Bristol-Myers Squibb Co. - BMY STOCK NEWS

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.

Bristol Myers Squibb (NYSE: BMY) announced that the U.S. FDA has granted accelerated approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed CAR T cell therapy, for adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. The approval is based on response rate and duration of response from the Phase 2 TRANSCEND FL trial, where 95.7% of patients responded, with a median duration of response not reached.

The majority (77.1%) of responders were still in response at 18 months. Breyanzi offers a consistent safety profile and can be administered both inpatient and outpatient. The drug is also included in the NCCN Guidelines for B-cell lymphomas as a Category 2A recommendation for third-line and subsequent therapy for relapsed or refractory FL.

Common adverse events include cytokine release syndrome (53% of patients) and neurologic toxicities (31% of patients). Bristol Myers Squibb's programs support patient access and treatment experience.

Bristol Myers Squibb announced that the Phase 3 CheckMate -73L trial did not meet its primary endpoint of progression-free survival in unresectable, locally advanced stage III non-small cell lung cancer. The trial evaluated Opdivo with concurrent chemoradiotherapy followed by Opdivo plus Yervoy versus CCRT followed by durvalumab. The adverse events observed were consistent with known profiles. The company plans to evaluate the data further to inform future drug development efforts.

Bristol Myers Squibb (BMY) will participate in investor conferences in May 2024. Ben Hickey and David Elkins will engage in fireside chats at separate events, addressing questions about the company. Both sessions are open to investors and the public via the company's investor website.

Bristol Myers Squibb's application for Opdivo plus Yervoy for the first-line treatment of adult patients with MSI-H/dMMR metastatic colorectal cancer has been validated by the European Medicines Agency. The submission is based on positive results from the CheckMate -8HW study, demonstrating significant improvement in progression-free survival compared to chemotherapy.

Bristol Myers Squibb's application for the subcutaneous formulation of Opdivo (nivolumab) has been accepted by the FDA, with a target action date of February 28, 2025. This application is based on results from the CheckMate -67T Phase 3 trial, which demonstrated noninferior pharmacokinetics, efficacy, and safety of the subcutaneous formulation versus the intravenous formulation. Subcutaneous nivolumab has the potential to be the first subcutaneously administered PD-1 inhibitor.

Scenic Biotech has partnered with Bristol Myers Squibb to utilize its Cell-Seq technology platform in accelerating drug target development. The collaboration involves an upfront payment and potential additional payments tied to research, development, and commercial milestones. This marks Scenic Biotech's second strategic collaboration with a major industry player, showcasing the value of its groundbreaking approach in supporting the creation of innovative medicines.