Bristol Myers Squibb reports news on its pharmaceutical portfolio across oncology, cardiovascular disease and immunology, including regulatory decisions, clinical trial data, commercial access programs and product collaborations. Company updates include Sotyktu (deucravacitinib), a selective TYK2 inhibitor approved in the European Union for active psoriatic arthritis, and Eliquis (apixaban), an oral anticoagulant marketed through the Bristol Myers Squibb-Pfizer alliance.
Recurring developments also cover quarterly financial results, investor conference participation, debt and capital-market activity, research collaborations in cardiovascular and precision-medicine programs, and community initiatives tied to multiple myeloma care. The company’s news flow combines product-specific regulatory milestones with broader disclosures on operating performance and pipeline partnerships.
Bristol Myers Squibb (NYSE: BMY) recently presented significant findings from its cardiovascular portfolio at the AHA Scientific Sessions 2022. Key topics included a featured presentation on CAMZYOS® (mavacamten) for obstructive hypertrophic cardiomyopathy, showcasing long-term efficacy and safety data from various studies. Highlights also included analyses of racial disparities in anticoagulant treatment among Medicare beneficiaries and pooled safety data from multiple trials. These presentations underscore the commitment to innovative cardiovascular treatments aimed at improving patient outcomes.
Bristol Myers Squibb (NYSE: BMY) announced that its Phase 3 COMMANDS trial of Reblozyl (luspatercept-aamt) achieved primary and key secondary endpoints, demonstrating significant improvement in red blood cell transfusion independence and hemoglobin levels for patients with very low, low, or intermediate-risk myelodysplastic syndromes (MDS) requiring transfusions. The safety profile remains consistent with previous studies. Detailed findings will be presented at an upcoming medical meeting as the company collaborates with health authorities for further evaluations.
Obsidian Therapeutics has announced the extension of its strategic collaboration with Bristol Myers Squibb (BMY) for the development of novel cell therapies utilizing Obsidian's cytoDRiVE® technology. This partnership, initiated in 2019, allows Bristol Myers Squibb to in-license worldwide rights for these therapies aimed at cancer treatment. Obsidian stands to gain potential milestone and royalty payments. The announcement coincides with the clinical entry of Obsidian's lead program, OBX-115, designed to improve treatment outcomes in patients with solid tumors.
Bristol Myers Squibb (NYSE: BMY) reported promising results from the Phase 3 DAYBREAK study concerning its drug Zeposia (ozanimod) for multiple sclerosis (MS). Over 90% of participants showed an immune response to COVID-19 vaccinations, all serious adverse events were absent. The study demonstrated that 68% of participants were relapse-free with an adjusted annualized relapse rate (ARR) of 0.099 after up to 74 months. These findings emphasize Zeposia's safety and efficacy, reinforcing its value in treatment options for MS.
Bristol Myers Squibb reported third quarter 2022 revenues of $11.2 billion, reflecting an 8% growth in in-line and new product sales, or 13% adjusted for foreign exchange. GAAP EPS rose 9% to $0.75, while non-GAAP EPS increased 3% to $1.99. Significant milestones include FDA approval for Sotyktu, a new psoriasis treatment, and the acquisition of Turning Point Therapeutics. The company updated its 2022 GAAP EPS guidance, primarily due to the acquisition, while reaffirming non-GAAP EPS guidance.
Bristol Myers Squibb (NYSE: BMY) announced positive results from the True North study on Zeposia (ozanimod) for ulcerative colitis (UC), highlighting its effectiveness even after treatment interruption. A significant 86.1% of patients maintained no disease relapse at Week 52, compared to 62.6% in the placebo group. Additionally, Zeposia preserved disease control for up to eight weeks post-treatment interruption. The findings were presented at the ACG 2022 meeting and support the drug's favorable profile for managing moderately to severely active UC.
Bristol Myers Squibb (NYSE: BMY) announced the FDA's acceptance of its supplemental new drug application (sNDA) for CAMZYOS® (mavacamten), aiming to expand its indication to reduce the need for septal reduction therapy (SRT) in patients with obstructive hypertrophic cardiomyopathy (HCM). The sNDA is based on the successful Phase 3 VALOR-HCM study, which met all primary and secondary endpoints with no new safety signals. The FDA has set a Prescription Drug User Fee Act goal date of June 16, 2023.
Bristol Myers Squibb (NYSE: BMY) announced significant results from the Phase 3 CheckMate -76K trial, demonstrating that Opdivo (nivolumab) as an adjuvant therapy improved recurrence-free survival (RFS) for stage IIB and IIC melanoma patients. Opdivo reduced recurrence or death risk by 58% compared to placebo (HR 0.42; p 0.0001) with 12-month RFS rates of 89% versus 79%, respectively. The safety profile was consistent with previous studies, with grade 3/4 treatment-related adverse events at 10% for Opdivo. These results highlight Opdivo's potential as a crucial treatment option for melanoma patients.
Bristol Myers Squibb (NYSE:BMY) announced changes to the dial-in and replay information for its third quarter 2022 earnings conference call set for October 26, 2022, at 8:00 a.m. ET. Investors can participate through a live webcast or by phone, with details provided for dial-in access. A replay will be available starting at 11:30 a.m. ET on the same day until November 9, 2022. The company remains focused on its mission to deliver innovative medicines for serious diseases.
Exelixis has expanded its collaboration with Bristol-Myers Squibb to include a fixed-dose combination of nivolumab and relatlimab in the ongoing phase 1b STELLAR-002 clinical trial. This trial is evaluating XL092, Exelixis' next-generation oral tyrosine kinase inhibitor (TKI), combined with immune checkpoint inhibitors for advanced solid tumors. The study aims to determine the optimal dosing regimen across various combinations, enhancing treatment options for patients.