FDA to Review Intercept Pharmaceuticals' Obeticholic Acid for Pre-Cirrhotic Fibrosis in NASH.

Trading of Intercept Pharmaceuticals' common stock has been halted as the FDA's Gastrointestinal Drugs Advisory Committee reviews obeticholic acid as a treatment for pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 22, 2023, for the review of the New Drug Application (NDA) for obeticholic acid. Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases.