PRINCETON, N.J. - Bristol Myers Squibb (NYSE: BMY), a pharmaceutical giant with a market capitalization of $116.28 billion and identified as a prominent player in the pharmaceuticals industry according to InvestingPro, announced today that the European Commission has sanctioned the use of Opdivo and Yervoy as a first-line treatment for adults with certain types of colorectal cancer. The company, which maintains a robust gross profit margin of 75.87%, is currently trading near its 52-week high. This approval marks a significant advancement for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC), who have limited treatment options.
The European Commission's decision is grounded on the results from the Phase 3 CheckMate -8HW trial, which demonstrated a 79% reduction in the risk of disease progression or death with the Opdivo plus Yervoy combination compared to chemotherapy. This development comes as Bristol Myers Squibb has shown strong market performance, with a remarkable 40.36% price return over the past six months. For deeper insights into BMY's valuation and growth potential, InvestingPro offers comprehensive analysis through its Pro Research Report, available among 1,400+ top stocks. The trial followed participants for a median of 31.5 months and found a median progression-free survival (PFS) that was not reached in the combination arm versus 5.9 months for chemotherapy.
The safety profile of the combination was consistent with previous findings, with no new safety concerns identified. The trial reported Grade 3/4 treatment-related adverse events in 23% of patients receiving Opdivo plus Yervoy, compared to 48% in the chemotherapy arm.
This approval extends across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. Opdivo, in combination with Yervoy, has previously been approved for multiple tumor types in the EU, but this is the first time it has been approved for mCRC in the first-line setting.
Colorectal cancer is the second leading cause of cancer death in Europe. About 5-7% of patients with metastatic colorectal cancer have MSI-H/dMMR tumors, which are less responsive to conventional chemotherapy and typically have a poorer prognosis.
Bristol Myers Squibb has expressed gratitude to the patients and investigators involved in the CheckMate -8HW clinical trial. Further data from the trial is expected to be disclosed at The American Society of Clinical Oncology Gastrointestinal Cancers Symposium scheduled for January 23-25, 2025. With annual revenue of $47.44 billion and a strong dividend yield of 4.33%, the company maintains a solid financial position in the pharmaceutical sector. InvestingPro subscribers can access 10+ additional exclusive insights about BMY's financial health and market position.
The information in this article is based on a press release statement from Bristol Myers Squibb.
In other recent news, Bristol-Myers Squibb (NYSE:BMY) reported third-quarter earnings that exceeded expectations, leading Bernstein SocGen Group and BMO Capital to raise the company's price target. However, CFRA downgraded Bristol Myers Squibb shares from Buy to Hold, despite the company's strong market position following the U.S. approval of Cobenfy for the treatment of schizophrenia in adults. The European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Bristol Myers Squibb's drug, repotrectinib, for the treatment of ROS1-positive advanced non-small cell lung cancer and certain advanced solid tumors. This recommendation follows positive outcomes from the TRIDENT-1 and CARE clinical trials.
Bristol Myers Squibb's recent acquisition of Karuna Therapeutics (NASDAQ:KRTX) is aimed at enhancing long-term growth with ongoing trials in schizophrenia and Alzheimer's. The company also plans to initiate three Phase 3 studies in 2024 and present Phase 1 data for CD19 NEX-T cell therapy.
JPMorgan maintains its Overweight rating on Bristol-Myers Squibb, highlighting the company's promising developments, particularly the launch of Cobenfy for schizophrenia treatment. Bristol Myers Squibb has also announced a dividend increase to $0.62 per share, marking the 16th consecutive year of dividend increases. These are all recent developments.
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