CymaBay's seladelpar scores in Phase III cholangitis trial

8 September 2023
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US biopharma CymaBay Therapeutics (Nasdaq: CBAY) traded up as much as 21% to $16.73 yesterday, as the company released encouraging trial results for its primary biliary cholangitis (PBC) candidate after earlier disappointments.

CymaBay announced positive top-line results from its Phase III pivotal RESPONSE study, evaluated the safety and efficacy of seladelpar, a potent, selective, orally active delpar or PPARδ agonist, in development for the treatment of adult patients with PBC.

The registration trial achieved the primary and all key secondary endpoints, and CymaBay noted that this supports advancement to regulatory discussions and filing for regulatory approval with the US Food and Drug Administration (FDA), the Medicines and Healthcare products Regulatory Agency (MHRA), and the European Medicines Agency (EMA).

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