FDA lifts hold on CymaBay’s NASH drug, but the company may still leave the ailing field
Eight months after a single trial readout blew up their NASH program, their stock price and put development around their lead compound on indefinite hold, CymaBay has been cleared to get back to work.
The FDA has lifted the clinical hold it placed on the company and their experimental seladelpar last year after planned biopsies for their NASH trial revealed “atypical histological findings” — a phrase that here means the drug, rather than reducing patients’ liver fat, appeared to lead to liver damage. The Phase IIb trial was terminated, along with a Phase IIa for primary sclerosing cholangitis (PSC). Studies on primary biliary cholangitis were put on hold. SVB Leerink called it “a worst case scenario” and the stock fell from $5.55 to $1.89.
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