Shaking off trial hold, seladelpar program is back on track
Shares in CymaBay Therapeutics (Nasdaq: CBAY) have been lifted by a quarter after the liver disease specialist announced multiple clinical holds for seladelpar had been lifted.
The US Food and Drug Administration (FDA) agreed work could continue for all three Investigational New Drug (IND) applications, in non-alcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC).
In November 2019, based on initial histological findings from a Phase IIb study in NASH, the firm opted to halt clinical development of the oral PPARδ agonist. At the time, shares in the company fell more than three-quarters.
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