Corcept Therapeutics Incorporated (NASDAQ: CORT) has recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its proprietary drug, relacorilant, as a treatment for patients with platinum-resistant ovarian cancer. This submission is supported by positive data from pivotal phase 3 trials, where patients who received relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival compared to those who received nab-paclitaxel monotherapy. Notably, relacorilant was well-tolerated, and the adverse events in the combination arms were similar to those in the monotherapy arms.
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. This indicates the potential approval timeline for this indication.
Ovarian cancer is the fifth most common cause of cancer death in women, and patients with platinum-resistant disease have limited treatment options. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with a similar number in Europe. This underscores the significant unmet medical need that relacorilant aims to address.
Corcept's CEO, Joseph K. Belanoff, M.D., highlighted the importance of this submission, noting that it represents a significant milestone for the company, with two NDAs now before the FDA. He emphasized the need for better treatment options for patients living with these diseases and expressed the company's commitment to making relacorilant available immediately following regulatory approval.
Relacorilant, an oral therapy, is a selective glucocorticoid receptor antagonist that modulates cortisol activity by binding to the glucocorticoid receptor without affecting the body's other hormone receptors. It has been designated an orphan drug by the FDA and the European Commission for the treatment of hypercortisolism and ovarian cancer, and it is also being developed for other serious disorders, including endogenous hypercortisolism and prostate cancer.
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 conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS, and liver disease. In February 2012, Corcept introduced Korlym®, the first medication approved by the FDA for the treatment of patients with endogenous hypercortisolism. As a result of these announcements, the company's shares have moved 0.45% on the market, and are now trading at a price of $72.20. If you want to know more, read the company's complete 8-K report here.
