline across multiple tumor types and different approaches such as bispecifics, ADCs and targeted therapies, and showcases the potential of our industry-leading CELMoD modality,” said Cristian Massacesi, MD, executive vice president, chief medical officer and head of Development, Bristol Myers Squibb. “Throughout the meeting, we will also highlight novel combinations that we believe could offer innovative and meaningful options to people with cancer.” Key data to be presented by Bristol Myers Squibb and its collaborators include: Delivering on the potential of targeted protein degradation with CELMoD (cereblon E3 ligase modulation) presentations in multiple myeloma and lymphoma Late-breaking full results from the Phase 3 SUCCESSOR-2 trial of mezigdomide, an investigational, oral CELMoD, in combination with carfilzomib and dexamethasone (MeziKd) versus carfilzomib and dexamethasone in relapsed or refractory multiple myeloma will be shared in an oral presentation Safety and 12-month efficacy results for golcadomide, a potential first-in-class investigational lymphoma CELMoD, in combination with pola-RCHP in patients with newly diagnosed aggressive B-cell lymphoma Efficacy and safety of iberdomide, an investigational, oral CELMoD, in combination with daratumumab, bortezomib and dexamethasone in patients with newly diagnosed multiple myeloma Exploring novel approaches across breast, gastric and lung cancers Two Phase 3 studies sponsored by SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin) in Mainland China: Late-breaking Phase 3 data for izalontamab brengitecan (iza-bren), a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC), versus physician's choice chemotherapy in patients with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer Phase 3 results for iza-bren versus chemotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma Outside of China, iza-bren is jointly developed by SystImmune and Bristol Myers Squibb In partnership with BioNTech, the first global data for a PD-1 or PD-(L)1 x VEGF bispecific immunomodulator in previously untreated non-small cell lung cancer (NSCLC): Phase 2 data for pumitamig (PD-L1 x VEGF-A bispecific antibody) in combination with chemotherapy in first-line NSCLC Expanding the evidence base for cell therapy and elevating real-world impact Real-world patient characteristics, outcomes, and resource utilization of chimeric antigen receptor (CAR) T cell therapy across Foundation for the Accreditation of Cellular Therapy (FACT) and non-FACT treatment centers in large B-cell lymphoma First results from the Center for International Blood and Marrow Transplant Research (CIBMTR) showing real-world outcomes of Breyanzi (lisocabtagene maraleucel) in patients with relapsed or refractory chronic lymphocytic leukemia and relapsed or refractory mantle cell lymphoma More details on these select studies to be presented at the 2026 Annual Meeting by the Company and its collaborators: Abstract Title Author Presentation Type / Abstract # Session Title Session Date/Time (CDT) Breast Cancer PANKU-Breast02: izalontamab brengitecan vs physician’s choice chemotherapy in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC): A randomized, Phase 3 study (BL-B01D1-307)(LBA) Wu, J Oral #LBA1003 Breast Cancer - Metastatic June 2, 2026 9:45 AM – 12:45 PM Gastrointestinal Cancer PANKU-Esophagus01: izalontamab brengitecan vs chemotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC), A multicenter, randomized, open-label, Phase 3 study (BL-B01D1-305) Lu, Z Oral #4008 Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary June 1, 2026 9:45 AM – 12:45 PM Lymphoma Golcadomide, a potential, first-in-class, oral CELMoD, + pola-RCHP in patients with newly diagnosed aggressive B-cell lymphoma: Safety and 12-month efficacy results Hoffman, M Oral #7011 Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia May 29, 2026 1:00 PM – 2:30 PM Real-world patient characteristics, outcomes, and resource utilization of chimeric antigen receptor (CAR) T cell therapy across Foundation for the Accreditation of Cellular Therapy (FACT) and non-FACT treatment centers in large B-cell lymphoma Raj, R Poster #7023 Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia June 1, 2026 9:00 AM – 12:00 PM Real-world outcomes of lisocabtagene maraleucel in patients with relapsed or refractory chronic lymphocytic leukemia: First results from CIBMTR Tomasulo, E Poster #7024 Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia June 1, 2026 9:00 AM – 12:00 PM Outcomes of lisocabtagene maraleucel in patients with relapsed or refractory mantle cell lymphoma: First real-world data from the CIBMTR Huang, J Poster #7026 Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia June 1, 2026 9:00 AM – 12:00 PM Multiple Myeloma Efficacy and safety of iberdomide, daratumumab, bortezomib and dexamethasone in patients with newly diagnosed multiple myeloma Kapoor, P Oral #7514 Hematologic Malignancies – Plasma Cell Dyscrasia May 31, 2026 9:45 AM – 11:15 AM Mezigdomide, carfilzomib, and dexamethasone vs carfilzomib and dexamethasone in relapsed or refractory multiple myeloma: Result from the Phase 3 SUCCESSOR-2 trial (LBA) Richardson, P Oral #LBA7506 Hematologic Malignancies – Plasma Cell Dyscrasia May 29, 2026 2:45 PM – 5:45 PM Thoracic Cancer Phase 2 data from ROSETTA Lung-02, a global randomized Phase 2/3 trial of pumitamig (PD-L1 x VEGF-A bsAB) + chemotherapy in 1L NSCLC Peters, S Rapid Oral #8513 Lung Cancer – Non-Small Cell Metastatic May 30, 2026 1:15 PM – 2:45 PM BREYANZI INDICATIONS BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have: refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or relapsed or refractory disease after two or more lines of systemic therapy. Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma. adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least 2 prior lines of systemic therapy. IMPORTANT SAFETY INFORMATION WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids. Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA-and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Cytokine Release Syndrome Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. In clinical trials of BREYANZI, which enrolled a total of 769 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 56% of patients, including ≥ Grade 3 CRS in 3.4% of patients. The median time to onset was 5 days (range: 1 to 63 days). CRS resolved in 99% of patients with a median duration of 5 days (range: 1 to 37 days). One patient had fatal CRS and 5 patients had ongoing CRS at the time of death. The most common manifestations of CRS (≥10%) were fever, hypotension, chills, tachycardia, hypoxia, and headache. Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI. Neurologic Toxicities Neurologic toxicities that were fatal or life-threatening, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred following treatment with BREYANZI. Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, also occurred. In clinical trials of BREYANZI, CAR T cell-associated neurologic toxicities occurred in 32% of patients, including ≥ Grade 3 cases in 10% of patients. The median time to onset of neurotoxicity was 8 days (range: 1 to 63 days). Neurologic toxicities resolved in 88% of patients with a median duration of 7.5 days (range: 1 to 119 days). Of patients developing neurotoxicity, 83% also developed CRS. The most common neurologic toxicities (≥5%) included encephalopathy, tremor, aphasia, delirium, and headache. CRS and Neurologic Toxicities Monitoring Monitor patients daily for at least 7 days following BREYANZI infusion for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Continue to monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 2 weeks after infusion and treat promptly. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Manage neurologic toxicity with supportive care and/or corticosteroid as needed. Advise patients to avoid driving for at least 2 weeks following infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time. Hypersensitivity Reactions Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO). Serious Infections Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. In clinical trials of BREYANZI, infections of any grade occurred in 33% of patients, with Grade 3 or higher infections occurring in 12% of all patients. Grade 3 or higher infections with an unspecified pathogen occurred in 7%, bacterial infections in 3.5%, viral infections in 2%, and fungal infections in 0.7% of patients. One patient who received 4 prior lines of therapy developed a fatal case of John Cunningham (JC) virus progressive multifocal leukoencephalopathy 4 months after treatment with BREYANZI. One patient who received 3 prior lines of therapy developed a fatal case of cryptococcal meningoencephalitis 35 days after treatment with BREYANZI. Febrile neutropenia developed after BREYANZI infusion in 8% of patients. Febrile neutropenia may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated. Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines. Avoid administration of BREYANZI in patients with clinically significant, active systemic infections. Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. In clinical trials of BREYANZI, 35 of 38 patients with a prior history of HBV were treated with concurrent antiviral suppressive therapy. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines. Prolonged Cytopenias Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. In clinical trials of BREYANZI, Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 35% of patients, and included thrombocytopenia in 25%, neutropenia in 22%, and anemia in 6% of patients. Monitor complete blood counts prior to and after BREYANZI administration. Hypogammaglobulinemia B-cell aplasia and hypogammaglobulinemia can occur in patients receiving BREYANZI. In clinical trials of BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in 9% of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 30% of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated. Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI. Secondary Malignancies Patients treated with BREYANZI may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol-Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing. Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS) Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Seven out of 769 (0.9%) patients with R/R NHL exposed to BREYANZI developed IEC-HS. Time to onset of IEC-HS ranged from 7 to 32 days. Of the 7 patients, 3 patients developed IEC-HS with overlapping occurrence of CRS and neurotoxicity, 2 patients developed IEC-HS with overlapping occurrence of neurotoxicity, and 1 patient developed IEC-HS with overlapping occurrence of CRS. IEC-HS was fatal in 2 of 7 patients. One patient had fatal IEC-HS and one had ongoing IEC-HS at time of death. IEC-HS is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of IEC-HS should be administered per current practice guidelines. Adverse Reactions The most common adverse reaction(s) (incidence ≥30%) in: LBCL are fever, CRS, fatigue, musculoskeletal pain, and nausea. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease. CLL/SLL are CRS, encephalopathy, fatigue, musculoskeletal pain, nausea, edema, and diarrhea. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease. FL is CRS. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease. MCL are CRS, fatigue, musculoskeletal pain, and encephalopathy. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, and platelet count decrease. MZL is CRS. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide. About Bristol Myers Squibb: Transforming Patients’ Lives Through Science
At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram. Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that pumitamig, iza-bren, iberdomide, golcadomide, mezigdomide, nivolumab, ipilimumab, pomalidomide, arlocabtagene autoleucel (arlo-cel), relatlimab, adagrasib, lisocabtagene maraleucel, BMS-986365, BMS-986504, or BMS-986489 alone, in combination with standard therapies, or in combinations as described herein, may not achieve its primary study endpoints or receive regulatory approval for the indications described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such products, treatments, or combination treatments for such indications will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. corporatefinancial-news View source version on businesswire.com: https://www.businesswire.com/news/home/20260521520759/en/ Bristol Myers Squibb Media Inquiries:
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investor.relations@bms.com Original: Bristol Myers Squibb to Unveil New Data at ASCO® 2026 Demonstrating Strength and Breadth of Scientific Innovation Across Oncology Portfolio and Next-Generation Pipeline
US Market News
1月前
Bristol Myers Squibb Announces Strategic Agreement with Anthropic to Position Claude Enterprise as the Shared Intelligence Platform Across Its Global OperationsMay 20, 2026 6:59 AM
Business Wire The collaboration brings together BMS’ deep scientific expertise and Anthropic's frontier AI to accelerate the discovery, development and delivery of transformational medicines BMS will deploy Claude's agentic capabilities, moving beyond conversational AI, to connect its people, systems and institutional knowledge at enterprise scale Bristol Myers Squibb (NYSE:BMY, "BMS"), a global biopharmaceutical leader, today announced a strategic agreement with Anthropic to deploy Claude across the company's research, clinical development, manufacturing, commercial, and corporate functions. The collaboration signals a meaningful evolution in how BMS deploys AI, moving beyond conversational tools that have defined the first wave of enterprise adoption, toward agentic capabilities built into the day-to-day workflows and systems that underpin its science and global operations. BMS will deploy Claude broadly across the company, empowering more than 30,000 employees with advanced reasoning and agentic capabilities. The deployment focuses on three priorities where BMS expects the highest near-term impact: Accelerating engineering with Claude Code. BMS' engineering and data science teams will leverage Claude Code to speed software and AI development. By standardizing how they build and deploy capabilities across the enterprise, teams can unlock data and expertise long trapped in the disconnected systems that define biopharma today. Embedding agents into the workflows that move drugs forward. BMS will evaluate the potential for Claude to serve as the agentic layer within priority workflows where AI is already driving impact across the value chain, including: Research: Applying advanced AI reasoning to decades of BMS' proprietary scientific, molecular, and clinical data, further enabling researchers to synthesize, interrogate, and extract predictive insights that accelerate target identification and optimization across oncology, hematology, neuroscience, and immunology. Drug development: Bringing intelligent automation to the full arc of trial documentation, from drafting clinical study reports and patient safety narratives to supporting regulatory submissions, with the potential to compress the time between data lock and filing. Manufacturing & quality: Enabling end-to-end acceleration across product development and manufacturing, from root-cause investigation and Corrective and Preventive Action documentation to data-driven batch release decisions - strengthening quality and compliance, accelerating decision-making, and delivering medicines to patients faster and more reliably. Commercial & medical affairs: Turning field insights into structured intelligence that enables more personalized and timely engagement with healthcare professionals, helping BMS connect the right information to the right people at the moments that matter most in their practice. Connecting Claude to the institutional knowledge that lives across BMS. Through secure integrations with the systems and repositories where BMS' scientific, clinical, regulatory, and commercial expertise resides, Claude's agentic capabilities will help connect and activate that knowledge where and when it is most needed, with full enterprise governance and audit controls in place. The collaboration builds on more than three years of AI investment at BMS, where the company has given employees unlimited access to leading frontier models through a proprietary internal platform. Those investments have established BMS as a leader in AI integration across research, clinical development, manufacturing and commercial functions, and reflect a deliberate multi-vendor strategy that draws on the best capabilities the industry has to offer. "For more than 160 years, BMS has pushed the boundaries of science to transform patients' lives, and artificial intelligence is the single most powerful opportunity we have to accelerate that mission today," said Greg Meyers, EVP and Chief Digital & Technology Officer, Bristol Myers Squibb. "Most enterprise AI stops at the chatbot. The real prize is the untapped value still trapped behind decades of data silos, and this collaboration is how we reach it. Anthropic’s Claude gives us the agentic capabilities, pace of innovation, and security necessary to connect our systems and put that collective knowledge in the hands of every BMS employee to accelerate innovation for patients. The companies that lead the next decade of biopharma will be the ones that learn to operate fundamentally differently with AI, and BMS intends to be one of them." "By giving employees access to Claude’s agentic capabilities — connected to thousands of data sources across the company — BMS is creating a single intelligence layer that can generate a clinical study report from underlying trial data, surface the right scientific context from decades of internal research, or trace the root cause of a manufacturing deviation in real time,” said Eric Kauderer-Abrams, Head of Life Sciences, Anthropic. “In a regulated global enterprise, that means medicines reach patients faster — with BMS’ scientific depth and operational rigor accelerated by Claude agents at every step.” About Bristol Myers Squibb: Transforming Patients' Lives Through Science At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what's possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram. Cautionary Statement Regarding Forward-Looking Statement This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products and the strategic agreement with Anthropic. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our actual future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the expected benefits of, and opportunities related to, the agreement may not be realized by Bristol Myers Squibb or may take longer to realize than anticipated. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. corporatefinancial-news View source version on businesswire.com: https://www.businesswire.com/news/home/20260520213849/en/ Media:
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investor.relations@bms.com Original: Bristol Myers Squibb Announces Strategic Agreement with Anthropic to Position Claude Enterprise as the Shared Intelligence Platform Across Its Global Operations
US Market News
2月前
Bristol Myers Squibb Receives European Commission Approval of Sotyktu (deucravacitinib) for the Treatment of Active Psoriatic Arthritis in AdultsMay 8, 2026 6:59 AM
Business Wire In the pivotal Phase 3 POETYK PsA clinical trials, Sotyktu demonstrated superiority compared with placebo at Week 16 across multiple endpoints, including skin and joint symptoms, with improvements in quality of life as reflected in the European Union Summary of Product Characteristics (SmPC) Sotyktu, a once-daily oral treatment, is the first and only tyrosine kinase 2 (TYK2) inhibitor to be approved in the European Union for this indication Bristol Myers Squibb (NYSE:BMY) today announced that the European Commission has granted approval to Sotyktu (deucravacitinib), alone or in combination with methotrexate, for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic (DMARD) therapy. Sotyktu, a once-daily oral, selective tyrosine kinase 2 (TYK2) inhibitor, is the first TYK2 inhibitor to be approved for the treatment of active PsA in the European Union (EU). “The European approval of Sotyktu for active psoriatic arthritis represents an important advancement in addressing both the skin and joint symptoms of this chronic immune-mediated disease,” said Al Reba, senior vice president, Cardiovascular & Immunology Commercialization, Bristol Myers Squibb. “This milestone marks a new approach to treating psoriatic arthritis, and we look forward to continuing the development of Sotyktu for other serious rheumatic conditions as part of our commitment to addressing the life-altering impact of these diseases.” This EU approval is based on positive results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 clinical trials, which evaluated the efficacy and safety of Sotyktu 6 mg once daily in adults with active PsA. In both trials, treatment with Sotyktu resulted in significant improvement in disease activity, as measured by American College of Rheumatology (ACR) 20 (the primary endpoint) and Minimal Disease Activity (MDA) (key secondary endpoint). The overall safety profile of Sotyktu observed in individuals with active psoriatic arthritis was generally consistent with the safety profile in those with plaque psoriasis. The most common adverse reactions (≥1%) are upper respiratory infections, blood creatine phosphokinase increased, herpes simplex infections, oral ulcers, acneiform rash and folliculitis. Sotyktu is associated with the following special warnings and precautions for use: infections; pre-treatment evaluation for tuberculosis; malignancies; major adverse cardiovascular events, deep venous thrombosis and pulmonary embolism; immunizations; and excipients (lactose, sodium). “Psoriatic arthritis presents differently from patient to patient, often combining widespread musculoskeletal inflammation and challenging skin symptoms with a debilitating impact on quality of life,” said Frank Behrens, MD, Professor of Rheumatology, Immunology, and Inflammation Medicine, Goethe-University Hospital, Frankfurt. “The impressive safety and the efficacy profile observed in the pivotal POETYK PsA trials demonstrate the ability of Sotyktu, the first approved TYK2 inhibitor, to provide comprehensive relief for adults living with this chronic, immune-mediated inflammatory disease.” In clinical trials, health-related quality of life was assessed by the 36-Item Short Form Health Survey (SF-36). Patients treated with Sotyktu showed improvements in SF-36 Physical Component Summary (PCS) score at Week 16 compared to placebo (key secondary endpoint), with improvements maintained in both POETYK PsA trials up to Week 52. Sotyktu was approved by the U.S. Food and Drug Administration (FDA) on March 6, 2026 for the treatment of adults with active PsA. Sotyktu was first approved in 2022 by the U.S. FDA for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. Per that approval, Sotyktu is not recommended for use with other potent immunosuppressants in the PsO population. In 2023, Sotyktu was approved by the European Commission for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Since then, multiple global regulatory authorities have approved Sotyktu for that indication. Sotyktu has five years of clinical efficacy and safety data in patients with moderate-to-severe plaque psoriasis. Bristol Myers Squibb thanks the patients and investigators who participated in the POETYK PsA clinical trials. About Psoriatic Arthritis Psoriatic arthritis (PsA) is a chronic, immune-mediated, heterogenous disease with multiple musculoskeletal and skin manifestations, including inflammatory arthritis, enthesitis (inflammation where tendon or ligament attaches to the bone), dactylitis (swelling of finger and toe joints) and psoriatic skin and nail lesions. Up to 30 percent of patients with psoriasis go on to develop PsA. In addition to impairments in physical function, pain and fatigue caused by PsA, the disease can significantly impact the well-being of patients. Patients with PsA are also at increased risk of serious comorbidities. About the Sotyktu Phase 3 Psoriatic Arthritis Trial Program The Phase 3 Sotyktu psoriatic arthritis (PsA) program includes two Phase 3, multicenter, randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety in adults 18 years of age and older with active PsA: POETYK PsA-1 (IM011-054; NCT04908202) and POETYK PsA-2 (IM011-055; NCT04908189). POETYK PsA-1 included 670 patients with active PsA who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD naïve). POETYK PsA-2 included 624 patients with active PsA who were bDMARD naïve or had previously received TNFa inhibitor treatment. Patients met the CASPAR criteria for PsA, with ≥3 swollen and ≥3 tender joints and had an active or documented history of plaque psoriasis. Both trials include a 52-week treatment period comprised of a placebo-controlled treatment period through Week 16, followed by a reallocation and continued active treatment period from Week 16 to Week 52. POETYK PsA-2 also included an apremilast safety reference arm. The primary endpoint of both trials was the proportion of participants achieving an ACR20 response at Week 16. Key secondary endpoints were also assessed at Week 16 across measures of PsA disease activity. Patients in both trials completing 52 weeks of treatment were potentially eligible to enroll in open-label extensions. In both POETYK PsA-1 and POETYK PsA-2 trials, treatment with Sotyktu resulted in significant improvement in disease activity, as measured by American College of Rheumatology (ACR) 20 (the primary endpoint) and Minimal Disease Activity (MDA) (key secondary endpoint). Efficacy Results in Adults with Psoriatic Arthritis POETYK PsA-1 POETYK PsA-2 Sotyktu (N = 336) Placebo (N = 334) Difference from Placebo (95% CI) Sotyktu (N = 312) Placebo (N = 312) Difference from Placebo (95% CI) ACR20 Response Week 16 (%) 54.2 34.1 20.0 (12.7, 27.4) a 54.2 39.4 14.8 (7.0, 22.5) a Week 52 (%) * 76.3 (212/278) 71.9 (194/270) ACR50 Response Week 16 (%) 24.7 13.5 11.2 (5.3, 17.1) c 28.8 16.3 12.5 (6.0, 19.0) c Week 52 (%) * 48.9 (136/278) 47.0 (127/270) ACR70 Response Week 16 (%) 11.6 5.4 6.2 (2.0, 10.4) d 10.6 5.4 5.2 (0.9, 9.4) d Week 52 (%) * 30.2 (84/278) 30.0 (81/270) Minimal disease activity (MDA)** Response Week 16 (%) 19.0 10.2 8.9 (3.6, 14.2) b 25.6 14.7 10.9 (4.6, 17.1) b Week 52 (%) * 40.7 (114/280) 48.3 (130/269) Non-responder imputation (NRI) was used up to Week 16. After Week 16, observed data is shown with no imputation. N is number of randomized patients. a p≤0.0002 b p≤0.001 c Nominal p≤0.0002 d Nominal p≤0.02 * Data are shown for available subjects in the format of % (n/N) observed ** Minimal disease activity (MDA) = 5 out of 7 outcomes: tender joint count ≤1; swollen joint count ≤1; Psoriasis Activity and Severity Index ≤1 or body surface area ≤3%; patient pain visual analogue scale (VAS) ≤15; patient global disease activity VAS ≤20; Health Assessment Questionnaire Disability Index ≤0.5; tender entheseal points ≤1 About Sotyktu (deucravacitinib) Sotyktu is an oral, selective, tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action. It is the first selective TYK2 inhibitor in clinical studies across moderate-to-severe plaque psoriasis and active psoriatic arthritis. Bristol Myers Squibb scientists designed Sotyktu to selectively target TYK2, thereby mediating the signaling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key cytokines involved in the pathogenesis of plaque psoriasis and psoriatic arthritis. Sotyktu achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in inhibition of TYK2 and mediation of its downstream functions. Sotyktu has been shown to have high selectivity for TYK2 at physiologically relevant concentrations and has not been shown to inhibit JAK1, JAK2 or JAK3 in in vitro assays. The precise mechanism linking inhibition of TYK2 enzyme to therapeutic effectiveness is not currently known. Sotyktu is approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis and is also approved in the United States for the treatment of active psoriatic arthritis in adults. The efficacy and safety of Sotyktu in patients with moderate-to-severe plaque psoriasis were evaluated in POETYK PSO-1 and POETYK PSO-2, multi-national, randomized, double-blind, placebo- and active comparator-controlled 52-week Phase 3 studies. In total, 664 patients were enrolled in POETYK PSO-1, and 1,020 patients were enrolled in POETYK PSO-2. All participants had moderate-to-severe plaque psoriasis and were candidates for phototherapy or systemic therapy. Bristol Myers Squibb: Pioneering Paths Forward in Immunology to Transform Patients’ Lives Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can make simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, we continue to pursue bold science as we work to deliver life-changing medicines that elevate new standards of care across rheumatology, dermatology and pulmonology. Our sequential immunotherapy research framework aims to address the root cause of disease by controlling inflammation, resetting the immune system and promoting immune homeostasis with the goal of achieving transformational efficacy. By continuously pushing the boundaries of scientific knowledge, we strive to bring forward tailored approaches, treatments and combinations that may lead to durable remissions, improved quality of life and functional cures. Our collaborations with patients, caregivers, healthcare providers and researchers inform our patient-centric approach as we aim to break efficacy ceilings and deliver what matters most — the promise of living a better life. Full European Summary of Product Characteristics for Sotyktu will be found on the EMA website at www.ema.europa.eu. Sotyktu U.S. Indications and Important Safety Information IMPORTANT SAFETY INFORMATION INDICATIONS SOTYKTU® (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Limitations of Use: SOTYKTU is not recommended for use in combination with other potent immunosuppressants. SOTYKTU® is indicated for the treatment of active psoriatic arthritis in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU. Infections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of SOTYKTU prior to initiating treatment in patients: with chronic or recurrent infection who have been exposed to tuberculosis with a history of a serious or an opportunistic infection with underlying conditions that may predispose them to infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated, and be closely monitored. Interrupt SOTYKTU if a serious infection occurs. Do not resume SOTYKTU until the infection resolves or is adequately treated. Viral Reactivation Herpes virus reactivation (e.g., herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. In the 16-week placebo-controlled period of Trials PSO-1 and PSO-2, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multidermatomal herpes zoster was reported in an immunocompetent patient. The clinical implications of SOTYKTU on viral hepatitis reactivation are unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C. Tuberculosis (TB): In trials of PSO-1 and PSO-2, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment. Malignancy including Lymphomas: Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy during treatment with SOTYKTU. Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo. Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Laboratory Abnormalities: Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. Treatment with SOTYKTU has been associated with liver enzyme elevation. Evaluate liver enzymes at baseline and during treatment with SOTYKTU in patients with known or suspected liver disease according to routine management. If increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded. Immunizations: Prior to initiating therapy with SOTYKTU, complete all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated. Potential Risks Related to JAK Inhibition: It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, postmarketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA. ADVERSE REACTIONS Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) in patients with plaque psoriasis include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne. The overall safety profile of SOTYKTU observed in patients with active psoriatic arthritis was generally consistent with the safety profile observed in patients with plaque psoriasis. SPECIFIC POPULATIONS Pregnancy: Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072. Lactation: There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition. Hepatic Impairment: SOTYKTU is not recommended for use in patients with severe hepatic impairment. SOTYKTU is available in 6 mg tablets. Please see U.S. Full Prescribing Information, including Medication Guide, for SOTYKTU. SOTYKTU and the SOTYKTU logo are trademarks of Bristol-Myers Squibb Company. © 2026 Bristol-Myers Squibb Company About Bristol Myers Squibb: Transforming Patients’ Lives Through Science At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram. Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, whether the outcome of pricing and reimbursement negotiations in individual countries in Europe may delay or limit the commercial potential of Sotyktu (deucravacitinib) for the additional indication described in this release, that it will be commercially successful, any marketing approvals, if granted, may have significant limitations on their use and that continued approval of Sotyktu for such indication may be contingent upon verification and description of clinical benefit in confirmatory trials. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. corporatefinancial-news View source version on businesswire.com: https://www.businesswire.com/news/home/20260507663929/en/ Bristol Myers Squibb Media Inquiries:
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investor.relations@bms.com Original: Bristol Myers Squibb Receives European Commission Approval of Sotyktu (deucravacitinib) for the Treatment of Active Psoriatic Arthritis in Adults
US Market News
2月前
Bristol Myers Squibb and Pfizer to Make Eliquis® (apixaban) Available via Mark Cuban Cost Plus Drug CompanyApril 24, 2026 6:59 AM
Business Wire
Expands Options for Cash-Paying Patients to Access the Nation’s #1 Prescribed Oral Blood Thinner
The Bristol Myers Squibb-Pfizer (BMS NYSE: BMY) — (Pfizer NYSE: PFE) Alliance today announced the launch of a collaboration with Mark Cuban Cost Plus Drug Company (Cost Plus Drugs) to offer Eliquis® (apixaban) on CostPlusDrugs.com. Eliquis is one of the most widely prescribed oral anticoagulants in the United States and one of the largest brands in the space to be offered on the site, which allows patients to purchase prescription medicines directly at reduced costs, providing another avenue for patients to access the medication.
“The BMS-Pfizer Alliance is pleased to expand our direct-to-patient options for accessing Eliquis — a medicine relied upon by millions of Americans daily — to the popular Cost Plus Drugs platform,” said Adam Lenkowsky, chief commercial officer, Bristol Myers Squibb. “This new collaboration is grounded in a shared commitment to transparency and offers another meaningful solution to overcome access barriers, lower costs and broaden the availability of our medicines for the patients who need them.”
Mark Cuban, co-founder, Cost Plus Drugs said, “We’ve heard from a lot of people asking for Eliquis on Cost Plus Drugs, and this is about making sure they have a clearer, more direct way to access it. People shouldn’t have to guess what they’re going to pay for a medication they depend on. When you strip away the layers that drive up costs, you give people more control over how they get their prescriptions.”
Beginning April 27, 2026, Eliquis will be available on Cost Plus Drugs, and patients with a prescription will pay a total of $345 for a 30-day supply. Teaming up with Cost Plus Drugs provides another option for cash-paying patients to access Eliquis directly. This follows the 2025 launch of a direct-to-patient offering through the BMS-Pfizer Alliance’s patient resource Eliquis 360 Support, which is also accessible via BMS Patient Connect.
Eliquis is an important treatment option for patients with atrial fibrillation (AFib), not caused by a heart valve problem, to reduce the risk of stroke and blood clots, as well as to treat blood clots in the veins of the legs (deep vein thrombosis [DVT]) or lungs (pulmonary embolism [PE]), and reduce the risk of them recurring. For every 100,000 patients treated, Eliquis has resulted in an estimated $3 billion in total healthcare cost savings and avoidance, such as hospitalization and extended rehabilitation needs.
ELIQUIS U.S. Indications and Important Safety Information
Indications
ELIQUIS is a prescription medicine used in adults to:
- Reduce the risk of stroke and blood clots in people who have atrial fibrillation (AFib), a type of irregular heartbeat, not caused by a heart valve problem
- Treat blood clots in the veins of the legs (deep vein thrombosis – DVT) or lungs (pulmonary embolism – PE), and reduce the risk of them occurring again after receiving treatment for blood clots
- Help prevent a blood clot in the legs (DVT) and lungs (PE) of people who have just had hip or knee replacement surgery
Important Safety Information
ELIQUIS is a prescription medicine used in children from birth and older to treat blood clots in the veins of the legs and lungs (venous thromboembolism) after at least 5 days of initial coagulant treatment, and reduce the risk of them occurring again. ELIQUIS was not studied and is not recommended in children who weigh less than 5.7 pounds (2.6 kg).
ELIQUIS may cause serious side effects, including:
Increased risk of blood clots if you stop taking ELIQUIS. ELIQUIS lowers your chance of having a stroke by helping to prevent clots from forming. Do not stop taking ELIQUIS without talking to the healthcare provider who prescribed it for you. Stopping ELIQUIS increases your risk of having a stroke.
ELIQUIS may need to be stopped prior to surgery or a medical or dental procedure. Your healthcare provider will tell you when you should stop taking ELIQUIS and when you may start taking it again. If you have to stop taking ELIQUIS, your healthcare provider may prescribe another medicine to help prevent a blood clot from forming.
ELIQUIS can cause bleeding, which can be serious, and may lead to death. This is because ELIQUIS is a blood thinner medicine that reduces blood clotting.
You may have a higher risk of bleeding if you take ELIQUIS and take other medicines that increase your risk of bleeding, such as aspirin, nonsteroidal anti-inflammatory drugs (called NSAIDs), warfarin, heparin, clopidogrel, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), and other medicines to help prevent or treat blood clots.
Tell your healthcare provider about all the medicines you or your child take, including any over-the-counter medicines, vitamins, and herbal supplements.
While taking ELIQUIS, you may bruise more easily and it may take longer than usual for any bleeding to stop.
Call your healthcare provider or get medical help right away if you or your child have any of these signs or symptoms of bleeding when taking ELIQUIS:
unexpected bleeding or bruising, or bleeding that lasts a long time, such as unusual bleeding from the gums, nose bleeds that happen often, or menstrual or vaginal bleeding that is heavier than normal
bleeding that is severe or you cannot control
red, pink, or brown urine; red or black stools (looks like tar)
coughing up or vomiting blood or vomit that looks like “coffee grounds”
unexpected pain, swelling, or joint pain
headaches, or feeling dizzy or weak
Spinal or epidural blood clots (hematoma). People who take ELIQUIS, and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:
a thin tube called an epidural catheter is placed in your back to give you certain medicine
you take NSAIDs or a medicine to prevent blood from clotting
you have a history of difficult or repeated epidural or spinal punctures
you have a history of problems with your spine or have had surgery on your spine
If you take ELIQUIS and receive spinal anesthesia or have a spinal puncture, your healthcare provider should watch you closely for symptoms of spinal or epidural blood clots or bleeding. Tell your healthcare provider or get medical help right away if you have back pain, tingling, numbness, or muscle weakness, especially in your legs and feet, or loss of control of the bowels or bladder (incontinence).
ELIQUIS is not for use in people with artificial heart valves.
ELIQUIS is not for use in people with antiphospholipid syndrome (APS), especially with positive triple antibody testing.
Do not take ELIQUIS if you or your child currently have certain types of abnormal bleeding or have had a severe allergic reaction to ELIQUIS or any of the ingredients.
Before taking ELIQUIS, tell your healthcare provider about all your medical conditions, including if you or your child have or ever had bleeding problems, have kidney or liver problems, or have antiphospholipid syndrome. Tell your healthcare provider right away if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed. Taking ELIQUIS during pregnancy may increase the risk of bleeding in you or in your unborn baby. Do not breastfeed during treatment with ELIQUIS. Females who are able to become pregnant: talk with your healthcare provider about pregnancy planning, and your risk of severe uterine bleeding if you are treated with ELIQUIS.
Take ELIQUIS exactly as prescribed by your healthcare provider. Take ELIQUIS twice every day, and do not change your dose or stop taking it unless your healthcare provider tells you to. If you or your child misses a dose of ELIQUIS, take it as soon as you remember on the same day, and do not take 2 doses at the same time to make up for a missed dose. Do not stop taking ELIQUIS without first talking with your healthcare provider. Do not run out of ELIQUIS. Refill your prescription before you run out. When leaving the hospital following hip or knee replacement, be sure that you will have ELIQUIS available to avoid missing any doses.
For children who take ELIQUIS, see the detailed Instructions for Use on how to prepare and give a dose of ELIQUIS. Always give ELIQUIS exactly as your child’s healthcare provider or pharmacist has told you. Do not change your child’s dose without talking with the healthcare provider. If a child vomits or spits up within 30 minutes after taking ELIQUIS, repeat the dose. If a child vomits or spits up more than 30 minutes after taking ELIQUIS, do not repeat the dose. Contact the healthcare provider if your child repeatedly vomits or spits up after taking ELIQUIS.
The most common side effect of ELIQUIS in adults was bleeding.
The most common side effects of ELIQUIS in children include headache, vomiting, and heavy menstrual bleeding.
Please see U.S. Full Prescribing Information, including Boxed WARNINGS, and Medication Guide.
About Bristol Myers Squibb: Transforming Patients’ Lives Through Science
At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
About the Bristol Myers Squibb-Pfizer Collaboration
The Bristol Myers Squibb-Pfizer Alliance (the Alliance) is committed to driving education and awareness about atrial fibrillation and deep vein thrombosis (DVT) and/or pulmonary embolism (PE). With long-standing cardiovascular leadership, global scale and expertise in this field, the Alliance strives to implement global, research-driven approaches to illuminate and address the unmet needs around strokes related to non-valvular atrial fibrillation, which are often fatal or debilitating. Through collaborations with non-profit organizations, the Alliance aims to provide patients, healthcare professionals and decision makers with the information they need to understand and take appropriate action on risk factors associated with stroke and other cardiovascular conditions.
BMS Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products and the Bristol-Myers Squibb-Pfizer Alliance. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the expected benefits of the collaboration with Cost Plus Drugs may not be realized by Bristol Myers Squibb. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
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View source version on businesswire.com: https://www.businesswire.com/news/home/20260423892519/en/
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Original: Bristol Myers Squibb and Pfizer to Make Eliquis® (apixaban) Available via Mark Cuban Cost Plus Drug Company
US Market News
3月前
Open Label Outpatient Switch Study Demonstrates Symptom Stability During Transition from Oral Atypical Antipsychotics to Cobenfy™ (xanomeline and trospium chloride)March 28, 2026 7:00 AM
Business Wire
High treatment completion and no discontinuations due to lack of efficacy observed across faster and slower switch strategies
Bristol Myers Squibb (NYSE: BMY) today announced data from a Phase 4 clinical trial evaluating the symptom stability, safety and tolerability of Cobenfy (xanomeline and trospium chloride) when switching adult outpatients with schizophrenia from an oral atypical antipsychotic to Cobenfy monotherapy. Through 8 weeks, patients remained stable with mean Positive and Negative Syndrome Scale (PANSS) total scores remaining below baseline, and no new safety signals were observed, regardless of cross-titration duration. These findings provide important evidence to help inform treatment switch strategies in clinical practice. Data were presented at the 2026 Annual Congress of the Schizophrenia International Research Society (SIRS) taking place March 25-29 in Florence, Italy.
“While transitioning patients is common in schizophrenia, clinicians have historically had limited data to help guide these decisions, especially for differentiated treatments like Cobenfy,” said David Walling, PhD, principal investigator and chief clinical officer at Cenexel – CNS. “The data presented today provide much-needed insight into what happens during a switch to Cobenfy, notably that patients remained stable through 8 weeks of treatment regardless of a slower or faster cross-titration, which will help healthcare professionals make informed treatment decisions for adults living with schizophrenia.”
This 8-week, open-label trial evaluated two cross-titration strategies in adults with schizophrenia (n=105): tapering the existing atypical antipsychotic down over the faster 2 week (n=52) or slower 4 week (n=53) period while simultaneously up-titrating Cobenfy to the target dose of 125/30 mg BID, over two weeks in both arms. Patients were required to have a PANSS total score at or below 80 at screening and baseline, Clinical Global Impression-Severity (CGI-S) score of ≤4, and to be on a stable dose of an oral atypical antipsychotic for at least 6 weeks.
The primary objective of the trial was to evaluate the rate of all-cause Cobenfy discontinuation over a period of 8 weeks. Key secondary endpoints included Cobenfy discontinuation due to a lack of efficacy, incidence of, and discontinuations due to adverse events (AEs), change from baseline (CFB) to week 8 in the PANSS total score, CGI-S, Personal and Social Performance (PSP), and Medication Satisfaction Questionnaire (MSQ).
In the trial, approximately 86% of patients completed 8 weeks of treatment, with discontinuation rates of 15.1% (n=8) and 13.5% (n=7) in the slower and faster transition groups. No patients discontinued treatment with Cobenfy due to lack of efficacy. Mean changes in PANSS total scores from baseline to week 8 were -4.2 in the slower transition group and -3.1 in the faster transition group. Mean change in CGI-S scores was -0.2 in both the slower and faster transition groups. From baseline to week 8, mean PSP scores improved by 1.1 and 0.7 in the slower and faster transition groups, respectively.
Across both cross-titration groups, treatment with Cobenfy was generally well tolerated, with no new safety or tolerability issues emerging. In the trial, 49% of patients had ≥1 treatment-emergent adverse event (TEAE) and none were serious. TEAE rates were consistent with those reported in the EMERGENT trials. In the slower and faster transition groups, 1 (1.9%) patient and 2 (3.8%) patients, respectively, discontinued treatment early due to TEAEs.
“Cobenfy represents a fundamentally different approach to treating schizophrenia as the first novel mechanism in decades, and physicians are naturally curious as to how they can switch and transition adult patients with schizophrenia to this innovative medication,” said Harald Hampel, MD, PhD, senior vice president, worldwide head of neuroscience, global medical affairs, at Bristol Myers Squibb. “We carefully designed this trial with the scientific rigor and curiosity in mind, knowing that treatment decisions are not made lightly, and patient benefit, safety and stability is our ultimate goal.”
About Schizophrenia
Schizophrenia is a persistent and often disabling mental illness impacting how a person thinks, feels and behaves. There are three symptom domains of schizophrenia, which include positive symptoms (e.g., hallucinations, delusions, disordered thinking and speech), negative symptoms (e.g., lack of motivation, lack of emotional expression/flat affect, social withdrawal) and cognitive dysfunction (e.g., impaired attention, deficits in memory, concentration and decision-making). The symptoms of schizophrenia can affect all areas of people’s lives, making it difficult to maintain employment, live independently, and manage relationships. Schizophrenia affects nearly 24 million people worldwide, including 2.8 million people in the United States, and is one of the top 15 leading causes of disability worldwide.
About Cobenfy™ (xanomeline and trospium chloride)
Cobenfy™ (xanomeline and trospium chloride), formerly KarXT, is an oral medication for the treatment of schizophrenia in adults. Cobenfy combines xanomeline, a dual M1- and M4-preferring muscarinic receptor agonist, with trospium chloride, a muscarinic receptor antagonist that does not appreciably cross the blood-brain barrier, primarily confining its effects on peripheral tissues. While the exact mechanism of action of Cobenfy is unknown, its efficacy is thought to be due to the agonist activity of xanomeline at M1 and M4 muscarinic acetylcholine receptors in the central nervous system.
INDICATION
COBENFY™ (xanomeline and trospium chloride) is indicated for the treatment of schizophrenia in adults.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
COBENFY is contraindicated in patients with:
urinary retention
moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment
gastric retention
history of hypersensitivity to COBENFY or trospium chloride. Angioedema has been reported with COBENFY and trospium chloride.
untreated narrow-angle glaucoma
WARNINGS AND PRECAUTIONS
Risk of Urinary Retention: COBENFY can cause urinary retention. Geriatric patients and patients with clinically significant bladder outlet obstruction and incomplete bladder emptying (e.g., patients with benign prostatic hyperplasia (BPH), diabetic cystopathy) may be at increased risk of urinary retention.
COBENFY is contraindicated in patients with pre-existing urinary retention and is not recommended in patients with moderate or severe renal impairment.
In patients taking COBENFY, monitor for symptoms of urinary retention, including urinary hesitancy, weak stream, incomplete bladder emptying, and dysuria. Instruct patients to be aware of the risk and promptly report symptoms of urinary retention to their healthcare provider. Urinary retention is a known risk factor for urinary tract infections. In patients with symptoms of urinary retention, consider reducing the dose of COBENFY, discontinuing COBENFY, or referring patients for urologic evaluation as clinically indicated.
Risk of Use in Patients with Hepatic Impairment: Patients with hepatic impairment have higher systemic exposures of xanomeline, a component of COBENFY, compared to patients with normal hepatic function, which may result in increased incidence of COBENFY-related adverse reactions.
COBENFY is contraindicated in patients with moderate or severe hepatic impairment. COBENFY is not recommended in patients with mild hepatic impairment.
Assess liver enzymes prior to initiating COBENFY and as clinically indicated during treatment.
Risk of Use in Patients with Biliary Disease: In clinical studies with COBENFY, transient increases in liver enzymes with rapid decline occurred, consistent with transient biliary obstruction due to biliary contraction and possible gallstone passage.
COBENFY is not recommended for patients with active biliary disease such as symptomatic gallstones. Assess liver enzymes and bilirubin prior to initiating COBENFY and as clinically indicated during treatment. The occurrence of symptoms such as dyspepsia, nausea, vomiting, or upper abdominal pain should prompt assessment for gallbladder disorders, biliary disorders, and pancreatitis, as clinically indicated.
Discontinue COBENFY in the presence of signs or symptoms of substantial liver injury such as jaundice, pruritus, or alanine aminotransferase levels more than five times the upper limit of normal or five times baseline values.
Decreased Gastrointestinal Motility: COBENFY contains trospium chloride. Trospium chloride, like other antimuscarinic agents, may decrease gastrointestinal motility. Administer COBENFY with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention. Use COBENFY with caution in patients with conditions such as ulcerative colitis, intestinal atony, and myasthenia gravis.
Risk of Angioedema: Angioedema of the face, lips, tongue, and/or larynx has been reported with COBENFY and trospium chloride, a component of COBENFY. In one case, angioedema occurred after the first dose of trospium chloride. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, discontinue COBENFY and initiate appropriate therapy and/or measures necessary to ensure a patent airway. COBENFY is contraindicated in patients with a history of hypersensitivity to trospium chloride.
Risk of Use in Patients with Narrow-angle Glaucoma: Pupillary dilation may occur due to the anticholinergic effects of COBENFY. This may trigger an acute angle closure attack in patients with anatomically narrow angles. In patients known to have anatomically narrow angles, COBENFY should only be used if the potential benefits outweigh the risks and with careful monitoring.
Increases in Heart Rate: COBENFY can increase heart rate. Assess heart rate at baseline and as clinically indicated during treatment with COBENFY.
Anticholinergic Adverse Reactions in Patients with Renal Impairment: Trospium chloride, a component of COBENFY, is substantially excreted by the kidney. COBENFY is not recommended in patients with moderate or severe renal impairment (estimated glomerular filtration rate (eGFR)
US Market News
3月前
Bristol Myers Squibb Reinforces Leadership in oHCM with New Camzyos (mavacamten) Data at American College of Cardiology Annual Scientific Session & Expo 2026 (ACC.26)March 23, 2026 6:59 AM
Business Wire
Positive Phase 3 results of SCOUT-HCM trial highlight potential of Camzyos to be the first cardiac myosin inhibitor for the treatment of adolescents with symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
New real-world evidence further reinforces the long-term, consistent efficacy and safety profile of Camzyos across diverse patient populations in oHCM
Bristol Myers Squibb (NYSE: BMY) today announced the presentation of new clinical trial and real-world data for Camzyos (mavacamten) at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo, taking place March 28–30, 2026, in New Orleans, Louisiana. Presentations at ACC will build upon the most comprehensive and mature evidence base in symptomatic obstructive hypertrophic cardiomyopathy (oHCM), further establishing Camzyos as a paradigm-shifting therapy across a range of patient populations. New data include multiple real-world data analyses demonstrating the consistent effectiveness and safety profile of Camzyos in adults, as well as full results from SCOUT-HCM, the first Phase 3 clinical trial evaluating a cardiac myosin inhibitor (CMI) as a potential treatment for adolescents with oHCM.
“Camzyos has redefined the standard of care for oHCM treatment in adults, which is further supported by the long-term and real-world data being presented during the meeting,” said Cristian Massacesi, MD, executive vice president, Chief Medical Officer and Head of Development, Bristol Myers Squibb. “We also look forward to presenting data from the SCOUT-HCM study that supports the potential of Camzyos in adolescents with oHCM, a patient population whose current treatment options are limited to symptom management.”
Key presentations at ACC 2026 include:
A late-breaking oral presentation of results from SCOUT-HCM, a Phase 3 randomized, double-blind, placebo-controlled international trial, which found Camzyos achieved its primary endpoint and several secondary endpoints around its efficacy and safety profile in adolescent patients with symptomatic oHCM.
A moderated poster presentation from DISCOVER-HCM, an ongoing observational, multicenter, retrospective and prospective study of patients with symptomatic oHCM in the U.S. and Puerto Rico evaluating the real-world safety and effectiveness profile of Camzyos, with results consistent with those seen in clinical trials.
New data from MARVEL-HCM provide real-world insight into Camzyos use among patients with symptomatic oHCM in the U.S. These findings describe the consistent and sustained effectiveness and safety profile of Camzyos in the real-world setting, while underscoring the importance of systematically assessing for obstructive physiology—including with provocation—to accurately characterize HCM subtype, improve disease recognition, and align patients with guideline-recommended treatment strategies.
Real-world outcomes from COMPASS-HCM, a prospective, observational study of patients with symptomatic oHCM in the U.S., highlighting the positive impact of Camzyos treatment on patient-reported quality of life and health status changes in as early as two weeks of treatment. These findings spotlight the meaningfulness of improvement in patient-reported outcome (PRO) measures to patients, also captured in their own words.
Select abstracts sponsored by Bristol Myers Squibb to be presented at ACC.26 can be found below. Complete abstracts can be accessed online here. Learn more about Bristol Myers Squibb’s scientific approach to and resources on cardiovascular diseases on BMS.com.
Abstract Title
Primary Author
Type
Session Title
Date/Time (CDT)
The real-world safety and effectiveness of mavacamten for obstructive hypertrophic cardiomyopathy: Insights from the US sites of DISCOVER-HCM registry
Januzzi, J.
Moderated Poster
Evolving Forces: Modern Therapies and Phenotypes in Hypertrophic Cardiomyopathy
Saturday, March 28
9:42 AM-9:49 AM
Mavacamten demonstrates clinical and hemodynamic benefits in symptomatic obstructive hypertrophic cardiomyopathy with only provocable outflow gradients: Real-world experience from MARVEL-HCM
Alsidawi, S.
Moderated Poster
Translating Myosin Inhibition into Functional Recovery in Hypertrophic Cardiomyopathy
Saturday, March 28
9:42 AM-9:49 AM
Rapid improvement in patient-reported health status during initiation of mavacamten therapy for symptomatic, obstructive hypertrophic cardiomyopathy: Interim results of the COMPASS-HCM study
Wang, A.
Moderated Poster
Translating Myosin Inhibition into Functional Recovery in Hypertrophic Cardiomyopathy
Saturday, March 28
9:54 AM-10:01 AM
Real-world patient-perceived meaningfulness of change in obstructive hypertrophic cardiomyopathy: A qualitative interview study
Zhong, Y.
Poster
Heart Failure and Cardiomyopathies 02?
Saturday, March 28 11:00 AM-12:00 PM
Effectiveness and safety of mavacamten in a cohort with high background prevalence of atrial fibrillation: Real-world experience from MARVEL-HCM
Harper, M.
Poster
Heart Failure and Cardiomyopathies 04
Saturday, March 28 2:00 PM-3:00 PM
Mavacamten in symptomatic adolescent patients with obstructive hypertrophic cardiomyopathy: Results from the Phase 3 SCOUT-HCM trial
Rossano, J.
Oral Presentation
Late-Breaking Clinical Trials IV?
Sunday, March 29
11:30 AM-11:40 AM
Real-world evidence from the MARVEL-HCM multicenter study of mavacamten — a sex-based analysis of baseline characteristics and cardiac structural and functional changes
Martinez, M.W.
Moderated Poster
Comparative Efficacy, Sex Differences and Evolving Evidence of Cardiac Myosin Inhibitors in HCM
Monday, March 30 11:00 AM-11:07 AM
About CAMZYOS® (mavacamten)
CAMZYOS® (mavacamten) is the most extensively studied cardiac myosin inhibitor (CMI), approved by regulatory bodies in more than 60 countries and regions across five continents worldwide. In the U.S., CAMZYOS is indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. In the European Union, CAMZYOS is indicated for the treatment of symptomatic (NYHA, class II-III) oHCM in adult patients.
A selective, reversible, allosteric inhibitor of cardiac myosin, CAMZYOS targets hypercontractility, the source of oHCM. Reduction in cardiac contractility with CAMZYOS treatment leads to reduced LVOT obstruction, improved energy consumption, and lower cardiac filling pressures in oHCM patients. These effects translate to improvements in symptoms for patients with symptomatic oHCM, enabling them to be more active in their daily lives. CAMZYOS can be used with or without background therapies, including for newly diagnosed patients.
CAMZYOS is supported by the largest body of worldwide evidence in the CMI treatment class, with up to five years of follow up across multiple long-term evidence and real-world studies, demonstrating the consistent and sustained benefits of CAMZYOS to improve symptoms and impact cardiac structure. CAMZYOS has been prescribed by more than 4,500 healthcare providers (HCPs) to more than 22,000 patients in the U.S. alone.
Bristol Myers Squibb: Changing the Course of Cardiovascular Disease
Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. Cardiovascular disease is the leading cause of death worldwide, and despite major advances in how we prevent and treat it, the human and societal burden continues to worsen each year. Whether a cardiovascular disease that affects millions of people around the world, or a rarer condition, the need is the same: new and better treatment options that allow people to continue to live their fullest lives.
Bristol Myers Squibb is committed to developing new treatments to address the global burden of cardiovascular disease. Building on our 70-year legacy of discovering and delivering paradigm-changing cardiovascular medicines, we are leveraging our experience and expertise to take cardiovascular research to the next level and deliver meaningful, life-changing outcomes for patients.
CAMZYOS U.S. IMPORTANT SAFETY INFORMATION
WARNING: RISK OF HEART FAILURE
CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.
Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Initiation of CAMZYOS in patients with LVEF
US Market News
4月前
Bristol Myers Squibb Announces Positive Phase 3 Results from the SUCCESSOR-2 Study of Oral Mezigdomide in Relapsed or Refractory Multiple MyelomaMarch 9, 2026 6:59 AM
Business Wire
Study marks the first positive Phase 3 study for mezigdomide and the second positive Phase 3 study for the Bristol Myers Squibb CELMoD program
Bristol Myers Squibb (NYSE: BMY) today announced positive interim Phase 3 results from the SUCCESSOR-2 study (NCT05552976). In the trial, oral mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus carfilzomib and dexamethasone alone (Kd) in patients with relapsed or refractory multiple myeloma (RRMM). Safety findings were consistent with the known profile of mezigdomide and the combination regimen. Patients will continue to be followed for survival and safety.
“We are excited by these results, which underscore Bristol Myers Squibb’s leadership in treating multiple myeloma and our unwavering commitment to patients living with this persistent and challenging disease,” said Cristian Massacesi, executive vice president, chief medical officer and head of development at Bristol Myers Squibb. “Importantly, these findings reinforce the value of our CELMoD program and our targeted protein degradation platform, and strengthen our confidence in bringing forward effective, accessible oral treatment options for patients with difficult-to-treat blood cancers and potentially beyond.”
“While treatment advances have been meaningful, far too many patients with multiple myeloma still relapse or stop responding—making the need for new options urgent,” said Paul Richardson, MD, Director of Clinical Research and Clinical Program Leader at the Jerome Lipper Multiple Myeloma Center, the Dana-Farber Cancer Institute and RJ Corman Professor of Medicine, Harvard Medical School. “These data underscore the potential of MeziKd as an oral regimen that could address a key unmet need for patients previously exposed to anti-CD38 and lenalidomide.”
“It is important for patients to have treatment options that offer enduring disease control,” said Meletios-A. (Thanos) Dimopoulos, MD, Professor and Chairman, Department of Clinical Therapeutics at Alexandra Hospital, School of Medicine, National and Kapodistrian University of Athens. “These positive interim data show that adding mezigdomide, a CELMoD specifically optimized for enhanced myeloma cell killing and immune activation compared with IMiD agents, to carfilzomib and dexamethasone may provide clinical benefit in earlier relapse.”
Data from SUCCESSOR-2 will be presented at a future medical meeting and results will be shared with health authorities.
About SUCCESSOR-2
SUCCESSOR-2 (NCT05552976) is an inferential, seamless Phase 2/3, multicenter, randomized, open-label study evaluating the efficacy and safety of mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) versus carfilzomib and dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma (RRMM).
The primary endpoint of the Phase 3 portion is progression-free survival (PFS). Key secondary endpoints include overall survival (OS), overall response rate (ORR), duration of response (DoR), time to progression (TTP), time to next treatment (TTNT), minimal residual disease (MRD) negativity, and health-related quality of life (HR-QoL).
About Targeted Protein Degradation and Novel CELMoD Agents
Targeted protein degradation (TPD) is a differentiated research platform at Bristol Myers Squibb built on more than two decades of scientific expertise, providing new avenues to degrade therapeutically relevant proteins that were previously considered "undruggable.” BMS is the only company that has successfully developed and commercialized protein degrader agents for the treatment of multiple myeloma. These agents, known as immunomodulatory drugs (IMiDs), helped establish the current standard of care in the treatment of this disease, which remains without a cure. BMS is building on this foundation with several investigational protein degraders in clinical trials, leveraging three different modalities including CELMoD agents, ligand-directed degraders (LDDs), and degrader antibody conjugates (DACs). This three-pronged approach enables matching the right therapeutic modality to a molecular mechanism of action to modulate targets most effectively and ultimately provide more opportunities for potential breakthroughs that may offer meaningful new options for patients across a broad range of diseases, in and beyond hematology and oncology. Learn more about the science behind TPD at Bristol Myers Squibb here.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, and that mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) may not receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such combination treatment for such indication will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2024, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
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View source version on businesswire.com: https://www.businesswire.com/news/home/20260308945507/en/
Bristol Myers Squibb
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Investors:
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Original: Bristol Myers Squibb Announces Positive Phase 3 Results from the SUCCESSOR-2 Study of Oral Mezigdomide in Relapsed or Refractory Multiple Myeloma
US Market News
4月前
U.S. Food and Drug Administration Accepts Bristol Myers Squibb's New Drug Application for Iberdomide in Patients with Relapsed or Refractory Multiple MyelomaFebruary 17, 2026 6:59 AM
Business Wire
Iberdomide has the potential to be the first approved CELMoD agent
The U.S. FDA has granted Breakthrough Therapy Designation and Priority Review for this indication and assigned a target action date of August 17, 2026
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for iberdomide combined with standard treatment (daratumumab + dexamethasone - IberDd) in patients with relapsed or refractory multiple myeloma (RRMM). Iberdomide is part of an investigational, new class of medicines called cereblon E3 ligase modulator (CELMoD) agents. The FDA has granted a Prescription Drug User Fee Act (PDUFA) date of August 17, 2026 for this indication.
“The FDA’s acceptance of this application is a testament to the potential of iberdomide, in combination with anti-CD38 monoclonal antibodies, as a novel, potent, oral treatment option, with a manageable safety profile, for patients with multiple myeloma,” said Cristian Massacesi, executive vice president and chief medical officer, Bristol Myers Squibb. “Furthermore, our filing for iberdomide based on the MRD endpoint, underscores our commitment to pioneering new ways of advancing life-saving therapies for patients living with cancer.”
The filing was based on results from a planned analysis of MRD negativity rates in the Phase 3 EXCALIBER-RRMM study evaluating iberdomide as a treatment for RRMM patients. The EXCALIBER-RRMM trial is ongoing and patients continue to be evaluated for progression-free survival (PFS).
The FDA also granted Breakthrough Therapy designation for iberdomide based on these data.
This review is being conducted under the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in several other countries.
Bristol Myers Squibb thanks the patients and investigators involved with the Phase 3 EXCALIBER study.
About EXCALIBER-RRMM
EXCALIBER-RRMM (NCT04975997) is a Phase 3, multicenter, two-stage, randomized, open-label study evaluating the efficacy and safety of iberdomide in combination with daratumumab and dexamethasone (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma (RRMM). The study is designed to assess dual-primary endpoints of minimal residual disease (MRD) negativity and progression-free survival (PFS), with additional secondary endpoints including overall survival (OS), overall response rate (ORR), duration of response (DoR), time to progression (TTP), time to next treatment (TTNT), and health-related quality of life (HR-QoL). Stage 1 of the study identified 1.0 mg iberdomide as the optimal dose based on safety, pharmacokinetics, and efficacy data. In Stage 2, approximately 664 patients were randomized to receive either IberDd or DVd.
About Minimal Residual Disease (MRD)
Minimal residual disease (MRD) refers to the small number of cancer cells that may remain in a patient’s body after treatment and are undetectable using conventional diagnostic methods. In multiple myeloma, MRD assessment has emerged as a highly sensitive and clinically meaningful tool for evaluating treatment response. MRD negativity does not necessarily mean all cancer cells are gone, but it may predict improved clinical outcomes, including longer remission and survival.
Modern MRD detection methods, such as next-generation sequencing (NGS) and next-generation flow cytometry (NGF), can identify one malignant cell among 100,000 (threshold for MRD) to 1,000,000 normal cells, offering unprecedented precision in measuring disease burden. MRD is increasingly being used in clinical trials as a surrogate endpoint for progression-free survival (PFS) and is gaining recognition from regulatory authorities for its role in accelerating therapeutic development.
About Targeted Protein Degradation and Novel CELMoD Agents
Targeted protein degradation (TPD) is a differentiated research platform at Bristol Myers Squibb built on more than two decades of scientific expertise, providing new avenues to degrade therapeutically relevant proteins that were previously considered "undruggable.” BMS is the only company that has successfully developed and commercialized protein degrader agents for the treatment of multiple myeloma. These agents, known as immunomodulatory drugs (IMiDs), helped establish the current standard of care in the treatment of this disease, which remains without a cure. BMS is building on this foundation with several investigational protein degraders in clinical trials, leveraging three different modalities including CELMoD agents, ligand-directed degraders (LDDs), and degrader antibody conjugates (DACs). This three-pronged approach enables matching the right therapeutic modality to a molecular mechanism of action to modulate targets most effectively and ultimately provide more opportunities for potential breakthroughs that may offer meaningful new options for patients across a broad range of diseases, in and beyond hematology and oncology. Learn more about the science behind TPD at Bristol Myers Squibb here.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that iberdomide in combination with standard therapies may not achieve its primary study endpoints or receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such combination treatment for such indication will be commercially successful. No forward-looking statement can be guaranteed. It should also be noted that Breakthrough Therapy Designation does not change the standards for FDA approval. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
corporatefinancial-news
View source version on businesswire.com: https://www.businesswire.com/news/home/20260217657186/en/
Bristol Myers Squibb
Media inquiries:
media@bms.com
Investors relations:
investor.relations@bms.com
Original: U.S. Food and Drug Administration Accepts Bristol Myers Squibb's New Drug Application for Iberdomide in Patients with Relapsed or Refractory Multiple Myeloma
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