FDA Accepts Submission of New Drug Application for CORLUX for Cushing's Syndrome

Corcept Therapeutics Incorporated CORT today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application, which was submitted on April 15, 2011, for CORLUX, a glucocorticoid receptor type II (GR-II) antagonist, for the treatment of the manifestations of Cushing's Syndrome. The FDA has indicated that this application will receive a standard review and that the Prescription Drug User Fee Act (PDUFA) goal date for completion of its review is February 17, 2012. We are executing our commercial plans related to CORLUX for the treatment of Cushing's Syndrome based on the projected timeline for the FDA review of our NDA. This includes conducting market research and engaging third-party vendors to support distribution and other logistical needs for product launch, if CORLUX is approved by the FDA.