Bristol-Myers Squibb Co. - BMY STOCK NEWS

Bristol Myers Squibb announced European Commission approval for Opdivo® (nivolumab) combined with cisplatin and gemcitabine for first-line treatment of unresectable or metastatic urothelial carcinoma (UC). The approval was based on the CheckMate -901 Phase 3 trial, which demonstrated that the combination improved overall survival and progression-free survival compared to chemotherapy alone.

Results from the trial showed a 22% reduction in the risk of death and a 28% reduction in the risk of disease progression or death. The combination also resulted in a higher overall response rate of 57.6% versus 43.1% with chemotherapy alone. These findings position Opdivo with chemotherapy as a new standard of care for this patient population in the EU.

Serious adverse reactions affected 48% of patients, with common side effects including nausea, fatigue, and musculoskeletal pain. The combination treatment has been approved for use in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.

Bristol Myers Squibb (BMS) has announced a 10-year initiative called ASPIRE to address health inequities in low- and middle-income countries (LMICs). The ASPIRE strategy, which stands for Accessibility, Sustainability, Patient-centric, Impact, Responsibility and Equity, aims to reach over 208,000 patients in LMICs by 2033. BMS is collaborating with the Access to Oncology Medicines (ATOM) Coalition to make Opdivo™ (nivolumab) available in select LMICs, including Pakistan, Rwanda, and Zambia, by 2026. This initiative focuses on improving access to immuno-oncology therapies and strengthening health systems, aligning with BMS's commitment to global health equity and their Environmental, Social, and Governance (ESG) strategy.

Bristol Myers Squibb (NYSE: BMY) will present data from over 130 studies on approximately 25 cancer types and blood disorders at the 2024 ASCO and EHA meetings. Highlights include pivotal data on KRAZATI® (adagrasib) for KRASG12C-mutant NSCLC, and CheckMate -9DW trial results on Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for advanced hepatocellular carcinoma. Long-term data for Opdualag™, Opdivo, and Breyanzi® (lisocabtagene maraleucel) will be showcased, highlighting sustained clinical outcomes. Emerging science includes efficacy and safety data for new treatments like the triplet combination of nivolumab, relatlimab, and ipilimumab for advanced melanoma, and the first results of GPRC5D-directed CAR T cell therapy for multiple myeloma. The comprehensive data reflect Bristol Myers Squibb’s commitment to advancing immuno-oncology, targeted therapies, and novel treatment modalities.

Bristol Myers Squibb (NYSE: BMY) announced data presentation at the 2024 American Society of Clinical Psychopharmacology Annual Meeting, highlighting the potential of KarXT as a novel treatment for schizophrenia. The EMERGENT-5 trial showed no significant changes in movement disorder scale scores and a low 1% incidence of treatment-related extrapyramidal symptoms (EPS). Participants reported improvements in positive, negative, and cognitive symptoms of schizophrenia.

Notable findings will include data on the low long-term risk of EPS and participant experiences with KarXT, emphasizing its safety and efficacy. Bristol Myers Squibb anticipates continuing discussions with the U.S. FDA on KarXT's potential approval.

Bristol Myers Squibb (BMY) unveiled a 10-year strategy named ASPIRE to expand access to its innovative treatments in low- and middle-income countries (LMICs). The strategy aims to reach over 200,000 patients by 2033. ASPIRE focuses on affordability and availability, ensuring 100% of BMY's marketed products have access plans. BMY is also using local brands and pathways like Direct Import and Direct-to-Institution to enhance access in LMICs. Additionally, BMY is collaborating with the Access to Oncology Medicines (ATOM) Coalition to provide Opdivo™ in select countries. The initiative aligns with BMY's commitment to health equity and its Environmental, Social, and Governance (ESG) strategy.

NeoPhore announced that Bristol Myers Squibb (NYSE: BMY) has joined its oversubscribed Series B extension round. The additional funding will enable NeoPhore to explore novel biology associated with the DNA mismatch repair (MMR) pathway in cancer and advance its lead program to candidate selection by 2025. NeoPhore targets the MMR pathway to develop next-generation immuno-oncology therapeutics. The funding strengthens NeoPhore's position in pre-clinical studies, aiming to deliver a candidate drug for its lead PMS2 program. The announcement underscores NeoPhore’s approach to inducing neoantigen expression and immunogenicity in solid tumors.

Bristol Myers Squibb (BMY) has announced the launch of the 'Live Your PosSCZible' campaign in partnership with the schizophrenia community. This national initiative aims to elevate the voices of those with schizophrenia and their care partners to foster meaningful conversations and reduce stigma. The campaign features actor Taye Diggs and his sister, Christian, who was diagnosed with schizophrenia as a young adult. They share their experiences to highlight that with proper treatment and support, people with schizophrenia can achieve their ambitions. The campaign provides resources and tools to enhance understanding and empathy, and it includes various stories and videos from the schizophrenia community. These resources are available on LiveYourPosSCZible.com and across social media platforms.

Bristol Myers Squibb announced an updated Prescription Drug User Fee Act (PDUFA) goal date of December 29, 2024, for the FDA's decision on the subcutaneous formulation of Opdivo® (nivolumab) combined with Halozyme's rHuPH20. This formulation is under evaluation from the CheckMate -67T Phase 3 trial, which aims to demonstrate its noninferior pharmacokinetics, efficacy, and safety compared to intravenous Opdivo. The trial includes patients with advanced or metastatic clear cell renal cell carcinoma who have undergone prior systemic therapy. If approved, subcutaneous nivolumab could become the first subcutaneously administered PD-1 inhibitor.

Bristol Myers Squibb (NYSE:BMY) announced new four-year data from the POETYK PSO long-term extension trial of Sotyktu (deucravacitinib) in adults with moderate-to-severe plaque psoriasis. After four years, 71.7% of patients achieved a Psoriasis Area and Severity Index (PASI) 75 response, 47.5% achieved PASI 90, and 57.2% achieved a static Physician's Global Assessment (sPGA) 0/1. The safety profile remained consistent with no new safety signals. These results were presented at the European Academy of Dermatology and Venereology Spring Symposium in Malta, May 16-18, 2024. The trial included 1,519 patients, with 4,392.8 patient-years of cumulative exposure. Adverse event rates decreased or remained stable over four years, highlighting Sotyktu's potential as an oral standard of care for plaque psoriasis.