Bristol-Myers Squibb Co Stock Price, News & Analysis

Bristol Myers Squibb announced that the Phase 3 CheckMate -901 trial did not meet its primary endpoint of overall survival for Opdivo plus Yervoy in treating patients with metastatic urothelial carcinoma expressing PD-L1 ≥1%. Despite this, the trial continues under the guidance of an independent Data Monitoring Committee to explore other endpoints, and no new safety signals were observed. The company emphasizes its commitment to advancing research in urothelial carcinoma and looks forward to future data from ongoing studies.

Bristol Myers Squibb (NYSE: BMY) has announced the planned sale of its East Syracuse, New York manufacturing facility to LOTTE Corporation, marking a strategic move in its manufacturing network. This transaction, expected to close in the second half of 2022 pending regulatory approvals, will result in LOTTE establishing the site as its North American operations center for biologics contract development and manufacturing. The site, notable for its commercial-scale production capabilities, will continue to support BMY until the completion of the deal.

Bristol Myers Squibb (NYSE: BMY) announced positive results from the POETYK PSO long-term extension trial, revealing that the efficacy of deucravacitinib is maintained for up to two years in patients with moderate to severe plaque psoriasis. The trial showed response rates of 77.7% for PASI 75 and 58.7% for sPGA 0/1 after 60 weeks. Deucravacitinib, currently under regulatory review in the U.S., Europe, and Japan, is positioned to be the first selective TYK2 inhibitor approved for any disease. The safety profile remained consistent, with low incidence of serious adverse events.

Bristol Myers Squibb (NYSE: BMY) will participate in a fireside chat at the Bank of America Securities 2022 Healthcare Conference on May 11, 2022, in Las Vegas, Nevada. Adam Lenkowsky, Senior Vice President and General Manager, U.S. Commercialization, will address questions at 12:00 p.m. PT (3:00 p.m. ET). The session will be available via a live webcast on the company's investor relations website. An archived version will be accessible later that day. For further details, visit BMS.com.

Bristol Myers Squibb (NYSE:BMY) reported Q1 2022 revenues of $11.6 billion, a 5% increase year-over-year, driven by strong sales from in-line products like Eliquis and Opdivo. Earnings per share (EPS) stood at $0.59 (down 34% YoY), while non-GAAP EPS rose 13% to $1.96. The company achieved FDA approvals for Opdualag and Camzyos, expanding its portfolio. However, guidance adjustments reflected pressures from recent LOE products like Revlimid.

Bristol Myers Squibb (NYSE: BMY) announced that the FDA approved Camzyos (mavacamten) for adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). This approval follows the successful Phase 3 EXPLORER-HCM trial, where 37% of patients achieved significant health improvements. Camzyos is the first cardiac myosin inhibitor targeting the disease's underlying mechanisms, offering a new treatment option.

However, it comes with a Boxed Warning for heart failure risks, necessitating ongoing monitoring of left ventricular ejection fraction (LVEF) during treatment.

Nektar Therapeutics (NKTR) and Bristol Myers Squibb (BMY) announced the discontinuation of the global clinical development program for bempegaldesleukin in combination with Opdivo after late-stage studies failed to show clinical benefit in renal cell carcinoma and bladder cancer. In the Phase 3 PIVOT-09 study, bempegaldesleukin did not meet the criteria for statistical significance compared to the TKI control arm. The separate Phase 2 PIVOT-10 study also lacked sufficient efficacy. All related studies will be terminated, allowing patients to pursue standard treatment options.

Bristol Myers Squibb announced the Phase 3 CheckMate -816 trial results, showing that Opdivo (nivolumab) combined with chemotherapy significantly improved event-free survival (EFS) for resectable non-small cell lung cancer (NSCLC). Administering three cycles of Opdivo before surgery reduced the recurrence, progression, or death risk by 37%. The median EFS was 31.6 months for the combination compared to 20.8 months for chemotherapy alone. Opdivo received FDA approval for this neoadjuvant treatment based on these findings. Early overall survival trends were also promising, with 83% alive at two years.

Bristol Myers Squibb has received Marketing Authorization from the European Commission for Breyanzi (lisocabtagene maraleucel), a CAR T cell therapy designed for adults with relapsed or refractory large B-cell lymphoma. This approval is based on outcomes from the TRANSCEND trials, demonstrating a 73% response rate and a manageable safety profile. The approval marks the company's second CAR T therapy in the EU, expanding treatment options for patients facing limited choices. Breyanzi aims to address unmet medical needs in this patient population.