Corcept Therapeutics Submits Marketing Authorization Application to EMA for Relacorilant in Platinum-Resistant Ovarian Cancer; FDA Review Ongoing
Reuters
Oct 14, 2025
Corcept <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Submits Marketing Authorization Application to EMA for Relacorilant in Platinum-Resistant Ovarian Cancer; FDA Review Ongoing
Corcept Therapeutics Incorporated has submitted a Marketing Authorization Application $(MAA)$ to the European Medicines Agency $(EMA)$ for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. The submission is based on positive data from Phase 2 and pivotal Phase 3 ROSELLA trials, which showed improved progression-free and overall survival with relacorilant plus nab-paclitaxel compared to nab-paclitaxel alone, with a similar safety profile. Additionally, the U.S. Food and Drug Administration (FDA) is currently reviewing Corcept's application to market relacorilant for the same indication, with a Prescription Drug User Fee Act (PDUFA) target action date set for July 11, 2026. No grant or funding from multiple organizations was mentioned.
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