Bristol-Myers Squibb Co Stock Price, News & Analysis

Bristol Myers Squibb (NYSE:BMY) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Opdivo (nivolumab) for adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) post chemotherapy. This opinion is based on the Phase 3 ATTRACTION-3 trial, showing significant overall survival improvement and favorable safety. If approved by the European Commission, it will be a landmark as the first immunotherapy for upper gastrointestinal cancers in the EU.

Bristol Myers Squibb (NYSE:BMY) announced results from the Phase 3 True North trial for Zeposia (ozanimod) in patients with moderate to severe ulcerative colitis. The trial met primary endpoints, showing significant clinical remission rates at Week 10 (18.4% vs 6.0%) and Week 52 (37.0% vs 18.5%), both with p-values < 0.0001. Key secondary endpoints, including clinical response and mucosal healing, also showed significant improvements. The safety profile aligns with previous data. A virtual Investor Event is scheduled for October 12, 2020, to discuss these results.

Bristol Myers Squibb (NYSE: BMY) has announced a definitive merger agreement to acquire MyoKardia (Nasdaq: MYOK) for $13.1 billion, or $225.00 per share in cash. This acquisition, expected to close in Q4 2020, will enhance Bristol Myers Squibb's portfolio with mavacamten, a potential first-in-class treatment for obstructive hypertrophic cardiomyopathy (HCM). The New Drug Application for mavacamten is anticipated for submission to the FDA in Q1 2021. The acquisition is expected to add significant growth drivers and is projected to be minimally dilutive to non-GAAP EPS in 2021 and 2022, and accretive by 2023.

Bristol Myers Squibb (NYSE: BMY) announced results from the CheckMate -915 Phase 3 study, evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus Opdivo alone for patients with completely resected stage IIIb/c/d or stage IV melanoma. The combination did not show a statistically significant improvement in recurrence-free survival (RFS) compared to Opdivo monotherapy. Despite this, Opdivo remains a standard treatment in the adjuvant setting. The safety profiles for both regimens were consistent with prior studies, and no new safety signals were reported.

Bristol Myers Squibb (NYSE: BMY) has received FDA approval for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment for adults with unresectable malignant pleural mesothelioma (MPM). This decision stems from the Phase 3 CheckMate -743 trial, demonstrating a significant improvement in overall survival. Patients treated with Opdivo + Yervoy had a median overall survival of 18.1 months compared to 14.1 months for chemotherapy. This marks the first systemic therapy for MPM in over 15 years, providing new hope for patients facing this aggressive cancer.

Bristol Myers Squibb (NYSE:BMY) will host a virtual Investor Event on October 12, 2020, at 8:00 a.m. EDT. The event will focus on the results from the Phase 3 True North trial of Zeposia® (ozanimod) for treating moderate to severe ulcerative colitis, to be presented at UEG Week 2020. Executives will provide insights and answer questions from investors and analysts. The public can access the live webcast on the company's investor site, with an archived version available later the same day.

Bristol Myers Squibb (NYSE: BMY) and UNCF announced the second cohort of the Ernest E. Just Postgraduate Fellowship in Life Sciences, extending their partnership through 2026. Dr. Antentor Hinton Jr. and Dr. Cornelius Taabazuing have received this competitive fellowship aimed at supporting African American scientists. This initiative will select eight cohorts over the next several years, enhancing the transition of fellows into independent careers in academia or biopharma R&D.

The fellowship honors Dr. Ernest Everett Just and includes a stipend, research budget, and networking opportunities.

Bristol Myers Squibb (NYSE:BMY) has exercised its option for an exclusive worldwide license to a cell therapy candidate utilizing Obsidian Therapeutics' cytoDRiVE™ technology, which aims to control the expression of CD40L, an immunomodulatory factor. This marks the first opt-in decision from Bristol Myers since their collaboration began in January 2019. Obsidian stands to receive potential milestone and royalty payments as part of this agreement, signaling validation of its innovative platform and the advancement of its pipeline programs in cancer therapies.

Vidence, LLC, launched on June 18, 2020, aims to enhance cancer treatment through its SCIMON platform, which integrates clinical and genomic data. This oncology informatics company helps researchers and healthcare providers accelerate cancer treatment innovations. Notably, Vidence collaborates with Bristol Myers Squibb (NYSE: BMY) to analyze treatment patterns and outcomes from a large dataset of over 100,000 patients. The collaboration seeks to improve patient care and outcomes in oncology by utilizing a comprehensive knowledge base.