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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 has received European Commission approval for its drug Opdivo (nivolumab) in combination with chemotherapy for the first-line treatment of adult patients with HER2-negative, advanced gastric cancers. This approval is based on the successful Phase 3 CheckMate -649 trial, showing a significant improvement in overall survival (14.4 months vs. 11.1 months) and progression-free survival (8.31 months vs. 6.05 months) compared to chemotherapy alone. The treatment is now available across the EU and in additional countries, benefiting patients with specific tumor characteristics.
Dr. Reddy’s Laboratories has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules in 2.5 mg and 20 mg strengths, with tentative approvals for other strengths. This positions the company to gain 180 days of generic drug exclusivity for these products. The approval follows a settlement with Celgene (Bristol Myers Squibb) regarding REVLIMID® patents, which also allows Dr. Reddy’s to market generic versions starting from January 31, 2026. This development aims to provide a more affordable option for patients.
Bristol Myers Squibb announced that the CHMP of the EMA has recommended approval for Zeposia (ozanimod) to treat adults with moderately to severely active ulcerative colitis. This recommendation is based on positive results from the Phase 3 True North study, which showed substantial improvements in multiple clinical endpoints. If approved by the European Commission, Zeposia will be the first oral S1P receptor modulator available for ulcerative colitis in the EU. The U.S. FDA previously approved Zeposia for the same condition in May 2021.
Bristol Myers Squibb (NYSE: BMY) announced promising interim results from the Phase 3 DAYBREAK trial, focusing on the long-term efficacy of Zeposia (ozanimod) for relapsing forms of multiple sclerosis (MS). Key findings revealed a low annualized relapse rate (ARR) of 0.103, with over 70% of participants relapse-free after four years. Safety profiles remained consistent with earlier studies, with no new safety signals emerging. The data emphasizes Zeposia's role in early intervention for MS patients, showcasing its potential in improving long-term outcomes.
Bristol Myers Squibb (NYSE: BMY) announced that the Phase 2 LATTICE-UC study for deucravacitinib, a selective TYK2 inhibitor for moderate to severe ulcerative colitis, failed to meet its primary endpoint of clinical remission at Week 12, as well as secondary endpoints. Despite this, the drug's safety profile remained consistent with earlier studies, showing no new safety signals. The company plans further evaluation in a second Phase 2 trial with higher doses. Notably, they maintain a revenue target of over $4 billion for deucravacitinib by 2029.
Bristol Myers Squibb (NYSE: BMY) announced an Investor Event scheduled for November 16, 2021, at 9:30 a.m. ET in New York City. Giovanni Caforio, CEO, will discuss the company’s strategy, pipeline, and business opportunities with the leadership team. This event will be webcast, allowing broader access to the discussion. Materials related to the presentation will be available at the webcast's start, and a replay will be accessible afterward. Bristol Myers Squibb is committed to developing innovative medicines for serious diseases.
Bristol Myers Squibb (BMY) has announced the validation of its Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for the LAG-3-blocking antibody relatlimab in combination with nivolumab for treating advanced melanoma. This application follows significant results from the Phase 2/3 RELATIVITY-047 trial, showing a meaningful progression-free survival benefit over standard therapy. If approved, this would be the first treatment of its kind available in the EU, positioning BMY for a critical advancement in oncology.
Bristol Myers Squibb (NYSE: BMY) has announced the validation of its Marketing Authorization Application (MAA) for mavacamten, a first-in-class cardiac myosin inhibitor aimed at treating obstructive hypertrophic cardiomyopathy (HCM). This validation by the European Medicines Agency (EMA) is based on the positive outcomes from the Phase 3 EXPLORER-HCM trial, where mavacamten significantly improved symptoms and quality of life for patients. If approved, mavacamten would be the first therapy targeting the underlying cause of obstructive HCM.
Bristol Myers Squibb (BMY) announced that the FDA accepted supplemental Biologics License Applications for Opdivo in combination with Yervoy and chemotherapy as first-line treatments for unresectable advanced esophageal squamous cell carcinoma (ESCC). This submission is based on results from the Phase 3 CheckMate -648 trial, which showed significant overall survival benefits compared to chemotherapy. The FDA set a target action date of May 28, 2022. The company emphasizes the need for additional treatment options for the 19,000 esophageal cancer patients diagnosed annually in the U.S.
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