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 assigned a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026, for the application.
This NDA is based on positive data from Corcept's pivotal Phase 3 Rosella 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, with no need for biomarker selection.
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 an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer.
For patients with hypercortisolism, the FDA has assigned a PDUFA date of December 30, 2025, for relacorilant. Additionally, Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS, and liver disease.
Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.
Corcept Therapeutics has been focused 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 headquartered in Redwood City, California. Today the company's shares have moved 0.7% to a price of $71.73. For the full picture, make sure to review CORCEPT THERAPEUTICS INC's 8-K report.
