cept Therapeutics rporated(US:CORT) 美股IPO·2026-01-01 04:13Core Viewpoint - Corcept Therapeutics has received a complete response letter from the FDA indicating that its new drug application for Relacorilant has not been approved for treating secondary hypertension caused by hypercortisolism [2][4]. Group 1: FDA Response and Clinical Trials - The FDA confirmed that Corcept's pivotal GRACE clinical trial met its primary endpoint, and the data from the GRADIENT trial is considered confirmatory [4]. - However, the FDA requires additional evidence of efficacy to support a favorable benefit-risk assessment for the therapy [4]. - Corcept has conducted multiple clinical trials related to Cushing's syndrome [12]. Group 2: Patient Outcomes - Improvements in blood sugar control have been observed in patients [6]. - Significant enhancements in patients' quality of life and cognitive assessments have been reported [9]. Group 3: Future Development Plans - Corcept's CEO expressed surprise and disappointment at the FDA's decision and stated that the company will meet with the FDA to discuss the best path forward [16]. - Relacorilant is a selective glucocorticoid receptor antagonist being developed not only for endogenous hypercortisolism but also for ovarian cancer and other diseases [16]. - The PDUFA date for the application concerning platinum-resistant ovarian cancer is set for July 11, 2026, with market approval expected by the end of 2026 [17][18].