Bristol-Myers Squibb Co Stock Price, News & Analysis

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 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 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 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.