Bristol-Myers Squibb Co - BMY STOCK NEWS

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.

Bristol Myers Squibb (NYSE: BMY) has declared a quarterly dividend of $0.54 per share on its common stock, payable on May 2, 2022, to stockholders of record by April 1, 2022. Additionally, a quarterly dividend of $0.50 per share on its convertible preferred stock will be paid on June 1, 2022, with a record date of May 10, 2022. This consistent dividend policy reflects confidence in the company’s ongoing financial health and commitment to returning value to shareholders.

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.