新药申请未获FDA批准 Corcep医疗(CORT.US)暴跌超46%

Core Viewpoint - Corcept Medical's stock price plummeted over 46% to $37.33 following the announcement that its new drug application for Relacorilant was not approved by the FDA [1] Group 1: FDA Response - The FDA issued a complete response letter indicating that while Corcept's key GRACE clinical trial met its primary endpoint and the GRADIENT trial data is considered confirmatory, the existing data is insufficient for a favorable benefit-risk assessment [1] - The FDA has requested additional evidence of efficacy to support the drug's approval [1] Group 2: Company Reaction - Corcept's CEO Joseph K. Belanoff expressed surprise and disappointment at the FDA's decision and stated that the company will meet with the FDA as soon as possible to discuss the best path forward [1] Group 3: Drug Information - Relacorilant is an oral selective glucocorticoid receptor antagonist, being developed not only for endogenous Cushing's syndrome but also for ovarian cancer and other conditions [1] - The setback in approval introduces further uncertainty into the commercialization process of the drug, with market attention now focused on subsequent regulatory communications and the advancement of supplementary research plans [1]