Bristol-Myers Squibb Co. - $BMY STOCK NEWS

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.

Bristol Myers Squibb reported first quarter financial results for 2024, showcasing a 5% increase in revenues to $11.9 billion. Key achievements include U.S. approval of Abecma and Breyanzi, positive proof of concept for Opdualag, and strategic cost-saving initiatives. Despite a GAAP loss per share of $(5.89), the non-GAAP loss per share was $(4.40). The company aims to reinvest cost savings to fuel innovation and growth.

Bristol Myers Squibb and Cellares have entered into a $380M worldwide capacity reservation and supply agreement for the manufacture of CAR T cell therapies. Cellares will provide its Cell Shuttle platform for Bristol Myers Squibb's clinical and commercial-scale manufacturing needs, enhancing agility, scalability, and turnaround time. This collaboration aims to bring the promise of cell therapies to more patients faster.

Bristol Myers Squibb (BMY) focuses on advancing patient health globally and enhancing ESG performance. The company aims to address health inequities, expand access to medicines in LMICs, and reduce environmental impact.

Bristol Myers Squibb presents promising data on KRAZATI (adagrasib) in combination with cetuximab for KRASG12C-mutated colorectal cancer at AACR annual meeting. The study shows an objective response rate of 34%, with a median progression-free survival of 6.9 months and median overall survival of 15.9 months. Disease control was observed in 85% of patients, highlighting the potential of adagrasib for this specific patient group.