Corcept Therapeutics Resubmits NDA for Relacorilant
Corcept Therapeutics announced it will resubmit its New Drug Application, NDA, to the U.S. Food and Drug Administration, FDA, for relacorilant as a treatment for patients with Cushing's syndrome. "Following issuance of its complete response letter, the FDA asked us to conduct additional analyses of our NDA data," said Joseph Belanoff, M.D., Corcept's Chief Executive Officer. "Based on the positive outcome of those analyses and the productive tenor of our discussions, we plan to resubmit our NDA in the coming weeks. The agency has told us to expect a Prescription Drug User Fee Act date six months after the date of our submission. We appreciate the FDA's continued engagement with our efforts to bring relacorilant's benefits to patients with hypercortisolism."
