Bristol-Myers Squibb Co Stock Price, News & Analysis

Dragonfly Therapeutics has achieved a significant milestone in its Phase 1 clinical trial for the DF6002/BMS-9896415 IL-12 program, receiving a milestone payment from Bristol Myers Squibb (BMY). DF6002, an investigational monovalent IL-12 immunoglobulin Fc fusion protein, aims to enhance anti-tumor responses in patients with advanced solid tumors. The trial, which began in July 2020, focuses on assessing the safety and anti-tumor activity of DF6002. With Bristol Myers Squibb responsible for development and commercialization, Dragonfly stands to gain further milestone payments and royalties on net sales.

Bristol Myers Squibb has announced the FDA's acceptance of its supplemental Biologics License Application for Opdivo plus chemotherapy, targeting resectable non-small cell lung cancer (NSCLC). This application, based on the CheckMate -816 trial results, has received Priority Review status, with a PDUFA goal date set for July 13, 2022. The CheckMate -816 trial indicated significant improvements in pathologic complete response and event-free survival when compared to chemotherapy alone. If approved, this would be the first immunotherapy-based neoadjuvant treatment option for NSCLC in the U.S., addressing a critical need in early-stage lung cancer treatment.

Bristol Myers Squibb (NYSE:BMY) has received a positive opinion from the CHMP for the combination therapy of Opdivo (nivolumab) and chemotherapy for first-line treatment of adults with unresectable advanced esophageal squamous cell carcinoma (ESCC) with PD-L1 expression ≥1%. This recommendation is based on the Phase 3 CheckMate -648 trial, which showed a significant overall survival benefit (median 15.4 months vs. 9.1 months) for the combination versus chemotherapy alone. The European Commission will review this opinion next.

Bristol Myers Squibb (NYSE:BMY) announced a positive CHMP opinion recommending approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line treatment of unresectable advanced esophageal squamous cell carcinoma (ESCC) with PD-L1 expression ≥1%. This follows promising results from the Phase 3 CheckMate -648 trial, where the combination therapy showed a median overall survival of 13.7 months compared to 9.1 months for chemotherapy (HR = 0.64; p=0.001). The European Commission will now review this recommendation.

Biohaven Pharmaceutical announced a worldwide licensing agreement with Bristol Myers Squibb for the development of taldefgrobep alfa, a Phase 3-ready anti-myostatin adnectin targeted at treating Spinal Muscular Atrophy (SMA). This is Biohaven's third license from Bristol Myers Squibb, with the trial expected to commence in 2022. Taldefgrobep aims to enhance muscle mass and strength in patients with neuromuscular diseases, representing a potential breakthrough in treatment strategies. The agreement includes milestone payments and sales-based royalties for Bristol Myers Squibb.

Bristol Myers Squibb (NYSE: BMY) has received a positive recommendation from the European Medicines Agency's CHMP for the approval of Opdivo (nivolumab) for adjuvant treatment of adults with muscle-invasive urothelial carcinoma at high risk of recurrence post-surgery.

This recommendation is based on the Phase 3 CheckMate -274 trial results, which showed significant disease-free survival improvement with Opdivo versus placebo. If approved, it would be the first adjuvant immunotherapy option in Europe for this patient group.

Bristol Myers Squibb (NYSE: BMY) announced positive interim results from the True North study, revealing sustained efficacy of Zeposia (ozanimod) in treating moderately to severely active ulcerative colitis through Week 142. Key findings include that 45% to 51% of patients achieved clinical remission at Weeks 46, 94, and 142, while clinical response rates ranged from 80% to 86%. No new safety signals emerged, reinforcing Zeposia as a significant treatment option in this patient group. The data will be presented at the ECCO 2022 Congress.

Bristol Myers Squibb announced that the FDA has accepted its supplemental Biologics License Application for Breyanzi, a CAR T cell therapy, seeking to expand its use for adults with relapsed or refractory large B-cell lymphoma after first-line therapy failure. The application received Priority Review status, with a target action date of June 24, 2022.

Results from the pivotal Phase 3 TRANSFORM study indicated Breyanzi provided significant improvements in event-free survival and overall outcomes compared to standard chemotherapy treatments.

Bristol Myers Squibb (NYSE: BMY) announced that its Phase 3 VALOR-HCM trial evaluating mavacamten for symptomatic obstructive hypertrophic cardiomyopathy met its primary endpoint at Week 16. The trial involved over 100 patients and showed consistent safety results with previous studies. Mavacamten aims to improve patient outcomes eligible for septal reduction therapy. The firm plans to submit these findings to regulatory authorities and will present more data at the American College of Cardiology's Annual Scientific Session in April.