Bristol-Myers Squibb Co. - BMY STOCK NEWS

Bristol Myers Squibb (NYSE: BMY) presented comprehensive research on its cardiovascular portfolio at the American Heart Association's annual Scientific Sessions from November 13-15, 2021. Key presentations included results from the AXIOMATIC-TKR study, exploring milvexian's efficacy in total knee replacement surgery, and analyses on mavacamten for obstructive hypertrophic cardiomyopathy. Researchers emphasized commitment to advancing treatment options for cardiovascular disease, a leading global health issue.

Bristol Myers Squibb (NYSE: BMY) announced that its Phase 3 CheckMate -816 trial successfully met the primary endpoint of improved event-free survival (EFS) in patients with resectable stage IB to IIIA non-small cell lung cancer (NSCLC). The combination of Opdivo (nivolumab) and chemotherapy showed significant EFS benefits compared to chemotherapy alone in a prespecified interim analysis. This is the first Phase 3 trial with an immunotherapy-based combination to demonstrate substantial efficacy in a neoadjuvant setting, marking a pivotal advancement in the treatment of NSCLC.

Bristol Myers Squibb (NYSE: BMY) announced a significant presence at the 63rd ASH Annual Meeting, showcasing research on hematologic diseases, including data from over 80 studies. Key presentations include results from the Phase 3 TRANSFORM study of Breyanzi (lisocabtagene maraleucel) against standard care for relapsed or refractory large B-cell lymphoma and new findings on CELMoD therapies like iberdomide. The company highlights its commitment to innovation in treatments for multiple myeloma, lymphoma, and myeloid diseases aimed at improving patient outcomes.

Bristol Myers Squibb (NYSE:BMY) showcased its commitment to rheumatology by presenting significant data on Orencia and deucravacitinib at the American College of Rheumatology (ACR) Convergence 2021. The presentations covered 29 studies, with key findings revealing that patients treated with Orencia showed improved disease activity scores in rheumatoid arthritis, especially among seropositive patients. Additionally, deucravacitinib, an oral TYK2 inhibitor, demonstrated promising results in the treatment of psoriatic arthritis, highlighting the company’s focus on innovative therapies for immune-mediated diseases.

Bristol Myers Squibb (NYSE:BMY) reported third quarter 2021 revenues of $11.6 billion, marking a 10% year-over-year increase. The GAAP earnings per share (EPS) was $0.69, a 16% decline, while non-GAAP EPS rose 23% to $2.00. The company's growth was driven by strong sales of Revlimid, Eliquis, and new products. Key regulatory advancements include FDA priority review for the relatlimab and nivolumab combination in melanoma. Updated full-year guidance indicates a reduction in GAAP EPS expectations to $2.68 - $2.83 and non-GAAP EPS to $7.40 - $7.55.

Bristol Myers Squibb (BMY) has announced a rescheduled earnings conference call to discuss its third quarter 2021 results. The call will take place on October 27, 2021, at 10:00 a.m. ET. Company executives will review financial results and address investor inquiries. A live webcast of the call will be accessible at investor.bms.com, and a replay will be available from 1:30 p.m. ET on October 27 through 1:30 p.m. ET on November 10, 2021.

Bristol Myers Squibb has received European Commission approval for its drug Opdivo (nivolumab) in combination with chemotherapy for the first-line treatment of adult patients with HER2-negative, advanced gastric cancers. This approval is based on the successful Phase 3 CheckMate -649 trial, showing a significant improvement in overall survival (14.4 months vs. 11.1 months) and progression-free survival (8.31 months vs. 6.05 months) compared to chemotherapy alone. The treatment is now available across the EU and in additional countries, benefiting patients with specific tumor characteristics.

Dr. Reddy’s Laboratories has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules in 2.5 mg and 20 mg strengths, with tentative approvals for other strengths. This positions the company to gain 180 days of generic drug exclusivity for these products. The approval follows a settlement with Celgene (Bristol Myers Squibb) regarding REVLIMID® patents, which also allows Dr. Reddy’s to market generic versions starting from January 31, 2026. This development aims to provide a more affordable option for patients.

Bristol Myers Squibb announced that the CHMP of the EMA has recommended approval for Zeposia (ozanimod) to treat adults with moderately to severely active ulcerative colitis. This recommendation is based on positive results from the Phase 3 True North study, which showed substantial improvements in multiple clinical endpoints. If approved by the European Commission, Zeposia will be the first oral S1P receptor modulator available for ulcerative colitis in the EU. The U.S. FDA previously approved Zeposia for the same condition in May 2021.