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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) received FDA approval for Opdivo Qvantig™, the first subcutaneously administered PD-1 inhibitor. This new formulation combines nivolumab with recombinant human hyaluronidase for most previously approved adult solid tumor Opdivo indications.
The approval is based on the Phase 3 CheckMate-67T trial results, which demonstrated non-inferior pharmacokinetics, similar efficacy in overall response rate (24% vs 18%), and comparable safety to intravenous Opdivo. A key advantage is the faster administration time of 3-5 minutes compared to 30-minute IV infusion.
The subcutaneous delivery method may offer greater flexibility for treatment location and reduced preparation time, potentially allowing patients to receive treatment closer to home.
Bristol Myers Squibb (NYSE: BMY) announced positive results from two pivotal Phase 3 trials, POETYK PsA-1 and POETYK PsA-2, evaluating Sotyktu (deucravacitinib) in adults with active psoriatic arthritis. Both trials met their primary endpoint, with significantly more Sotyktu-treated patients achieving ACR20 response (20% improvement in disease symptoms) after 16 weeks compared to placebo.
The trials also met important secondary endpoints across PsA disease activity at Week 16. The safety profile remained consistent with previous Phase 2 PsA and Phase 3 plaque psoriasis trials. These results represent the first Phase 3 trials for Sotyktu in a rheumatic condition, with the drug already approved globally for moderate-to-severe plaque psoriasis treatment.
Bristol Myers Squibb (BMY) has received European Commission approval for Opdivo plus Yervoy as first-line treatment for adult patients with MSI-H/dMMR metastatic colorectal cancer. The approval is based on the Phase 3 CheckMate -8HW trial results, which showed the dual immunotherapy combination reduced disease progression or death risk by 79% compared to chemotherapy.
The trial demonstrated significant progression-free survival (PFS) benefits, with median PFS not yet reached for Opdivo plus Yervoy versus 5.9 months for chemotherapy. The safety profile remained consistent with previous data, showing Grade 3/4 treatment-related adverse events in 23% of patients in the combination arm versus 48% in the chemotherapy arm.
Bristol Myers Squibb (NYSE: BMY) has announced it will release its fourth quarter 2024 financial results on Thursday, February 6, 2025. The company will host a conference call and live webcast at 8:00 a.m. ET on the same day, where executives will review financial results and address questions from investors and analysts.
Investors and the public can participate through a live webcast at investor.bms.com or by registering for the conference call. Those unable to register can dial 1-833-816-1116 (U.S. toll-free) or +1 412-317-0705 (international). A replay will be available until February 20, 2025.
BioArctic AB has entered into a global exclusive license agreement with Bristol Myers Squibb for its PyroGlutamate-amyloid-beta antibody program, including BAN1503 and BAN2803. The deal includes a $100 million upfront payment and up to $1.25 billion in milestone payments, plus tiered low double-digit royalties on global product sales.
The agreement covers BioArctic's novel antibodies targeting pyroglutamate modified amyloid-beta, which forms harmful aggregates causing Alzheimer's disease symptoms. BAN2803 incorporates BioArctic's BrainTransporter™ technology, designed to enhance brain drug delivery through the blood-brain barrier using the transferrin receptor. BioArctic retains co-commercialization rights in the Nordic region and all other rights for the BrainTransporter platform in different therapy areas.
Bristol Myers Squibb Foundation (BMS Foundation) is expanding its initiatives to improve lung cancer screening access across underserved communities in the United States. The foundation has awarded several significant grants, including $6.8 million for the QUILS™ program in Mississippi and Nevada, building on the success of Kentucky LEADS which achieved a 10% decline in late-stage diagnoses. Additionally, a $2.5 million grant was given to UCLA Health to lead CAL-PALS, targeting improved screening access in Los Angeles County.
The foundation is also collaborating with the U.S. Department of Veterans Affairs on the MAS-EXPAND study to research lung cancer risk factors in veterans. These initiatives aim to increase early detection rates, which can improve five-year survival rates from 4% to 55% when lung cancer is discovered early enough for surgical removal.
insitro has received $25 million from Bristol Myers Squibb (BMY) for achieving discovery milestones and selecting the first novel target for amyotrophic lateral sclerosis (ALS) treatment. The milestone stems from their 2020 collaboration agreement. Using their proprietary machine learning platform, insitro developed over 200 engineered and patient ALS cell lines, along with high-content imaging and pooled optical screening technology to identify disease mechanisms and genetic modifiers. The platform successfully identified several novel gene targets that showed promise in reversing ALS-related deficits. Under the agreement terms, insitro received a $50 million upfront payment and could earn up to $2 billion in additional milestones plus royalties.
Bristol Myers Squibb (NYSE: BMY) has announced a quarterly dividend increase of 3.3%, raising it to $0.62 per share from the previous $0.60. The dividend will be paid on February 3, 2025, to stockholders of record as of January 3, 2025. At this rate, the annual dividend for fiscal year 2025 will be $2.48 per share. This marks BMY's 16th consecutive year of dividend increases and 93rd consecutive year of dividend payments. Additionally, the company declared a quarterly dividend of $0.50 per share on its $2.00 convertible preferred stock, payable March 3, 2025, to stockholders of record as of February 4, 2025.
Bristol Myers Squibb (BMY) presented results from 18 studies at ASH 2024, showcasing progress in cell therapy across blood cancers and autoimmune diseases. Key highlights include long-term survival data for Breyanzi in lymphoma treatments, showing 38% 5-year overall survival rate and favorable safety profiles.
The company revealed first survival data for arlocabtagene autoleucel in multiple myeloma, demonstrating 87% overall response rate. New analysis showed 96.8% manufacturing success rate for Abecma globally. Additionally, updated results for CD19 NEX-T showed promise in treating severe autoimmune conditions, including lupus.
AI Proteins and Bristol Myers Squibb (NYSE: BMY) have entered a Research Collaboration and Option Agreement to develop novel miniprotein-based therapeutics. AI Proteins will receive an upfront payment to discover and optimize miniproteins for two undisclosed targets. BMY has options for exclusive worldwide licensing and two additional targets, with potential milestone payments up to $400M plus royalties. The collaboration leverages AI Proteins' AI-driven platform to design small, high-affinity proteins that offer advantages over traditional antibody therapies, including better tissue penetration and rapid clearance.