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 (NYSE: BMY) generates frequent news across drug development, regulatory milestones, clinical data and corporate actions, reflecting its role as a global biopharmaceutical company focused on serious diseases. News coverage on this page centers on how the company’s cardiovascular, oncology, hematology, immunology and neuroscience programs progress from clinical trials to regulatory decisions and real-world use.
Recent updates have highlighted positive Phase 3 trial results for Camzyos (mavacamten) in adolescents with symptomatic obstructive hypertrophic cardiomyopathy in the SCOUT-HCM study, including statistically significant improvements in left ventricular outflow tract gradients and safety findings consistent with adult experience. Other headlines feature regulatory developments such as the U.S. Food and Drug Administration granting priority review to an Opdivo (nivolumab) plus chemotherapy combination for previously untreated advanced classical Hodgkin lymphoma, and the FDA’s approval of Breyanzi (lisocabtagene maraleucel; liso-cel) for adults with relapsed or refractory marginal zone lymphoma.
Investors and followers of BMY can also expect news on hematology research presented at major medical meetings, including data on investigational targeted protein degradation agents like golcadomide and BMS-986458, and long-term follow-up results for Breyanzi in large B-cell and follicular lymphomas. Corporate and financial items appear as well, such as dividend declarations, debt offerings, tender offers for outstanding notes, and presentations at healthcare investment conferences.
This news feed brings together company press releases, clinical trial readouts, regulatory updates, access and affordability agreements, and SEC-reported events. For users tracking BMY stock, it offers a single place to review how Bristol Myers Squibb’s pipeline, marketed products and capital markets activity evolve over time. Bookmark this page to quickly review new trial results, FDA decisions, access initiatives and financial disclosures related to Bristol Myers Squibb.
Bristol Myers Squibb (NYSE:BMY) announced a change in the timing for its fourth quarter 2020 earnings conference call. The call will now take place on Thursday, February 4, 2021, at 10 a.m. ET. Company executives will discuss the financial results and answer questions from investors. The call can be accessed via a live webcast or by phone. A replay will be available after the call ends until February 18, 2021. For additional information, materials related to the call will be available on their investor website.
Bristol Myers Squibb (NYSE: BMY) announced that the FDA has accepted its supplemental Biologics License Application for Opdivo® (nivolumab) combined with chemotherapy for patients with advanced gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma. The application received Priority Review status, with a PDUFA goal date of May 25, 2021. The filing is based on the CheckMate -649 trial, demonstrating significant improvements in overall and progression-free survival for treated patients. Opdivo's safety profile aligns with established expectations.
Bristol Myers Squibb (NYSE: BMY) announced the FDA's acceptance of its supplemental Biologics License Application for Opdivo (nivolumab) to treat resected esophageal or gastroesophageal junction cancer after neoadjuvant chemoradiation therapy. This application, which has been granted Priority Review, is expected to achieve a goal date by May 20, 2021. The filing is based on the CheckMate -577 trial, demonstrating a significant improvement in disease-free survival for patients post-surgery. Opdivo continues to show promise across various cancer types.
Bristol Myers Squibb (NYSE: BMY) has authorized an incremental share repurchase program, increasing its total to approximately $6.4 billion. The additional $2 billion in buybacks aims to enhance shareholder value, with timing and method of repurchases left to management's discretion. Share repurchases may occur through various means including open market purchases and accelerated share repurchase transactions. The company emphasizes that it is not obligated to buy back any specific amount of shares and can suspend the program at any time.
Bristol Myers Squibb (NYSE: BMY) announced its participation in the J.P. Morgan 39th Annual Virtual Healthcare Conference, scheduled for January 11, 2021, at 7:30 a.m. EST. CEO Giovanni Caforio will present and respond to questions. Investors and the public can listen to the live webcast at investor.bms.com. Materials related to the presentation will be available on the website at the start of the event, with an archived version accessible later that day.
Bristol Myers Squibb (NYSE: BMY) announced the European Medicines Agency (EMA) has validated its Type II Variation Marketing Authorization Application for Opdivo (nivolumab) in combination with chemotherapy for first-line treatment of advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma cancer. This validation, based on the Phase 3 CheckMate -649 trial results, indicates a significant improvement in overall and progression-free survival in patients expressing PD-L1. The company aims to enhance treatment options for these high-mortality cancers in the EU.
Bristol Myers Squibb (NYSE:BMY) announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application for Opdivo (nivolumab) as an adjuvant treatment for esophageal and gastroesophageal junction (GEJ) cancers in adults post-neoadjuvant chemoradiotherapy (CRT) and surgery. Validation marks the start of the EMA's centralized review process. Data from the Phase 3 CheckMate-577 trial indicated that Opdivo doubled median disease-free survival in treated patients. Opdivo is positioned as a vital treatment option for patients at high recurrence risk.
Bristol Myers Squibb (NYSE: BMY) announced that the FDA has yet to decide on the Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel) in treating relapsed or refractory large B-cell lymphoma. The lack of a decision by December 31, 2020, resulted in the termination of the Contingent Value Rights (CVR) Agreement, meaning CVRs are no longer eligible for payment and will cease trading on the NYSE. Bristol Myers Squibb is committed to collaborating with the FDA to expedite the review process.
Bristol Myers Squibb (BMY) has received validation from the European Medicines Agency (EMA) for its Marketing Authorization Application (MAA) for Zeposia (ozanimod), intended for treating adults with moderately to severely active ulcerative colitis (UC). This validation initiates the EMA’s centralized review process. The MAA is based on the True North Phase 3 trial results, which showed statistically significant outcomes in clinical remission for patients treated with Zeposia. The safety profile observed aligns with existing data.
Bristol Myers Squibb announced that CheckMate -548, a Phase 3 trial for Opdivo in newly diagnosed glioblastoma multiforme patients, will not meet its primary endpoint of overall survival. Despite limiting enrollment to patients with MGMT promoter methylation, the independent data monitoring committee confirmed the trial's disappointing outcome. No safety concerns were noted, and patients currently benefiting from Opdivo may continue treatment. The company plans to complete a full evaluation of the data and share results with the oncology community.