CymaBay floored by seladelpar's NASH failure
Shares in CymaBay Therapeutics (Nasdaq: CBAY) closed 76% down on Monday after the company announced it was terminating its Phase IIb study of seladelpar in non-alcoholic steatohepatitis (NASH) and its recently initiated Phase II study of seladelpar in primary sclerosing cholangitis (PSC).
The Californian firm, which is is also putting on hold all studies of its lead drug in primary biliary cholangitis (PBC), says that it is taking this action based on initial histological findings observed in the Phase IIb study of seladelpar in NASH.
"These findings were unexpected based on our pre-clinical and clinical experience with seladelpar to date"Planned, blinded histological assessments of the first tranche of liver biopsies in the trial revealed atypical histological findings, including histology characterized as an interface hepatitis presentation, with or without biliary injury. CymaBay is investigating to better understand these findings.
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