Welcome to our dedicated page for Bristol-Myers Squibb news (Ticker: BMY), a resource for investors and traders seeking the latest updates and insights on Bristol-Myers Squibb stock.
Bristol Myers Squibb reports news on its pharmaceutical portfolio across oncology, cardiovascular disease and immunology, including regulatory decisions, clinical trial data, commercial access programs and product collaborations. Company updates include Sotyktu (deucravacitinib), a selective TYK2 inhibitor approved in the European Union for active psoriatic arthritis, and Eliquis (apixaban), an oral anticoagulant marketed through the Bristol Myers Squibb-Pfizer alliance.
Recurring developments also cover quarterly financial results, investor conference participation, debt and capital-market activity, research collaborations in cardiovascular and precision-medicine programs, and community initiatives tied to multiple myeloma care. The company’s news flow combines product-specific regulatory milestones with broader disclosures on operating performance and pipeline partnerships.
Bristol Myers Squibb (NYSE: BMY) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) for the use of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment of unresectable malignant pleural mesothelioma (MPM). This marks a significant advancement, as it has been over 15 years since new treatments have been approved for MPM. The European Commission will now review this recommendation, which is based on the encouraging results of the CheckMate -743 trial, showcasing superior overall survival compared to chemotherapy.
Bristol Myers Squibb announced FDA approval for Opdivo (nivolumab) in combination with chemotherapy for treating patients with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, regardless of PD-L1 expression. This approval stems from the Phase 3 CheckMate -649 trial, where Opdivo plus chemotherapy improved overall survival (OS) and reduced the risk of disease progression. Notably, one-year survival rates reached 55% with Opdivo compared to 48% for chemotherapy alone. The approval was expedited through the FDA's Real-Time Oncology Review program.
Bristol Myers Squibb (NYSE: BMY) has received approval from the European Commission for Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) as a first-line treatment for adults with advanced renal cell carcinoma (RCC). This decision follows the successful Phase 3 CheckMate -9ER trial, highlighting superior efficacy in key endpoints such as progression-free survival and overall survival compared to sunitinib. The combination treatment demonstrated manageable safety with low treatment-related discontinuations, broadening options for RCC patients in Europe.
Bristol Myers Squibb (NYSE: BMY) reported significant results from the CheckMate -816 study, demonstrating that neoadjuvant treatment with Opdivo (nivolumab) plus chemotherapy resulted in a pathologic complete response (pCR) of 24% compared to 2.2% for chemotherapy alone (p0.0001). This trial is the first Phase 3 study showing improved pCR in resectable stage Ib to IIIa . Additionally, Opdivo plus chemotherapy was well tolerated, with no new safety signals detected. The findings suggest potential benefits for long-term survival in NSCLC patients.
Bristol Myers Squibb (NYSE: BMY) announced positive topline results from the Phase 3 CheckMate -648 trial, which evaluated the combination of Opdivo (nivolumab) with chemotherapy or Yervoy (ipilimumab) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). Results showed significant improvements in overall survival (OS) and progression-free survival (PFS) for both combinations in patients expressing PD-L1. The safety profiles were consistent with previous reports. Upcoming data will be shared at a medical conference and with health authorities.
HUYABIO International has announced a clinical collaboration with Bristol-Myers Squibb to conduct a Phase 3 trial evaluating the combination of HBI-8000 and Opdivo® (nivolumab) for treating unresectable or metastatic melanoma. Following a successful Phase 2 study that reported an overall response rate above 70%, this trial aims to further assess safety and efficacy. HBI-8000 is an epigenetic immunomodulator already approved for lymphoma and metastatic breast cancer in China.
Bristol Myers Squibb (NYSE:BMY) will host a virtual Investor Event on April 23, 2021, at 10:30 a.m. ET. The event will discuss data from the Phase 3 trials POETYK PSO-1 and PSO-2 of deucravacitinib, focused on treating moderate-to-severe psoriasis. The findings will be presented during the American Academy of Dermatology Virtual Meeting Experience (AAD VMX). Investors and the public can access the live webcast and materials at investor.bms.com, with an archived version available later the same day.
Bristol Myers Squibb (BMY) announced the validation of its type II variation application by the European Medicines Agency for Opdivo (nivolumab) to treat high-risk muscle-invasive urothelial carcinoma post-surgery. This validation confirms a complete submission, initiating the EMA’s centralized review. Opdivo showed significant potential in reducing cancer recurrence risk in the CheckMate -274 trial, with a strong safety profile. The application marks a step towards providing a first adjuvant immunotherapy option for this patient demographic in the EU.
Bristol Myers Squibb (NYSE: BMY) announced positive primary results from the Phase 2/3 RELATIVITY-047 trial, demonstrating that the fixed-dose combination of relatlimab and Opdivo significantly improved progression-free survival (PFS) in patients with untreated metastatic or unresectable melanoma compared to Opdivo alone. This marks the first Phase 3 data involving an anti-LAG-3 antibody. The combination therapy was well-tolerated, with no new safety signals. Follow-up on overall survival is ongoing. These findings could enhance treatment options for melanoma patients.
Bristol Myers Squibb (NYSE: BMY) announced the FDA's acceptance of its New Drug Application (NDA) for mavacamten, an oral allosteric modulator aimed at treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The FDA set a PDUFA goal date for January 28, 2022. Clinical results from the Phase 3 EXPLORER-HCM trial indicated that mavacamten met primary and secondary endpoints, showcasing significant symptom relief and improved quality of life for patients. This first-in-class therapy addresses the underlying molecular defect of oHCM, a condition affecting approximately 160,000 to 200,000 people in the U.S. and EU.