Pharmaceutical companies Bristol Myers Squibb (NYSE:BMY) and 2seventy bio (TSVT) are down in trading at the time of writing. This comes after announcing that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) will meet to discuss data supporting the supplemental Biologics License Application (sBLA) for its multiple myeloma therapy Abecma (idecabtagene vicleucel) from its Phase 3 KarMMa-3 study.
The company stated that the FDA has not yet confirmed the date of the meeting but 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.”
The companies anticipate that the “committee will review data related to the secondary endpoint of overall survival (OS).” The companies intend to continue discussions with the FDA and participate in the ODAC meeting.
BMY added that the Phase 3 KarMMa-3 study was a pivotal, open-label, global, randomized, and controlled trial that met its primary endpoint.
What is the Future of BMY Stock?
Analysts remain cautiously optimistic about BMY stock with a Moderate Buy consensus rating based on six Buys, 10 Holds, and one Sell. BMY stock has slid by more than 25% year-to-date and the average BMY price target of $60.69 implies an upside potential of 19.4% at current levels.