Bristol-Myers Squibb Co Stock Price, News & Analysis

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 U.S. Food and Drug Administration (FDA) and validation from the European Medicines Agency (EMA) for treating adults with moderate to severe plaque psoriasis. The pivotal Phase 3 POETYK-PSO trials indicate deucravacitinib's superior efficacy compared to Otezla (apremilast) and placebo. A PDUFA goal date of September 10, 2022 has been assigned by the FDA.

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.