FDA Accepts Corcept's New Drug Application for Relacorilant as Treatment for Platinum-Resistant Ovarian Cancer, PDUFA Date Set for July 2026
Corcept Therapeutics Incorporated has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026, for the application. This NDA submission is based on positive results from Corcept's Phase 3 ROSELLA and Phase 2 trials, which showed that patients receiving relacorilant in combination with nab-paclitaxel experienced improved progression-free and overall survival compared to those receiving nab-paclitaxel alone. The treatment was well-tolerated, without increasing patients' safety burden. This regulatory review brings Corcept closer to providing a new treatment option for this challenging form of ovarian cancer.
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: 20250910770269) on September 10, 2025, and is solely responsible for the information contained therein.
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