FDA Approves Bristol Myers Squibb’s Opdualag Therapy
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FDA Approves Bristol Myers Squibb’s Opdualag Therapy

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. 

Supporting Data 

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.  

Official Comments 

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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