CymaBay Announces FDA Accepted NDA For Seladelpar For Primary Biliary Cholangitis; FDA Grants Priority Review
Portfolio Pulse from Benzinga Newsdesk
CymaBay Therapeutics announced that the FDA has accepted its New Drug Application (NDA) for Seladelpar, aimed at treating Primary Biliary Cholangitis, and has granted it Priority Review status. The target Prescription Drug User Fee Act (PDUFA) date is set for August 14.
February 12, 2024 | 1:47 pm
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CymaBay's Seladelpar NDA for Primary Biliary Cholangitis has been accepted by the FDA, with Priority Review status. The PDUFA date is August 14.
The acceptance of the NDA for Seladelpar by the FDA, especially with Priority Review status, is a significant positive development for CymaBay. This status not only highlights the potential of Seladelpar as a treatment for Primary Biliary Cholangitis but also accelerates the review process, potentially leading to a faster market entry. Given the importance of Seladelpar to CymaBay's product pipeline, this news is likely to be viewed positively by investors, potentially leading to an increase in stock price in the short term.
CONFIDENCE 90
IMPORTANCE 95
RELEVANCE 100