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Bristol-Myers Squibb Co. (BMY) is a renowned American multinational pharmaceutical company headquartered in New York City. As one of the largest pharmaceutical companies globally, Bristol-Myers Squibb (BMS) consistently ranks on the Fortune 500 list. In fiscal 2022, the company achieved total revenue of $46.2 billion.
Bristol-Myers Squibb focuses on discovering, developing, and marketing drugs across various therapeutic areas, including cardiovascular, cancer, and immune disorders. A significant area of focus for BMS is immuno-oncology, where it has established itself as a leader in drug development. Approximately 70% of BMS's total sales are derived from the U.S. market, reflecting its higher dependence on this region compared to its peers.
Recent achievements and collaborations highlight BMS's commitment to innovation and partnerships. On May 22, 2024, BMS joined NeoPhore Limited's oversubscribed Series B extension round. This additional investment will enable NeoPhore to explore novel biology associated with the DNA mismatch repair (MMR) pathway in cancer, and further advance its pre-clinical studies. NeoPhore aims to generate next-generation immuno-oncology therapeutics to improve clinical outcomes for cancer patients.
Another noteworthy collaboration was announced on June 5, 2024, with I-Mab, a U.S.-based global biotech company. This partnership will evaluate the combination of givastomig, an investigational Claudin 18.2 x 4-1BB bispecific antibody, with BMS's immune checkpoint inhibitor, nivolumab, and chemotherapy. The study, a multi-national Phase 1, will focus on advanced Claudin 18.2-positive gastric and esophageal cancers. BMS will supply nivolumab, which is designed to enhance T-cell function and improve anti-tumor responses.
Additionally, on June 5, 2024, Envisagenics, an AI-driven biotechnology company, announced a Series B fundraising round with participation from BMS. This funding will be utilized to further develop Envisagenics' pipeline of novel preclinical oncology assets using their cloud-based AI drug discovery platform, SpliceCore®. This collaboration underscores BMS's continued investment in innovative technologies and therapeutics.
Bristol-Myers Squibb's mission is to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases. Through strategic partnerships, cutting-edge research, and a commitment to therapeutic advancements, BMS continues to make significant strides in the biopharmaceutical industry.
Bristol Myers Squibb (NYSE: BMY) announced FDA approval for OPDIVO® (nivolumab) combined with CABOMETYX® (cabozantinib) for first-line treatment of advanced renal cell carcinoma (RCC). The approval stemmed from the Phase 3 CheckMate-9ER trial, which demonstrated superior efficacy in progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) compared to sunitinib. Significant findings include a 40% reduction in mortality risk and a median PFS of 16.6 months for OPDIVO plus CABOMETYX. The combination could become a standard treatment for advanced kidney cancer.
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 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.
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