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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) 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.
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.
Bristol Myers Squibb (BMY) has received a positive recommendation from the European Medicines Agency's CHMP for the approval of Opdivo (nivolumab) combined with chemotherapy as a first-line treatment for adults with HER2-negative advanced gastric or esophageal cancers with PD-L1 expression (CPS ≥ 5). This follows favorable results from the Phase 3 CheckMate -649 trial, demonstrating significant improvements in overall and progression-free survival compared to chemotherapy alone. The recommendation awaits final approval from the European Commission.
Bristol Myers Squibb announced significant long-term results from the Phase 3 CheckMate -214 trial, revealing a five-year survival rate of 48% for patients with advanced renal cell carcinoma treated with the Opdivo (nivolumab) and Yervoy (ipilimumab) combination. The data showed a median overall survival (OS) of 55.7 months for the combination therapy versus 38.4 months for sunitinib. The study continues to demonstrate durable responses, with ongoing improvements in overall response rates (ORR) and no new safety signals emerging over extended follow-up.
