Corcept Therapeutics Resubmits New Drug Application
The company states: "Corcept Therapeutics announced it has resubmitted its New Drug Application to the U.S. Food and Drug Administration for relacorilant as a treatment for patients with Cushing's syndrome. As requested by the FDA, the resubmission includes additional analyses of data included in the original NDA submission. Corcept expects the resubmission to receive a six-month review. Corcept's resubmission is based on positive data from its pivotal GRACE trial, the double-blind, placebo-controlled Phase III GRADIENT trial, relacorilant's long-term extension study and earlier-stage development data. Corcept believes that these data show that relacorilant provides meaningful, durable improvements in the signs and symptoms of Cushing's syndrome, without causing some of the serious adverse events associated with currently approved medications - termination of pregnancy, hypokalemia, endometrial hypertrophy, vaginal bleeding, adrenal insufficiency and QT prolongation."
