Bristol Myers Squibb (NYSE: BMY), a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved its therapy Opdualag (nivolumab and relatlimab-rmbw) under its Real-Time Oncology Review (RTOR) pilot program.
Opdualag is a first-of-its-kind, fixed-dose dual immunotherapy treatment through the combination of the programmed death-1 (PD-1) inhibitor nivolumab and lymphocyte activation gene-3 (LAG-3)-blocking antibody relatlimab. It is designed to treat adults and pediatric patients aged 12 years or older with metastatic melanoma, a form of skin cancer.
The U.S. regulator’s decision was based on results from the Phase 2/3 RELATIVITY-047 trial, which is designed to compare Opdualag to nivolumab alone in patients with previously undiagnosed metastatic melanoma. The trial met its primary endpoint, progression-free survival (PFS), and Opdualag demonstrated significantly higher PFS when compared to nivolumab monotherapy. Additionally, no new safety events were revealed.
Bristol Myers Squibb CMO Samit Hirawat said, “Inhibiting LAG-3 with relatlimab, in a fixed-dose combination with nivolumab, represents a new treatment approach that builds on our legacy of bringing innovative immunotherapy options to patients.”
Wall Street’s Take
Recently, BMO Capital analyst Evan Seigerman reiterated a Buy rating and a price target of $74 on the stock. This indicates a 4.2% upside potential from Friday’s closing price of $71.02 per share.
Shares of Bristol Myers Squibb have rallied 15.71% over the past year, while the stock still scores a Strong Buy consensus rating, based on six Buys and one Hold. That’s alongside an average Bristol Myers Squibb price target of $72.83, which implies 2.55% upside potential to current levels.
TipRanks’ Stock Investors tool shows that investors currently have a Very Positive stance on Bristol Myers Squibb, with 4.8% of investors maintaining portfolios on TipRanks increasing their exposure to BMY stock over the past 30 days.
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