Corcept Therapeutics Submits Marketing Authorization Application to EMA for Relacorilant in Platinum-Resistant Ovarian Cancer; FDA Review Ongoing

Reuters
2025/10/14
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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Corcept Therapeutics Incorporated published the original content used to generate this news brief via Business Wire (Ref. ID: 20251014154513) on October 14, 2025, and is solely responsible for the information contained therein.

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