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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 has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for Breyanzi, aimed at treating adult patients with diffuse large B-cell lymphoma and related conditions who relapse within 12 months after first-line therapy. This endorsement is based on the pivotal Phase 3 TRANSFORM study results, which showcased Breyanzi's efficacy as a second-line treatment compared to conventional methods. The European Commission's final decision is expected within two months. This milestone underscores a new potential standard of care in a critical unmet need for many patients.
Bristol Myers Squibb (BMY) reported three-year follow-up results from the Phase 3 CheckMate -816 trial at ELCC 2023, highlighting significant clinical benefits of neoadjuvant Opdivo (nivolumab) combined with chemotherapy in non-small cell lung cancer (NSCLC). The combination therapy reduced the risk of disease recurrence, progression, or death by 32%, achieving a 57% event-free survival (EFS) rate compared to 43% with chemotherapy alone. Time to distant metastasis or death was also improved, with rates of 71% vs. 50%. Although overall survival data remains immature, a favorable trend was observed, with 78% of patients alive at three years versus 64% with chemotherapy.
Bristol Myers Squibb (NYSE:BMY) announced the European Commission's approval of Sotyktu (deucravacitinib), a first-in-class oral therapy for moderate-to-severe plaque psoriasis. The approval is based on pivotal Phase 3 trials (POETYK PSO-1 and POETYK PSO-2), which demonstrated Sotyktu's superior efficacy over both placebo and Otezla at 16 and 24 weeks, with sustained responses at 52 weeks. Notably, the therapy presents a favorable safety profile. With approximately 14 million people affected by psoriasis in Europe, Sotyktu addresses an urgent need for accessible and effective treatments in this patient population.
CHARM Therapeutics has announced a strategic collaboration with Bristol Myers Squibb (BMY) to utilize its DragonFold deep learning platform for discovering and optimizing compounds against selected targets. CHARM will lead early discovery efforts, while BMY retains the option to license developed compounds. The agreement includes an upfront payment and potential future payments, which enhance CHARM's financial runway. This collaboration aims to accelerate the development of new medicines addressing difficult-to-target diseases, reinforcing BMY's commitment to innovative treatments.
Bristol Myers Squibb (NYSE: BMY) will report its first quarter 2023 financial results on
Bristol Myers Squibb (NYSE: BMY) has declared a quarterly dividend of $0.57 per share on its common stock, payable on May 1, 2023, to shareholders of record by April 10, 2023. Additionally, a dividend of $0.50 per share on its $2.00 convertible preferred stock is set for June 1, 2023, payable to stockholders by May 2, 2023. This reflects the company's commitment to returning value to its shareholders while pursuing its mission to develop innovative medicines for serious diseases.
Viz.ai has entered into a multi-year partnership with Bristol Myers Squibb (BMY) to implement an AI algorithm designed to detect and triage patients for hypertrophic cardiomyopathy (HCM). The AI algorithm, which is under FDA review following a de novo classification request, aims to streamline the identification process for patients who may be at risk. HCM affects millions globally, and timely diagnosis can significantly improve outcomes. The collaboration will enhance capabilities within the Viz.ai Cardio Suite, which is currently utilized by around 1,300 U.S. hospitals.
Bristol Myers Squibb (NYSE: BMY) has received full Marketing Authorization from the European Commission for Reblozyl (luspatercept), enabling its use in treating adult patients with non-transfusion-dependent beta thalassemia-associated anemia. This marks Reblozyl's third approval in Europe, complementing existing uses for transfusion-dependent beta thalassemia and myelodysplastic syndromes. The approval is based on the Phase 2 BEYOND study, where 77.1% of patients on Reblozyl achieved significant hemoglobin improvements. The drug is developed in collaboration with Merck following its acquisition of Acceleron Pharma in November 2021.
Bristol Myers Squibb (BMY) has launched the Phase 3 Librexia program, which includes three concurrent trials—Librexia STROKE, Librexia ACS, and Librexia AF—targeting nearly 50,000 patients. This program assesses milvexian, an investigational oral factor XIa inhibitor, for improving outcomes in thrombotic conditions. Enrollment in the Librexia STROKE trial has commenced, aiming to demonstrate superiority in stroke prevention alongside standard antiplatelet therapy. Strong Phase 2 data supports this initiative, showcasing milvexian's potential to enhance the benefit-risk profile in treating acute coronary syndromes and atrial fibrillation.
Bristol Myers Squibb (NYSE: BMY) will participate in a fireside chat at Cowen's 43rd Annual Health Care Conference on March 7, 2023, at 9:50 a.m. ET. Samit Hirawat, M.D., Chief Medical Officer, will address questions about the company's developments.
Investors and the public can access a live webcast of the session at investor.bms.com, with an archived version available later that day.
As a global biopharmaceutical company, Bristol Myers Squibb aims to deliver innovative medicines to help patients overcome serious diseases.