Bristol-Myers Squibb Co Stock Price, News & Analysis

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 An archived version will be accessible later that day.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.

Bristol Myers Squibb has announced that the European Commission has approved Opdivo (nivolumab) combined with chemotherapy as a first-line treatment for adults with unresectable advanced esophageal squamous cell carcinoma (ESCC) with PD-L1 expression ≥ 1%. This approval is based on the Phase 3 CheckMate -648 trial, which showed a median overall survival of 15.44 months for Opdivo plus chemotherapy versus 9.07 months for chemotherapy alone. The safety profile aligns with previous studies, marking a significant advancement for patients in the EU.

Bristol Myers Squibb has received European Commission approval for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment for adults with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) with PD-L1 expression ≥ 1%. The approval follows results from the Phase 3 CheckMate-648 trial, highlighting a median overall survival of 13.70 months for patients treated with Opdivo plus Yervoy, compared to 9.07 months with chemotherapy. This treatment is now available in the EU, Iceland, Liechtenstein, and Norway.

Bristol Myers Squibb announced that the European Commission approved Opdivo (nivolumab) for adjuvant treatment of adults with muscle-invasive urothelial carcinoma, marking it as the first immunotherapy option approved in this setting in the EU. The approval is based on Phase 3 CheckMate -274 trial results, showing a 47% reduction in the risk of disease recurrence or death for patients with PD-L1 expression ≥1%, compared to placebo. Opdivo has now received EU approvals for three cancer types, enhancing its position in cancer treatment.