Corcept Therapeutics (CORT) said Wednesday it will resubmit its new drug application to the US Food and Drug Administration in the coming weeks for relacorilant to treat Cushing's syndrome, also known as hypercortisolism.
The company said it will resubmit the NDA based on positive outcomes of additional analyses of the application data, which were conducted following issuance of a complete response letter.
The FDA notified the company to expect a Prescription Drug User Fee Act date six months following the application submission, according to a statement.
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