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The FDA announced Friday that a group of independent experts would meet in May to discuss the marketing application for obeticholic acid (OCA), a liver disease candidate developed by Intercept Pharmaceuticals (NASDAQ:ICPT) for nonalcoholic steatohepatitis (NASH).
Intercept (ICPT) fell ~2% lower in pre-market after the news, while rival drug developer NASH Madrigal Pharmaceuticals (MDGL) has added ~5%.
According to the FDA, its Gastrointestinal Drugs Advisory Committee will meet on May 19 from 9 a.m. to to discuss treatment, a farnesoid X receptor (FXR) agonist already on the market as Ocaliva for primary biliary cholangitis of rare autoimmune diseases.
In January, the FDA accepted the company’s New Drug Application (“NDA”) for OCA for liver fibrosis due to NASH, granting June 22, 2023 as the target action date. With its Q4 2022 results, Intercept (ICPT) indicated that there would be an AdCom meeting before the decision.
FDA advisory committees issue non-binding recommendations. However, the regulator usually follows them before making a final decision on authorizations.
Read: Seeking Alpha contributor BioSci Capital Partners issued a Buy rating on Intercept (ICPT) in January, expecting the stock to deliver “various returns.”
