FDA Accepts New Drug Application for Corcept Therapeutics’s (CORT) Relacorilant

Core Insights - Corcept Therapeutics Incorporated (NASDAQ:CORT) has received FDA acceptance for its new drug application for Relacorilant, aimed at treating platinum-resistant ovarian cancer [1][2] - The FDA has set a decision date of July 11, 2026, under the Prescription Drug User Fee Act [2] - Positive results from the Phase 3 ROSELLA trial and earlier Phase 2 studies supported the application acceptance [2] Clinical Trial Results - In the trials, Relacorilant was combined with nab-paclitaxel, showing improved progression-free survival and overall survival compared to nab-paclitaxel alone [3] - The combination therapy did not introduce additional safety risks, with side effect rates and severity being similar between the combination and monotherapy groups [3] Company Overview - Corcept Therapeutics is a pharmaceutical company focused on discovering, developing, and commercializing medications that target severe diseases by modulating cortisol, a hormone associated with various disorders [4]