Bristol-Myers Squibb Co Stock Price, News & Analysis

Bristol Myers Squibb has received Marketing Authorization from the European Commission for Breyanzi (lisocabtagene maraleucel), a CAR T cell therapy designed for adults with relapsed or refractory large B-cell lymphoma. This approval is based on outcomes from the TRANSCEND trials, demonstrating a 73% response rate and a manageable safety profile. The approval marks the company's second CAR T therapy in the EU, expanding treatment options for patients facing limited choices. Breyanzi aims to address unmet medical needs in this patient population.

Bristol Myers Squibb has announced that the European Commission has approved Opdivo (nivolumab) combined with chemotherapy as a first-line treatment for adults with unresectable advanced esophageal squamous cell carcinoma (ESCC) with PD-L1 expression ≥ 1%. This approval is based on the Phase 3 CheckMate -648 trial, which showed a median overall survival of 15.44 months for Opdivo plus chemotherapy versus 9.07 months for chemotherapy alone. The safety profile aligns with previous studies, marking a significant advancement for patients in the EU.

Bristol Myers Squibb has received European Commission approval for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment for adults with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) with PD-L1 expression ≥ 1%. The approval follows results from the Phase 3 CheckMate-648 trial, highlighting a median overall survival of 13.70 months for patients treated with Opdivo plus Yervoy, compared to 9.07 months with chemotherapy. This treatment is now available in the EU, Iceland, Liechtenstein, and Norway.

Bristol Myers Squibb announced that the European Commission approved Opdivo (nivolumab) for adjuvant treatment of adults with muscle-invasive urothelial carcinoma, marking it as the first immunotherapy option approved in this setting in the EU. The approval is based on Phase 3 CheckMate -274 trial results, showing a 47% reduction in the risk of disease recurrence or death for patients with PD-L1 expression ≥1%, compared to placebo. Opdivo has now received EU approvals for three cancer types, enhancing its position in cancer treatment.

Bristol Myers Squibb (NYSE: BMY) announced favorable interim results from the EXPLORER-LTE cohort of the MAVA-LTE study, revealing sustained improvements in cardiac measures at 48 and 84 weeks for patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Key findings include a decrease in left ventricular outflow tract (LVOT) gradients and NYHA Class improvements in 67.5% of patients. The safety profile remained stable with no new adverse signals. The company anticipates FDA feedback on its New Drug Application by the end of the month.

Bristol Myers Squibb (NYSE: BMY) announced positive results from the Phase 3 VALOR-HCM study of mavacamten, a first-in-class cardiac myosin inhibitor. The study met all primary and secondary endpoints, demonstrating significant improvements in patients with symptomatic obstructive hypertrophic cardiomyopathy after 16 weeks. Notably, 82% of patients treated with mavacamten did not require septal reduction therapy, compared to only 23% in the placebo group. Safety data showed no new signals, validating mavacamten's efficacy as a potential treatment option.

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 June 27, 2022. This delay is due to a major amendment triggered by a written response to an FDA information request. Reblozyl is already approved for other anemia-related conditions and is being developed in partnership with Merck following its acquisition of Acceleron Pharma.

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.