Corcept Therapeutics Incorporated has recently submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its proprietary, selective cortisol modulator, relacorilant, as a treatment for patients with platinum-resistant ovarian cancer. This submission is based on positive data from its pivotal phase 3 Rosella and phase 2 trials. In these trials, patients who received relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel monotherapy. Relacorilant was well-tolerated, and the type, frequency, and severity of adverse events in the combination arms were similar to those in the nab-paclitaxel monotherapy arms.
Corcept's CEO, Joseph K. Belanoff, M.D., stated that this submission marks an important milestone for the company as they now have two NDAs before the FDA: relacorilant in combination with nab-paclitaxel as a treatment for platinum-resistant ovarian cancer and relacorilant as a treatment for patients with hypercortisolism. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025, for relacorilant as a treatment for patients with hypercortisolism.
Ovarian cancer is described as the fifth most common cause of cancer death in women, and Corcept's focus on cortisol modulation has led to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Additionally, the company is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, amyotrophic lateral sclerosis (ALS), and liver disease.
The market has reacted to these announcements by moving the company's shares 0.45% to a price of $72.20. If you want to know more, read the company's complete 8-K report here.
