Bristol-Myers Squibb Co. - BMY STOCK NEWS

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.

Repertoire® Immune Medicines has announced a multi-year strategic collaboration with Bristol Myers Squibb (BMY) to develop tolerizing vaccines for up to three autoimmune diseases. As part of the agreement, Repertoire will receive an upfront payment of $65 million and is eligible to receive up to $1.8 billion for achieving development, regulatory, and commercial milestones, in addition to receiving tiered royalties. The collaboration aims to develop efficacious, selective, and durable treatments for patients suffering from autoimmune disease by resetting the immune system. Repertoire will lead all activities through development candidate nomination, while BMS will lead clinical development, regulatory affairs, and commercialization of the tolerizing vaccines under an exclusive worldwide license. The collaboration combines Repertoire's leading DECODE™ platform with BMS's expertise in developing and commercializing innovative immune medicines.

The CHMP adopts a positive opinion recommending the approval of Bristol Myers Squibb's Opdivo in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. If approved, this regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU. The decision on EU marketing authorization is expected by June 2024.