FDA issues Complete Response Letter for Corcept's relacorilant NDA in hypercortisolism

CORCEPT THERAPEUTICS INC

FDA concluded benefit-risk assessment unfavorable without additional effectiveness evidence.
Pivotal GRACE trial met primary endpoint; GRADIENT trial provided confirmatory evidence.
CEO Joseph Belanoff expressed surprise and disappointment; plans to meet with FDA.
Relacorilant was under review for hypertension secondary to hypercortisolism.

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