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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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Discover timely information on therapeutic advancements in immuno-oncology and hematology, plus insights into global healthcare trends affecting pharmaceutical operations. Bookmark this page for streamlined monitoring of BMY's scientific innovations and corporate announcements essential for informed analysis.
Bristol Myers Squibb (NYSE: BMY) has received a positive CHMP opinion for a new subcutaneous formulation of Opdivo® (nivolumab) across multiple solid tumor indications. The recommendation is based on the Phase 3 CheckMate -67T trial, which demonstrated noninferiority in pharmacokinetics and consistent efficacy compared to the intravenous formulation.
The trial showed an objective response rate of 24% for subcutaneous Opdivo versus 18% for IV Opdivo. The safety profile remained consistent between both formulations. The European Commission's final decision is expected by June 2, 2025.
The subcutaneous formulation, co-formulated with recombinant human hyaluronidase (rHuPH20), offers potential benefits including reduced administration time and improved healthcare system efficiency. The U.S. FDA has already approved this formulation under the brand name Opdivo Qvantig on December 27, 2024.
Viz.ai announced new clinical data showing the effectiveness of its Viz HCM module, developed in partnership with Bristol Myers Squibb (NYSE:BMY), in detecting hypertrophic cardiomyopathy (HCM). The module, which received FDA De Novo approval in August 2023, is the first AI algorithm cleared for HCM detection.
Four studies presented at ACC 2025 demonstrated significant results:
- Cleveland Clinic study identified 574 HCM patients with high accuracy
- 20% of patients could have been diagnosed more than one year earlier
- In a multicenter study of 145,848 screened patients, 3% were flagged for suspected HCM, leading to 17 new HCM diagnoses
- Algorithm showed 56% sensitivity and 100% specificity in detecting HCM confirmed by cardiac MRI
Cardurion Pharmaceuticals has appointed Karen Lewis as Chief People Officer, bringing over 25 years of human resources experience to the clinical-stage biotechnology company. Lewis joins from Apellis Pharmaceuticals (APLS), where she served as Chief People Officer and led organizational growth from 200 to over 900 employees globally while supporting the launch of two drug products.
Prior to Apellis, Lewis held leadership positions at Axcella Health, Biogen (BIIB), Amazon, and Bristol-Myers Squibb (BMY). At Biogen, she served as Vice President of Global Talent Acquisition and headed HR for U.S. commercial and Asia Pacific/Latin America operations. Lewis holds a B.S. in biology from Rider University and began her career as a research scientist before transitioning to HR.
Bristol Myers Squibb (NYSE: BMY) has received European Commission approval for Breyanzi to treat adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
The approval is based on the Phase 2 TRANSCEND FL study results, showing:
- 97.1% overall response rate
- 94.2% complete response rate
- 75.7% of patients maintained response at 18 months
- Median time to first response of 0.95 months
Safety profile remained consistent with previous trials, with 58% of patients experiencing cytokine release syndrome (only 0.8% Grade 3) and 16% experiencing neurologic toxicities (3% Grade 3). The approval extends to all EU member states and EEA countries.
Bristol Myers Squibb (NYSE: BMY) has scheduled its first quarter 2025 financial results announcement for Thursday, April 24, 2025. The company will host a conference call and webcast at 8:00 a.m. ET where executives will discuss the quarterly results with the investment community.
Investors and the public can access the live webcast through the company's investor relations website at http://investor.bms.com. Related materials will be available on the same platform before the call begins. A replay of the webcast will be accessible approximately three hours after the conference call ends.
2seventy bio (TSVT) has entered into a definitive merger agreement to be acquired by Bristol Myers Squibb (BMY) in an all-cash transaction valued at $5.00 per share. The deal represents a total equity value of approximately $286 million, or $102 million net of estimated cash, offering an 88% premium to the closing price of $2.66 on March 7, 2025.
The transaction is expected to close in Q2 2025, subject to customary conditions including tender of majority shares and Hart-Scott-Rodino Act requirements. Stockholders owning approximately 5.3% of 2seventy bio's common stock have agreed to tender their shares. Following completion, 2seventy bio will be delisted from Nasdaq.
The strategic focus of the acquisition centers on Abecma, a B-cell maturation antigen-directed genetically modified autologous T cell immunotherapy for multiple myeloma treatment. Goldman Sachs & Co. serves as exclusive financial advisor to 2seventy bio, with Goodwin Procter LLP as legal counsel.
Bristol Myers Squibb (NYSE:BMY) announced positive results from its Phase 3 POETYK PsA-2 trial evaluating Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). The trial met its primary endpoint, with 54.2% of Sotyktu-treated patients achieving ACR20 response compared to 39.4% for placebo at Week 16 (p=0.0002).
Key secondary endpoints were also met, including significant improvements in PASI 75 response and Health Assessment Questionnaire-Disability Index (HAQ-DI) scores (-0.32 vs -0.21 for placebo, p=0.0013). The safety profile remained consistent with previous trials, with adverse events reported in 62.8% of Sotyktu patients versus 54.7% for placebo and 73.3% for apremilast.
Sotyktu, as the first TYK2 inhibitor for PsA, demonstrates potential in addressing both joint and skin symptoms. The drug is already approved in multiple countries for moderate-to-severe plaque psoriasis treatment.
Bristol Myers Squibb (NYSE: BMY) has received European Commission approval for Opdivo® plus Yervoy® as first-line treatment for adult patients with unresectable or advanced hepatocellular carcinoma (HCC).
The approval is based on the Phase 3 CheckMate -9DW trial results, which demonstrated significant survival benefits. The median overall survival was 23.7 months for Opdivo plus Yervoy compared to 20.6 months with lenvatinib or sorafenib. The combination therapy showed an impressive overall response rate of 36.1% versus 13.2% for the comparator treatments.
The approval is valid across all 27 EU member states, Iceland, Liechtenstein, and Norway. In the US, the FDA has accepted the sBLA for this combination therapy with a PDUFA date of April 21, 2025.
Bristol Myers Squibb (NYSE: BMY) has announced its latest dividend declarations. The company's Board of Directors has declared a quarterly dividend of $0.62 per share on the $0.10 par value common stock, payable on May 1, 2025, to stockholders of record as of April 4, 2025.
Additionally, the Board has declared a quarterly dividend of $0.50 per share on the company's $2.00 convertible preferred stock, which will be payable on June 2, 2025, to stockholders of record as of May 6, 2025.
Bristol Myers Squibb (NYSE: BMY) has announced its participation in two major investor conferences in March 2025. The company will engage in a fireside chat at the TD Cowen 45th Annual Health Care Conference on March 4, 2025, at 2:30 p.m. ET. Additionally, BMY will participate in another fireside chat at the Leerink Partners 2025 Global Healthcare Conference on March 12, 2025, at 11:20 a.m. ET.
Both investors and the general public are invited to listen to these sessions by visiting the company's investor relations website at http://investor.bms.com. For those unable to attend live, archived recordings of each session will be made available after their conclusion.