Why Is Pharma Giant Bristol-Myers Squibb Stock Trading Lower Today?

Shares of Bristol-Myers Squibb Company BMY and  2seventy Bio Inc TSVT fell after the companies' efforts to win expanded U.S. approval for its Abecma gene therapy hit a delay.

The FDA's Oncologic Drugs Advisory Committee (ODAC) will meet to review data supporting the supplemental Biologics License Application (sBLA) for Abecma (idecabtagene vicleucel) for earlier lines of triple-class exposed relapsed or refractory multiple myeloma (RRMM) based on results from the pivotal Phase 3 KarMMa-3 study. 

Also Read: 2seventy Bio's Cost Cuts Prudent, But Analyst Says It Induces Lower Confidence In Lead Product.

The FDA has not yet confirmed the date of the ODAC meeting. The FDA also informed the companies that a decision on the application will not be made by the Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2023.

Abecma is currently approved for adults with triple-class exposed RRMM after four or more prior lines of therapy.

Abecma generated $69 million U.S. commercial revenue in Q3 FY23 and $302 million U.S. commercial revenue year-to-date.

The KarMMa-3 study met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival compared to standard regimens, significantly reducing the risk of disease progression or death versus standard regimens.

Price Action: TSVT stock is down 20.65% at $1.65, and BMY shares are down 2.75% at $49.44 on the last check Monday.

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