Welcome to our dedicated page for Bristol-Myers Squibb Co news (Ticker: BMY), a resource for investors and traders seeking the latest updates and insights on Bristol-Myers Squibb Co stock.
Bristol-Myers Squibb news coverage encompasses regulatory developments, clinical trial results, product launches, business transactions, and corporate initiatives. The company's activities across oncology, hematology, immunology, cardiovascular, and neuroscience generate frequent updates that impact stakeholders in the healthcare and investment communities.
Regulatory announcements represent significant news events for Bristol-Myers Squibb, including approvals of new medicines, expanded indications for existing products, and regulatory submissions in various markets. These milestones reflect the progression of the company's pipeline from clinical development through regulatory review to market authorization. Priority review designations, breakthrough therapy designations, and orphan drug designations also generate news coverage as indicators of regulatory progress.
Clinical trial data releases occur at medical conferences, in peer-reviewed publications, and through corporate announcements. Results from pivotal trials evaluating new medicines or expanded uses of approved products receive particular attention from the medical community and investors. The company's extensive clinical trial portfolio across multiple therapeutic areas produces a steady stream of data readouts that inform understanding of product profiles and market potential.
Business development activities including acquisitions, licensing agreements, research collaborations, and strategic partnerships shape Bristol-Myers Squibb's long-term direction. These transactions can bring new assets into the pipeline, provide access to novel technologies, or establish collaborations with academic institutions and biotechnology companies. Divestitures and portfolio prioritization decisions also generate news coverage.
Commercial performance updates occur through periodic financial reporting and corporate presentations. These updates provide insight into product uptake, market penetration, competitive dynamics, and the impact of healthcare policy changes on business results. Manufacturing capacity expansions, supply chain developments, and commercial launches in new geographic markets represent additional categories of business news.
Corporate initiatives related to sustainability, patient access, health equity, research funding, and community engagement reflect broader aspects of Bristol-Myers Squibb's operations beyond drug development and commercialization. Leadership changes, organizational restructuring, and strategic priority shifts also contribute to news flow.
Bristol Myers Squibb (NYSE: BMY) announced that the FDA has accepted for priority review the supplemental Biologics License Application for Reblozyl (luspatercept-aamt) to treat anemia in adults with non-transfusion dependent beta thalassemia, with a PDUFA goal date of March 27, 2022. The application is based on Phase 2 BEYOND study results. Additionally, the European Medicines Agency has validated the Type II variation for Reblozyl in this indication. The BEYOND study involved 145 patients, aimed at assessing efficacy and safety.
Bristol Myers Squibb (NYSE: BMY) announced the acceptance of its New Drug Application (NDA) for deucravacitinib, an oral selective tyrosine kinase 2 (TYK2) inhibitor, by the
Bristol Myers Squibb (NYSE:BMY) has received European Commission approval for Zeposia (ozanimod) as a treatment for adults with moderately to severely active ulcerative colitis (UC). This marks Zeposia as the first oral S1P receptor modulator for UC, providing a new treatment option for patients unresponsive to conventional therapies. The approval is based on the Phase 3 True North trial, demonstrating significant clinical benefits, including increased remission rates and no new safety concerns.
Bristol Myers Squibb (NYSE: BMY) announced that the FDA has extended the review of its New Drug Application for mavacamten, intended for treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM), to April 28, 2022. This extension, notified on November 18, 2021, allows more time for assessing the updated Risk Evaluation Mitigation Strategy. No additional data or studies are required. The company maintains confidence in mavacamten's profile, citing positive results in the pivotal EXPLORER-HCM trial, which highlighted improvements in symptoms and quality of life for patients.
Bristol Myers Squibb (NYSE:BMY) has awarded five biotech startups with the 2021 Golden Ticket, granting them a year of lab space and support to foster innovation. The winners include RADD Pharmaceuticals, Rubik Therapeutics, Waypoint Bio, Altay Therapeutics, and VastBiome, each selected to advance research in various therapeutic fields. This initiative aims to stimulate the growth of life science startups and enhance collaborations within scientific communities, aligning with BMY's commitment to developing new medicines for serious diseases.
Bristol Myers Squibb (NYSE:BMY) announced positive results from the Phase 2 AXIOMATIC-TKR study, showcasing that the investigational oral agent milvexian effectively reduces venous thromboembolism (VTE) risk post-total knee replacement without increasing bleeding risks compared to enoxaparin. No major bleeding events occurred in the milvexian cohort. The trial demonstrated a significant dose-response relationship, with milvexian reducing VTE rates to 12% versus a benchmark of 30%. These findings support further exploration of milvexian's therapeutic potential.
Bristol Myers Squibb has launched the Could It Be HCM? campaign to raise awareness about hypertrophic cardiomyopathy (HCM), a chronic heart condition affecting 1 in 200 to 1 in 500 people. The campaign aims to educate the public about symptoms and encourage discussions with healthcare providers. Notably, an estimated 85% of HCM cases remain undiagnosed in the U.S. Professional basketball player Jared Butler, who has HCM, will share his experience to promote the campaign. The initiative includes resources found at CouldItBeHCM.com.
Bristol Myers Squibb (NYSE: BMY) announced its participation in the Wolfe Research Virtual Healthcare Conference, set for November 17, 2021, at 8:45 a.m. EST. CEO Giovanni Caforio will engage in a fireside chat, addressing company-related questions. Investors and the public can listen to the live webcast through the company’s investor relations website, with a recorded edition available later the same day. This event highlights BMY’s commitment to transparency and investor engagement.
Bristol Myers Squibb (NYSE: BMY) presented comprehensive research on its cardiovascular portfolio at the American Heart Association's annual Scientific Sessions from November 13-15, 2021. Key presentations included results from the AXIOMATIC-TKR study, exploring milvexian's efficacy in total knee replacement surgery, and analyses on mavacamten for obstructive hypertrophic cardiomyopathy. Researchers emphasized commitment to advancing treatment options for cardiovascular disease, a leading global health issue.
Bristol Myers Squibb (NYSE: BMY) announced that its Phase 3 CheckMate -816 trial successfully met the primary endpoint of improved event-free survival (EFS) in patients with resectable stage IB to IIIA non-small cell lung cancer (NSCLC). The combination of Opdivo (nivolumab) and chemotherapy showed significant EFS benefits compared to chemotherapy alone in a prespecified interim analysis. This is the first Phase 3 trial with an immunotherapy-based combination to demonstrate substantial efficacy in a neoadjuvant setting, marking a pivotal advancement in the treatment of NSCLC.
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