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CymaBay Announces FDA Acceptance Of NDA, Priority Review For Seladelpar; Stock Up 24%

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

CymaBay Therapeutics, Inc. (CBAY) announced on Monday that the U.S. Food and Drug Administration has accepted its New Drug Application or NDA, and granted a priority review for Seladelpar for the treatment of primary biliary cholangitis or PBC.

PBC is a rare, chronic liver inflammatory disease which eventually leads to liver cirrhosis.

The company said that the FDA has set a Prescription Drug User Fee Act or PDUFA target action date of August 14.

Currently, CymaBay's stock is surging 24.52 percent, to $31.99 over the previous close of $25.69 on a volume of 21,183,216 on the Nasdaq.

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