Bristol-Myers Squibb Co Stock Price, News & Analysis

Bristol Myers Squibb (NYSE:BMY) has announced that the U.S. Food and Drug Administration (FDA) has approved Orencia^® (abatacept) for preventing acute graft versus host disease (aGvHD) in patients receiving hematopoietic stem cell transplants. This marks the fourth FDA indication for Orencia, which is already established in treating several rheumatic diseases. The approval is particularly significant given the higher risk of aGvHD in racial and ethnic minority populations due to challenges in finding matched donors.

Exelixis, Inc. has initiated the dose-escalation stage of the STELLAR-002 trial, exploring XL092, a next-generation tyrosine kinase inhibitor, in combination with immuno-oncology therapies for advanced cancers. Collaborating with Bristol-Myers Squibb and Nektar Therapeutics, the trial aims to assess safety and efficacy among patients with advanced solid tumors. The study will focus on renal cell carcinoma, urothelial carcinoma, and metastatic castration-resistant prostate cancer, with primary endpoints including objective response rates and progression-free survival.

Bristol Myers Squibb (BMY) has secured a global exclusive license to Immatics' (IMTX) TCR bispecific program IMA401. This strategic collaboration involves an upfront payment of $150 million to Immatics, alongside potential milestone payments totaling $770 million and tiered double-digit royalties on net sales. IMA401 targets MAGEA4/8 antigens prevalent in solid tumors and has shown promising preclinical anti-tumor activity. The clinical trial is expected to start in the first half of 2022, enhancing both companies' oncology portfolios.

Bristol Myers Squibb (NYSE: BMY) announced on December 10, 2021, a 10.2% increase in its quarterly dividend to $0.54 per share, marking the thirteenth consecutive fiscal year of dividend growth. The increase, effective February 1, 2022, reflects the company's strong financial position and commitment to shareholder returns. Additionally, the Board approved a $15 billion multi-year share repurchase program, bringing total repurchase authorization to approximately $15.2 billion, allowing management flexibility based on market conditions.

Bristol Myers Squibb (NYSE: BMY) announced that Breyanzi significantly improved event-free survival (EFS) compared to standard chemotherapy in the Phase 3 TRANSFORM study for relapsed or refractory large B-cell lymphoma (LBCL). The trial showed a median EFS of 10.1 months for Breyanzi versus 2.3 months for chemotherapy, representing a 65% reduction in risk of events. Breyanzi also demonstrated a manageable safety profile with low rates of severe adverse events. The findings were disclosed at the ASH Annual Meeting, marking a potential shift in treatment standards.

Bristol Myers Squibb (NYSE: BMY) announced that the FDA has accepted for priority review the supplemental Biologics License Application for Reblozyl (luspatercept-aamt) to treat anemia in adults with non-transfusion dependent beta thalassemia, with a PDUFA goal date of March 27, 2022. The application is based on Phase 2 BEYOND study results. Additionally, the European Medicines Agency has validated the Type II variation for Reblozyl in this indication. The BEYOND study involved 145 patients, aimed at assessing efficacy and safety.

Bristol Myers Squibb (NYSE: BMY) announced the acceptance of its New Drug Application (NDA) for deucravacitinib, an oral selective tyrosine kinase 2 (TYK2) inhibitor, by the U.S. Food and Drug Administration (FDA) and validation from the European Medicines Agency (EMA) for treating adults with moderate to severe plaque psoriasis. The pivotal Phase 3 POETYK-PSO trials indicate deucravacitinib's superior efficacy compared to Otezla (apremilast) and placebo. A PDUFA goal date of September 10, 2022 has been assigned by the FDA.

Bristol Myers Squibb (NYSE:BMY) has received European Commission approval for Zeposia (ozanimod) as a treatment for adults with moderately to severely active ulcerative colitis (UC). This marks Zeposia as the first oral S1P receptor modulator for UC, providing a new treatment option for patients unresponsive to conventional therapies. The approval is based on the Phase 3 True North trial, demonstrating significant clinical benefits, including increased remission rates and no new safety concerns.

Bristol Myers Squibb (NYSE: BMY) announced that the FDA has extended the review of its New Drug Application for mavacamten, intended for treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM), to April 28, 2022. This extension, notified on November 18, 2021, allows more time for assessing the updated Risk Evaluation Mitigation Strategy. No additional data or studies are required. The company maintains confidence in mavacamten's profile, citing positive results in the pivotal EXPLORER-HCM trial, which highlighted improvements in symptoms and quality of life for patients.