Corcept Therapeutics announces FDA acceptance of relacorilant NDA

Corcept Therapeutics (CORT) announced that the FDA has accepted Corcept’s new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. The FDA has assigned a PDUFA date of July 11, 2026 for the application. Corcept’s NDA is based on positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials. In these trials, patients who received relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel monotherapy, with no need for biomarker selection. Relacorilant was well-tolerated, consistent with its known safety profile. Importantly, relacorilant conferred its benefit without increasing the safety burden of the patients who received it. The type, frequency and severity of adverse events in the combination arms were similar to those in the nab-paclitaxel monotherapy arms.