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Bristol-Myers Squibb Company (BMY) is a global biopharmaceutical leader developing innovative therapies in oncology, cardiovascular diseases, and immunology. This dedicated news hub provides investors and healthcare professionals with direct access to BMY's latest developments, including FDA approvals, clinical trial results, and strategic partnerships.
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Bristol Myers Squibb (NYSE: BMY) and Bain Capital have announced the formation of a new independent biopharmaceutical company focused on developing immunology therapies for autoimmune diseases. The new company launches with $300 million in financing led by Bain Capital and five immunology assets in-licensed from BMS.
The portfolio includes three clinical-stage and two Phase 1-ready investigational medicines, with the most advanced being afimetoran, a TLR7/8 inhibitor in Phase 2 trials for lupus, and BMS-986322, a TYK2 inhibitor that showed positive Phase 2 results in plaque psoriasis. BMS will maintain a 20% equity stake in the new company and receive royalties and milestones tied to asset success.
Daniel S. Lynch will serve as Executive Chairman and interim CEO, with representatives from both BMS and Bain Capital joining the board of directors.
Bristol Myers Squibb (NYSE: BMY) has appointed Cristian Massacesi, M.D. as Executive Vice President, Chief Medical Officer, and Head of Development, effective August 1, 2025. Dr. Massacesi, who brings over 20 years of global biopharmaceutical experience, will oversee the company's early-stage and late-stage product development across all therapeutic areas.
He joins from AstraZeneca where he served as Chief Medical Officer of AstraZeneca and Alexion, leading a global team of over 3,000 employees and securing multiple regulatory approvals. The current Executive Vice President, Samit Hirawat, M.D., will step down from his role on August 1 and depart BMS on November 1, 2025, after six years of service during which the company achieved numerous product approvals across multiple therapeutic areas.
Bristol Myers Squibb (NYSE:BMY) announced that its supplemental New Drug Application (sNDA) for Sotyktu (deucravacitinib) for treating adults with active psoriatic arthritis has been accepted for review in four global regions, including the FDA with a target action date of March 6, 2026.
The applications are supported by positive results from the POETYK PsA-1 and POETYK PsA-2 clinical trials, where Sotyktu demonstrated significantly higher ACR20 response rates compared to placebo at Week 16. The drug maintained clinical response through Week 52 in the POETYK PsA-2 trial, with a safety profile consistent with previous studies.
If approved, Sotyktu would become the first TYK2 inhibitor for psoriatic arthritis. The drug was previously approved by the FDA in 2022 for moderate-to-severe plaque psoriasis and has shown durable efficacy across over 20,000 patient-years of experience.
Bristol Myers Squibb (NYSE: BMY) announced that its Phase 3 INDEPENDENCE trial for Reblozyl® (luspatercept-aamt) did not meet its primary endpoint in treating myelofibrosis-associated anemia. Despite missing statistical significance (p=0.0674), the trial showed clinically meaningful improvements in red blood cell transfusion independence.
The study demonstrated positive secondary outcomes, including a higher number of patients achieving a 50% reduction in RBC transfusion burden and increased hemoglobin levels while maintaining transfusion independence. The safety profile remained consistent with previous findings across indications. Despite not meeting the primary endpoint, BMS plans to engage with FDA and EMA regarding potential marketing applications based on the overall positive clinical benefits observed.
Bristol Myers Squibb (NYSE:BMY) and Pfizer have announced a significant direct-to-patient program for their anticoagulant medication Eliquis® (apixaban). Starting September 8, 2025, eligible U.S. patients can purchase Eliquis directly through the Eliquis 360 Support program at a 40% discount from the current list price.
The program will provide direct shipping across all 50 states and Puerto Rico, offering simplified access and cost transparency. With over 15 million Americans prescribed Eliquis since launch, the medication has generated an estimated $3 billion in healthcare cost savings per 100,000 patients treated through reduced hospitalizations and rehabilitation needs.
Bristol Myers Squibb (NYSE: BMY) announced FDA approval of significant label updates for its CAR T cell therapies Breyanzi and Abecma. The updates include reduced patient monitoring requirements and removal of REMS programs, reflecting increased confidence in the therapies' safety profiles.
Key changes include reduction of driving restrictions from 8 to 2 weeks and requirement to stay near healthcare facilities reduced from 4 to 2 weeks post-treatment. Currently, only 2 in 10 eligible patients receive cell therapy treatment due to logistical and geographic barriers.
BMS will work with over 150 treatment centers to implement these changes and expand into community cancer centers nationwide, aiming to increase accessibility to these potentially life-saving treatments.