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

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typeContent_19130:::2024-02-12T14:49:00

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

CymaBay Therapeutics, Inc. (CBAY) made a public statement on Monday revealing that its New Drug Application for Seladelpar, designed to treat primary biliary cholangitis, has been acknowledged and assigned priority review status by the U.S. Food and Drug Administration (FDA).

Primary biliary cholangitis is a rare chronic liver inflammatory disease that can eventually culminate in liver cirrhosis.

The FDA has set a date of August 14 as per the Prescription Drug User Fee Act target action date, in relation to CymaBay's application.

After this announcement, CymaBay's stock experienced an impressive surge of 24.52 percent to $31.99, up from the previous close of $25.69, with trading volumes reaching 21,183,216 on the Nasdaq.

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