Consensus Needs to Come Down on Intercept (ICPT) after FDA Review is Extended - Leerink
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FDA Extends PDUFA Date for Obeticholic Acid for the Treatment of PBC
December 17, 2015 5:00 PM ESTNEW YORK, Dec. 17, 2015 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic, underserved liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its Priority Review of obeticholic acid (OCA) in primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC). In response to an information request from the FDA, additional clinical data analyses have been submitted. To provide time for a full review... More
