Corcept to Resubmit Cushing's Syndrome Drug Application to FDA

Corcept Therapeutics to Resubmit Cushing's Syndrome Drug Application to FDA

Corcept Therapeutics announced plans to resubmit its New Drug Application (NDA) to the U.S. Food and Drug Administration for relacorilant, a treatment for hypercortisolism, also known as Cushing's Syndrome. The resubmission follows the FDA's December request for additional evidence of effectiveness.

Resubmission Process

Corcept CEO Joseph Belanoff stated that after receiving the FDA's complete response letter, the agency requested additional analyses of the NDA data. Following positive results and productive discussions, the company plans to resubmit the application in the coming weeks. Belanoff expressed appreciation for the FDA's continued engagement throughout the process.

Market Reaction

Shares of Corcept rose 6% to $64 in premarket trading. Investors are optimistic that the resubmission could lead to approval if the additional data satisfies the FDA's requirements.