FDA Accepts New Drug Application for Corcept Therapeutics's (CORT) Relacorilant

Corcept Therapeutics Incorporated (NASDAQ:CORT) is one of the Best Performing Long Term Stocks According to Analysts. On September 10, Corcept Therapeutics Incorporated (NASDAQ:CORT) announced that the FDA has accepted its new drug application for Relacorilant to treat platinum-resistant ovarian cancer.

Management noted that the FDA has set a decision date of July 11, 2026, under the Prescription Drug User Fee Act. The application acceptance is based on the positive results from the Phase 3 ROSELLA trial and earlier Phase 2 studies.

In these trials, Relacorilant was combined with the chemotherapy drug nab-paclitaxel. The results showed that patients receiving this combination showed better progression-free survival and overall survival than those on nab-paclitaxel alone. Notably, Relacorilant did not add safety risks, while the rates and severity of side effects were similar between the combination and monotherapy groups.

Corcept Therapeutics Incorporated (NASDAQ:CORT) is a pharmaceutical company that discovers, develops, and commercializes medications targeting severe diseases by modulating cortisol, a hormone linked to various disorders.

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Disclosure: None. This article is originally published at Insider Monkey.