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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 announced the European Medicines Agency's validation of its application for Opdivo in combination with chemotherapy for neoadjuvant treatment of resectable stage IB to IIIA non-small cell lung cancer (NSCLC). This regimen aims to be the first immunotherapy-based option before surgery in the EU, based on results from the CheckMate-816 trial, which showed significant improvements in event-free survival and pathologic complete response. Opdivo's safety profile remains consistent with previous studies.
Bristol Myers Squibb (NYSE: BMY) announced an extension of the FDA review for the supplemental biologics license application (sBLA) of Reblozyl (luspatercept-aamt), treating anemia in adults with non-transfusion-dependent beta thalassemia, now due by
Bristol Myers Squibb (NYSE: BMY) shared recent findings from its cardiovascular research at the American College of Cardiology’s 71st Annual Scientific Session, held from April 2-4, 2022. The highlights include two late-breaking clinical trials on mavacamten, an investigational treatment for obstructive hypertrophic cardiomyopathy (HCM). These presentations emphasize the company's dedication to addressing cardiovascular diseases and improving patient outcomes. Key studies featured included the Phase 3 VALOR-HCM study and the GUARD-AF study on atrial fibrillation.
Bristol Myers Squibb announced that the FDA has approved Opdualag, a fixed-dose dual immunotherapy combining nivolumab and relatlimab, for patients aged 12 and older with unresectable or metastatic melanoma. This innovative treatment showed a median progression-free survival of 10.1 months, more than doubling the 4.6 months seen with nivolumab alone in the RELATIVITY-047 trial. The safety profile is consistent with nivolumab, with 14.6% of patients experiencing drug-related adverse events leading to discontinuation. This marks a significant expansion of treatment options for melanoma patients.
Bristol Myers Squibb (NYSE: BMY) and Nektar Therapeutics (NASDAQ: NKTR) reported disappointing results from the Phase 3 PIVOT IO-001 study evaluating bempegaldesleukin plus Opdivo versus Opdivo alone in metastatic melanoma. The independent Data Monitoring Committee found no significant benefits in progression-free survival (PFS) or objective response rate (ORR). Consequently, the companies decided to unblind the trial and halt enrollment for the related PIVOT-12 study. The focus will now shift to ongoing studies in renal cell carcinoma and bladder cancer.
Bristol Myers Squibb (NYSE:BMY) will report its first quarter 2022 financial results on
Bristol Myers Squibb (NYSE: BMY) announced its participation in investor conferences on
Bristol Myers Squibb (NYSE: BMY) announced FDA approval for Opdivo® (nivolumab) in combination with platinum-doublet chemotherapy as the first immunotherapy-based treatment for resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting. This approval follows the Phase 3 CheckMate -816 trial, demonstrating a 37% reduction in progression risk and a median event-free survival of 31.6 months with Opdivo, compared to 20.8 months for chemotherapy alone. The approval enhances treatment options prior to surgery, regardless of PD-L1 status.
Bristol-Myers Squibb Company (NYSE:BMY) announced the accepted amounts and pricing for their 22 separate cash offers to purchase notes. Key details include:
- Majority of 2025 and 2026 Pool Notes accepted with yields of 1.961% and 1.842% respectively.
- A total principal amount of $1.6 billion accepted from the 2029 Pool Notes with a yield of 2.356%.
- The Offers are set to expire on March 15, 2022, unless extended.
All accepted Notes will be cancelled, with the Early Settlement Date occurring on March 4, 2022.
Bristol-Myers Squibb (NYSE: BMY) announced early results for its tender offers, with a new maximum purchase price up to $4 billion for multiple series of notes. As of March 1, 2022, significant tendering was reported, including $821.88 million for 2025 notes and $1.45 billion for 2026 notes. The offers include various pools, such as 2025, 2026, and high coupon notes. The deadline for acceptance is set for March 15, 2022. The company will issue a press release on March 2, 2022, detailing the accepted amounts and yields.