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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.
Track critical updates through curated press releases covering drug development milestones, financial earnings reports, and research collaborations. Our aggregation ensures you never miss regulatory filings, product launch announcements, or patent developments impacting BMY's market position.
Discover timely information on therapeutic advancements in immuno-oncology and hematology, plus insights into global healthcare trends affecting pharmaceutical operations. Bookmark this page for streamlined monitoring of BMY's scientific innovations and corporate announcements essential for informed analysis.
Bristol Myers Squibb (NYSE:BMY) presented results from COLLIGO-HCM, a global real-world study of Camzyos (mavacamten) at the ESC Congress 2025. The study demonstrated the drug's effectiveness in treating obstructive hypertrophic cardiomyopathy (oHCM) across a diverse patient population from four continents.
Key findings showed that 59.9% of patients achieved NYHA class improvement by week 24, with 94.4% of patients reaching NYHA class II or below at 24 weeks. By week 36, 90.3% of patients achieved target LVOT gradients. The safety profile remained consistent with clinical trials, with only 4% requiring temporary interruption due to LVEF concerns.
The study is part of the larger WAYFARER-HCM program, spanning 7 countries and over 3,000 patients, reinforcing Camzyos' position as a standard of care for NYHA class II-III symptomatic oHCM patients.
Bristol Myers Squibb (NYSE: BMY) announced its participation in the Morgan Stanley 23rd Annual Global Healthcare Conference scheduled for September 8, 2025. The company will engage in a fireside chat starting at 8:30 a.m. ET.
The session will be accessible to investors and the public through the company's investor relations website at investor.bms.com, with an archived recording available after the event.
Bristol Myers Squibb (NYSE: BMY) announced new clinical and real-world data presentations for its cardiovascular portfolio at the upcoming European Society of Cardiology Congress 2025 in Madrid. The presentations will focus on Camzyos (mavacamten), the first and only approved cardiac myosin inhibitor for symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
Key highlights include real-world outcomes from COLLIGO-HCM study across five countries, a pooled analysis of four Phase 3 studies on Camzyos monotherapy, and topline results from ODYSSEY-HCM, the largest Phase 3 trial in non-obstructive HCM patients. The congress will take place from August 29 to September 1, 2025, featuring multiple presentations on Camzyos's efficacy, safety, and real-world effectiveness.
Bristol Myers Squibb (NYSE: BMY) and SystImmune announced that their drug izalontamab brengitecan (iza-bren) has received Breakthrough Therapy Designation (BTD) from the FDA for treating advanced EGFR-mutated non-small cell lung cancer (NSCLC) in patients who progressed after EGFR TKI and platinum-based chemotherapy.
Iza-bren is a first-in-class bispecific antibody-drug conjugate (ADC) targeting both EGFR and HER3 receptors. The BTD was based on promising efficacy and safety data from three ongoing clinical trials: BL-B01D1-101, BL-B01D1-203 (in China), and the global BL-B01D1-LUNG-101 study.
This development addresses a significant unmet need, as NSCLC represents 80% of lung cancer cases, with 10-15% of Western and up to 50% of Asian patients having EGFR mutations. Current treatments typically show resistance after 18 months, highlighting the need for more effective therapies.
Bristol Myers Squibb (NYSE: BMY) announced that the FDA has accepted their supplemental biologics license application (sBLA) for Breyanzi with Priority Review for treating adult patients with relapsed or refractory marginal zone lymphoma (MZL). The PDUFA goal date is set for December 5, 2025.
The application is based on results from the MZL cohort in TRANSCEND FL, a Phase 2 study presented at ICML 2025. If approved, Breyanzi would become the first and only CAR T cell therapy for MZL, addressing a significant unmet need in patients who have received at least two prior lines of systemic therapy.
This potential approval would mark Breyanzi's fifth cancer type indication, building on its existing approvals in LBCL, CLL/SLL, follicular lymphoma, and mantle cell lymphoma.
Bristol Myers Squibb (NYSE: BMY) has announced its second quarter 2025 financial results. The company will host a conference call and audio webcast for analysts and investors on July 31, 2025, at 8:00 a.m. ET to discuss the quarterly performance.
The detailed earnings release and investor presentation are available on the company's Investor Relations website. A replay of the webcast will be accessible approximately three hours after the conference call concludes.
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.
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