tiprankstipranks
Market News

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. 

Investors 

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.

Download the TipRanks mobile app now 

To find good ideas for stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights. 

Read full Disclaimer & Disclosure 

Related News: 
Lennar Posts Strong Quarterly Results as Housing Market Outperforms 
FDA Clears Investigational NDA for Sonnet’s SON-1010; Shares Skyrocket 
Starbucks’ CEO Steps Down; Shares Gain Over 5%

Tired of arriving late to the Big Returns Party?​
Most investors don’t have major gainers like TSLA or NVDA on their radar from the start.
The profusion of opinions on social media and financial blogs makes it impossible to distinguish between real growth potential and pure hype.
​​For the past decade, we have developed and perfected technology designed to help private investors, just like you, find the best opportunities, with the greatest upside potential, in any financial climate.​
Learn More