Corcept Therapeutics Incorporated (NASDAQ: CORT) has announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026, for the application.
The NDA for relacorilant is supported by positive data from pivotal Phase 3 ROSIOLA and Phase 2 trials. Patients who received relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival compared to those who received nab-paclitaxel monotherapy. The combination was well-tolerated, and the adverse events in the combination arms were similar to those in the monotherapy arms.
Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. It has been designated as an orphan drug by the FDA and the European Commission for the treatment of hypercortisolism and ovarian cancer.
The FDA has also assigned a PDUFA date of December 30, 2025, for relacorilant as a treatment for patients with hypercortisolism.
Ovarian cancer is the fifth most common cause of cancer death in women, and patients with platinum-resistant disease have limited treatment options. Corcept's CEO, Joseph Belanoff, M.D., expressed optimism about the potential of relacorilant to redefine how platinum-resistant ovarian cancer is treated.
Corcept Therapeutics has been focusing on cortisol modulation for over 25 years, leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. The company is also conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS, and liver disease. Following these announcements, the company's shares moved 0.12%, and are now trading at a price of $71.815. Check out the company's full 8-K submission here.
