Bristol-Myers Squibb Co Stock Price, News & Analysis

Bristol Myers Squibb (NYSE: BMY) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its drug CAMZYOS (mavacamten), intended for treating symptomatic obstructive hypertrophic cardiomyopathy (HCM) in adults. CAMZYOS would be the first cardiac myosin inhibitor in Europe targeting the source of obstructive HCM. The recommendation follows successful results from the Phase 3 EXPLORER-HCM and VALOR-HCM trials, which demonstrated significant benefits over placebo. The European Commission will now review the CHMP's opinion. CAMZYOS is already approved in the U.S., Australia, Canada, Brazil, and Switzerland, marking a significant step for Bristol Myers Squibb in offering innovative cardiovascular treatments.

Bristol Myers Squibb (NYSE: BMY) announced the expansion of its global cell therapy manufacturing network with the addition of in-house viral vector production capabilities at its Libertyville, Illinois facility. This development follows an agreement with Novartis to enhance the company's operations, specifically for its CAR T cell therapies. The new facility aims to address the increasing demand for viral vectors, crucial for engineering T cells for infusion therapies, thereby enabling more patients to access these treatments. The transition of the Libertyville site to Bristol Myers Squibb is expected to occur throughout 2023, supporting the company’s long-term ambitions in cell therapy.

Bristol Myers Squibb (BMY) has entered into a strategic license agreement with Tubulis to develop differentiated antibody-drug conjugates (ADCs) for cancer treatment. BMY will pay Tubulis an upfront fee of $22.75 million, with potential milestone payments exceeding $1 billion and tiered royalties on net sales. This partnership allows BMY access to Tubulis’ proprietary P5 conjugation and Tubutecan platforms, enhancing their capability in ADC development. The agreement highlights BMY's focus on oncology and the therapeutic potential of ADCs, addressing the need for innovative cancer treatments. Tubulis aims to leverage its technologies to create ADCs that reduce unwanted side effects while effectively delivering therapies to solid tumors.

The U.S. FDA has accepted the supplemental Biologics License Application (sBLA) for Bristol Myers Squibb (NYSE:BMY) and 2seventy bio's Abecma (idecabtagene vicleucel), with a target action date set for December 16, 2023. This application is based on promising interim results from the Phase 3 KarMMa-3 study, which demonstrated a significant reduction in disease progression or death for patients with relapsed and refractory multiple myeloma compared to standard treatments. Additionally, the European Medicines Agency validated a Type II variation application for Abecma, and Japan's Ministry of Health accepted the supplemental New Drug Application. These developments highlight the commitment to enhance treatment options for multiple myeloma patients.

Bristol Myers Squibb (NYSE: BMY) has expanded its collaboration with Foundation Medicine to develop the FoundationOne CDx as a companion diagnostic for its investigational tyrosine kinase inhibitor, repotrectinib. This drug is currently under evaluation in the TRIDENT-1 Phase 1/2 trial for patients with ROS1+ non-small cell lung cancer (NSCLC) and NTRK+ solid tumors. If successful, the FoundationOne CDx will help identify suitable patients for treatment with repotrectinib. Foundation Medicine leads in the U.S. with approximately 60% of all companion diagnostic approvals for next-generation sequencing (NGS) testing, enhancing personalized treatment options.

Bristol Myers Squibb has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for Breyanzi, aimed at treating adult patients with diffuse large B-cell lymphoma and related conditions who relapse within 12 months after first-line therapy. This endorsement is based on the pivotal Phase 3 TRANSFORM study results, which showcased Breyanzi's efficacy as a second-line treatment compared to conventional methods. The European Commission's final decision is expected within two months. This milestone underscores a new potential standard of care in a critical unmet need for many patients.

Bristol Myers Squibb (BMY) reported three-year follow-up results from the Phase 3 CheckMate -816 trial at ELCC 2023, highlighting significant clinical benefits of neoadjuvant Opdivo (nivolumab) combined with chemotherapy in non-small cell lung cancer (NSCLC). The combination therapy reduced the risk of disease recurrence, progression, or death by 32%, achieving a 57% event-free survival (EFS) rate compared to 43% with chemotherapy alone. Time to distant metastasis or death was also improved, with rates of 71% vs. 50%. Although overall survival data remains immature, a favorable trend was observed, with 78% of patients alive at three years versus 64% with chemotherapy.

Bristol Myers Squibb (NYSE:BMY) announced the European Commission's approval of Sotyktu (deucravacitinib), a first-in-class oral therapy for moderate-to-severe plaque psoriasis. The approval is based on pivotal Phase 3 trials (POETYK PSO-1 and POETYK PSO-2), which demonstrated Sotyktu's superior efficacy over both placebo and Otezla at 16 and 24 weeks, with sustained responses at 52 weeks. Notably, the therapy presents a favorable safety profile. With approximately 14 million people affected by psoriasis in Europe, Sotyktu addresses an urgent need for accessible and effective treatments in this patient population.

CHARM Therapeutics has announced a strategic collaboration with Bristol Myers Squibb (BMY) to utilize its DragonFold deep learning platform for discovering and optimizing compounds against selected targets. CHARM will lead early discovery efforts, while BMY retains the option to license developed compounds. The agreement includes an upfront payment and potential future payments, which enhance CHARM's financial runway. This collaboration aims to accelerate the development of new medicines addressing difficult-to-target diseases, reinforcing BMY's commitment to innovative treatments.