Welcome to our dedicated page for Bristol-Myers Squibb news (Ticker: BMY), a resource for investors and traders seeking the latest updates and insights on Bristol-Myers Squibb stock.
Bristol Myers Squibb reports news on its pharmaceutical portfolio across oncology, cardiovascular disease and immunology, including regulatory decisions, clinical trial data, commercial access programs and product collaborations. Company updates include Sotyktu (deucravacitinib), a selective TYK2 inhibitor approved in the European Union for active psoriatic arthritis, and Eliquis (apixaban), an oral anticoagulant marketed through the Bristol Myers Squibb-Pfizer alliance.
Recurring developments also cover quarterly financial results, investor conference participation, debt and capital-market activity, research collaborations in cardiovascular and precision-medicine programs, and community initiatives tied to multiple myeloma care. The company’s news flow combines product-specific regulatory milestones with broader disclosures on operating performance and pipeline partnerships.
Dr. Reddy’s Laboratories has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules in 2.5 mg and 20 mg strengths, with tentative approvals for other strengths. This positions the company to gain 180 days of generic drug exclusivity for these products. The approval follows a settlement with Celgene (Bristol Myers Squibb) regarding REVLIMID® patents, which also allows Dr. Reddy’s to market generic versions starting from January 31, 2026. This development aims to provide a more affordable option for patients.
Bristol Myers Squibb announced that the CHMP of the EMA has recommended approval for Zeposia (ozanimod) to treat adults with moderately to severely active ulcerative colitis. This recommendation is based on positive results from the Phase 3 True North study, which showed substantial improvements in multiple clinical endpoints. If approved by the European Commission, Zeposia will be the first oral S1P receptor modulator available for ulcerative colitis in the EU. The U.S. FDA previously approved Zeposia for the same condition in May 2021.
Bristol Myers Squibb (NYSE: BMY) announced promising interim results from the Phase 3 DAYBREAK trial, focusing on the long-term efficacy of Zeposia (ozanimod) for relapsing forms of multiple sclerosis (MS). Key findings revealed a low annualized relapse rate (ARR) of 0.103, with over 70% of participants relapse-free after four years. Safety profiles remained consistent with earlier studies, with no new safety signals emerging. The data emphasizes Zeposia's role in early intervention for MS patients, showcasing its potential in improving long-term outcomes.
Bristol Myers Squibb (NYSE: BMY) announced that the Phase 2 LATTICE-UC study for deucravacitinib, a selective TYK2 inhibitor for moderate to severe ulcerative colitis, failed to meet its primary endpoint of clinical remission at Week 12, as well as secondary endpoints. Despite this, the drug's safety profile remained consistent with earlier studies, showing no new safety signals. The company plans further evaluation in a second Phase 2 trial with higher doses. Notably, they maintain a revenue target of over $4 billion for deucravacitinib by 2029.
Bristol Myers Squibb (NYSE: BMY) announced an Investor Event scheduled for November 16, 2021, at 9:30 a.m. ET in New York City. Giovanni Caforio, CEO, will discuss the company’s strategy, pipeline, and business opportunities with the leadership team. This event will be webcast, allowing broader access to the discussion. Materials related to the presentation will be available at the webcast's start, and a replay will be accessible afterward. Bristol Myers Squibb is committed to developing innovative medicines for serious diseases.
Bristol Myers Squibb (BMY) has announced the validation of its Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for the LAG-3-blocking antibody relatlimab in combination with nivolumab for treating advanced melanoma. This application follows significant results from the Phase 2/3 RELATIVITY-047 trial, showing a meaningful progression-free survival benefit over standard therapy. If approved, this would be the first treatment of its kind available in the EU, positioning BMY for a critical advancement in oncology.
Bristol Myers Squibb (NYSE: BMY) has announced the validation of its Marketing Authorization Application (MAA) for mavacamten, a first-in-class cardiac myosin inhibitor aimed at treating obstructive hypertrophic cardiomyopathy (HCM). This validation by the European Medicines Agency (EMA) is based on the positive outcomes from the Phase 3 EXPLORER-HCM trial, where mavacamten significantly improved symptoms and quality of life for patients. If approved, mavacamten would be the first therapy targeting the underlying cause of obstructive HCM.
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Bristol Myers Squibb (BMY) announced that the FDA accepted supplemental Biologics License Applications for Opdivo in combination with Yervoy and chemotherapy as first-line treatments for unresectable advanced esophageal squamous cell carcinoma (ESCC). This submission is based on results from the Phase 3 CheckMate -648 trial, which showed significant overall survival benefits compared to chemotherapy. The FDA set a target action date of May 28, 2022. The company emphasizes the need for additional treatment options for the 19,000 esophageal cancer patients diagnosed annually in the U.S.
Bristol Myers Squibb (NYSE: BMY) announced the FDA's acceptance for priority review of its Biologics License Application for the fixed-dose combination of relatlimab and nivolumab, aimed at treating unresectable or metastatic melanoma in patients aged 12 and older. This combination, assessed during the Phase 2/3 RELATIVITY-047 trial, showed a significant progression-free survival benefit compared to Opdivo alone. The FDA has set a target action date of March 19, 2022. This dual immunotherapy could represent a pivotal advancement in melanoma treatment.