Bristol-Myers Squibb Co Stock Price, News & Analysis

Bristol Myers Squibb (NYSE:BMY) presented key data on Zeposia (ozanimod) for ulcerative colitis at the virtual Digestive Disease Week® (DDW) from May 21-23, 2021. Oral presentations highlighted its long-term safety and efficacy, showing improvements in clinical symptoms and remission rates. Notably, Zeposia demonstrated a consistent safety profile and increased likelihood of corticosteroid-free remission at Week 52. Mary Beth Harler emphasized the drug's potential to meet the needs of patients with gastrointestinal diseases and the company's ongoing commitment to further research.

Bristol Myers Squibb (NYSE: BMY) announced that the European Medicines Agency's CHMP recommended approval of Opdivo (nivolumab) with Yervoy (ipilimumab) for adults with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) after prior chemotherapy. This decision stemmed from the Phase 2 CheckMate -142 trial. The European Commission will review this recommendation. This combination has previously received FDA approval in July 2018 and Japan in September 2020, highlighting its significance in addressing a critical treatment gap.

Bristol Myers Squibb (NYSE: BMY) announced FDA approval for Opdivo® (nivolumab) as an adjuvant treatment for completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual disease post-neoadjuvant chemoradiotherapy. The approval follows the CheckMate -577 trial, showing a median disease-free survival of 22.4 months for Opdivo versus 11.0 months for placebo, indicating a 31% reduction in recurrence risk. This approval represents a significant advancement in treatment options for aggressive cancer types.

Bristol Myers Squibb (NYSE: BMY) has elected Dr. Manuel Hidalgo Medina to its Board of Directors, effective June 1, 2021. Dr. Hidalgo, a prominent figure in oncology, is currently the chief of hematology and medical oncology at Weill Cornell Medicine. His extensive experience in anticancer drug development, particularly in gastrointestinal cancers, is expected to enhance the company's scientific leadership. The board's size will increase to 11 members with his election, aimed at advancing Bristol Myers Squibb's long-term strategy in innovative medicine.

Bristol Myers Squibb (NYSE: BMY) announced that in the Phase 3 CheckMate -9LA trial, the combination of Opdivo and Yervoy with two cycles of chemotherapy resulted in a significant survival benefit for patients with advanced non-small cell lung cancer (NSCLC). After two years, 38% of patients on the combination therapy were alive compared to 26% receiving chemotherapy alone. Median overall survival was 15.8 months for the combination versus 11.0 months for chemotherapy. Safety profiles were consistent with previous studies, and secondary endpoints showed improved progression-free survival and overall response rates.

Bristol Myers Squibb (NYSE: BMY) announced positive long-term survival data from the Phase 3 CheckMate -227 trial comparing the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) against chemotherapy in patients with advanced non-small cell lung cancer (NSCLC). With a follow-up of 49.4 months, the four-year survival rates were 29% for the combination therapy versus 18% for chemotherapy in patients with PD-L1 expression ≥1%. The dual therapy demonstrated improved survival across various PD-L1 expression levels, affirming its potential as a first-line option against NSCLC.

Bristol Myers Squibb (NYSE: BMY) presented six-and-a-half-year results from the CheckMate -067 trial, showing significant survival benefits for patients with advanced melanoma treated with Opdivo (nivolumab) plus Yervoy (ipilimumab). The median overall survival was reported at 72.1 months for the combination therapy, the longest in a Phase 3 trial for this condition. Progression-free survival rates were 34% for the combination, compared to 29% and 7% for Opdivo and Yervoy alone, respectively. Safety profiles remained consistent with past studies, indicating sustained benefits of the treatment regimen.

Bristol Myers Squibb (BMY) and bluebird bio (BLUE) revealed new findings from the pivotal KarMMa study on Abecma (idecabtagene vicleucel), a CAR T cell therapy for multiple myeloma. Updated results show a consistent overall response rate of 73% and a complete response in 33% of patients after a median follow-up of 24.8 months. The safety profile indicates common adverse events include cytopenias (97%) and cytokine release syndrome (84%). Abecma remains the first BCMA-directed CAR T therapy approved by the FDA, with ongoing reviews in other regions.

Bristol Myers Squibb (NYSE: BMY) announced promising results from the Phase 2/3 RELATIVITY-047 trial, demonstrating that the combination of relatlimab and nivolumab significantly improved progression-free survival (PFS) in patients with untreated metastatic melanoma compared to Opdivo alone. The median PFS was 10.12 months for the combination versus 4.63 months for Opdivo (p=0.0055). This regimen is the first to show a statistical benefit over anti-PD-1 therapy in this patient group. The safety profile was consistent with previous studies, highlighting its potential as a new treatment option.