Corcept Therapeutics (CORT) on Wednesday said the U.S. Food and Drug Administration has issued a Complete Response Letter for the New Drug Application of relacorilant to treat hypertension secondary to hypercortisolism.
While the FDA acknowledged that Corcept's pivotal GRACE trial met its primary endpoint and that data from the GRADIENT study provided supportive evidence, the agency said additional proof of effectiveness is needed to support a favorable benefit-risk assessment.
CORT is currently trading at $33.81, down $36.38 or 51.83 percent on the Nasdaq.
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