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Bristol-Myers Squibb Company (BMY) is a global biopharmaceutical leader developing innovative therapies in oncology, cardiovascular diseases, and immunology. This dedicated news hub provides investors and healthcare professionals with direct access to BMY's latest developments, including FDA approvals, clinical trial results, and strategic partnerships.
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Bristol Myers Squibb (NYSE: BMY) reported significant results from the CheckMate -816 study, demonstrating that neoadjuvant treatment with Opdivo (nivolumab) plus chemotherapy resulted in a pathologic complete response (pCR) of 24% compared to 2.2% for chemotherapy alone (p<0.0001). This trial is the first Phase 3 study showing improved pCR in resectable stage Ib to IIIa non-small cell lung cancer (NSCLC). Additionally, Opdivo plus chemotherapy was well tolerated, with no new safety signals detected. The findings suggest potential benefits for long-term survival in NSCLC patients.
Bristol Myers Squibb (NYSE: BMY) announced positive topline results from the Phase 3 CheckMate -648 trial, which evaluated the combination of Opdivo (nivolumab) with chemotherapy or Yervoy (ipilimumab) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). Results showed significant improvements in overall survival (OS) and progression-free survival (PFS) for both combinations in patients expressing PD-L1. The safety profiles were consistent with previous reports. Upcoming data will be shared at a medical conference and with health authorities.
HUYABIO International has announced a clinical collaboration with Bristol-Myers Squibb to conduct a Phase 3 trial evaluating the combination of HBI-8000 and Opdivo® (nivolumab) for treating unresectable or metastatic melanoma. Following a successful Phase 2 study that reported an overall response rate above 70%, this trial aims to further assess safety and efficacy. HBI-8000 is an epigenetic immunomodulator already approved for lymphoma and metastatic breast cancer in China.
Bristol Myers Squibb (NYSE:BMY) will host a virtual Investor Event on April 23, 2021, at 10:30 a.m. ET. The event will discuss data from the Phase 3 trials POETYK PSO-1 and PSO-2 of deucravacitinib, focused on treating moderate-to-severe psoriasis. The findings will be presented during the American Academy of Dermatology Virtual Meeting Experience (AAD VMX). Investors and the public can access the live webcast and materials at investor.bms.com, with an archived version available later the same day.
Bristol Myers Squibb (BMY) announced the validation of its type II variation application by the European Medicines Agency for Opdivo (nivolumab) to treat high-risk muscle-invasive urothelial carcinoma post-surgery. This validation confirms a complete submission, initiating the EMA’s centralized review. Opdivo showed significant potential in reducing cancer recurrence risk in the CheckMate -274 trial, with a strong safety profile. The application marks a step towards providing a first adjuvant immunotherapy option for this patient demographic in the EU.
Bristol Myers Squibb (NYSE: BMY) announced positive primary results from the Phase 2/3 RELATIVITY-047 trial, demonstrating that the fixed-dose combination of relatlimab and Opdivo significantly improved progression-free survival (PFS) in patients with untreated metastatic or unresectable melanoma compared to Opdivo alone. This marks the first Phase 3 data involving an anti-LAG-3 antibody. The combination therapy was well-tolerated, with no new safety signals. Follow-up on overall survival is ongoing. These findings could enhance treatment options for melanoma patients.
Bristol Myers Squibb (NYSE: BMY) announced the FDA's acceptance of its New Drug Application (NDA) for mavacamten, an oral allosteric modulator aimed at treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The FDA set a PDUFA goal date for January 28, 2022. Clinical results from the Phase 3 EXPLORER-HCM trial indicated that mavacamten met primary and secondary endpoints, showcasing significant symptom relief and improved quality of life for patients. This first-in-class therapy addresses the underlying molecular defect of oHCM, a condition affecting approximately 160,000 to 200,000 people in the U.S. and EU.
Bristol Myers Squibb (NYSE:BMY) will release its first-quarter results on April 29, 2021, at 9 a.m. ET. Company executives will discuss financial performance and respond to investor inquiries during a conference call. Interested parties can access the live webcast at investor.bms.com or by dialing 800-458-4121 (U.S.) or +1 313-209-6672 (international) with confirmation code 3705525. A replay will be available from April 29 at 12:30 p.m. ET until May 13, 2021. For more information, visit BMS.com.
Bristol Myers Squibb (NYSE: BMY) will participate in a fireside chat at Barclays’ Virtual Global Healthcare Conference on March 9, 2021, at 3 p.m. ET. David Elkins, Executive Vice President and Chief Financial Officer, will address investor questions during the session. Investors and the public can access the live webcast at investor.bms.com, with materials available at the beginning of the event and an archived version posted later that day. The company focuses on developing innovative medicines for serious diseases.
Bristol Myers Squibb (NYSE: BMY) announced a quarterly dividend of $0.49 per share on its common stock, payable on May 3, 2021, to stockholders of record by April 1, 2021. Additionally, a dividend of $0.50 per share on its convertible preferred stock will be paid on June 1, 2021, to stockholders recorded by May 4, 2021. This reflects the company's commitment to returning value to shareholders while continuing to innovate in biopharmaceuticals.