The FDA Has Issued A Complete Response Letter Regarding Corcept Therapeutics' New Drug Application For Relacorilant For Hypertension Secondary To Hypercortisolism

While the FDA acknowledged that Corcept's pivotal GRACE trial met its primary endpoint and that data from the company's GRADIENT trial provided confirmatory evidence, the Agency concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness.