Corcept Submits NDA For Relacorilant To Treat Platinum-Resistant Ovarian Cancer

(RTTNews) - Corcept Therapeutics Incorporated (CORT), a commercial-stage biopharma company focused on cortisol modulation, has submitted a New Drug Application - NDA to the U.S. FDA for relacorilant in combination with nab-paclitaxel for treating platinum-resistant ovarian cancer.

The NDA is supported by data from Corcept's Phase 3 ROSELLA and earlier Phase 2 trials, which showed that patients receiving relacorilant with nab-paclitaxel experienced improved progression-free and overall survival compared to those on nab-paclitaxel alone. The treatment was well-tolerated and did not increase the incidence or severity of adverse events relative to standard therapy, indicating a favorable safety profile.

CEO Joseph K. Belanoff stated that this marks a significant milestone for the company, as it now has two NDAs under FDA review, one for relacorilant in oncology and another for hypercortisolism. He added that the company's oncology and endocrinology teams are preparing to ensure swift availability of relacorilant upon regulatory approval.

CORT currently trades at $72.03 or 0.21% higher on the NasdaqCM.