CymaBay Therapeutics (NASDAQ:CBAY) jumps 22% premarket on the heels of its announcement that the FDA has removed clinical holds on seladelpar for all three IND Applications in Nonalcoholic Steatohepatitis (NASH), Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC).
On November 25, 2019, CymaBay halted all clinical trials based on initial histological findings observed in the Phase 2b study of seladelpar in NASH.
An in-depth investigation was conducted and the expert panel found no clinical, biochemical or histological evidence of seladelpar-related liver injury in the Phase 2 NASH study. The panel unanimously supported re-initiating development of seladelpar pending FDA approval.
Based on these results, the Agency concluded that clinical trials for NASH, PBC and PSC may resume.
Seladelpar is a potent, selective, orally active PPARδ agonist that is in development for the treatment of the liver diseases with the lead indication being PBC.
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