CORT Corcept Therapeutics Inc DEC 31 UPDATE CRL

n March 3, 2025, the FDA filed Corcept’s NDA for relacorilant as a treatment for adult patients with endogenous hypercortisolism (Cushing’s syndrome), assigning a PDUFA target action date of December 30, 2025. The NDA is based on the pivotal Phase 3 GRACE study, confirmatory evidence from Phase 3 GRADIENT, long-term extension data and a Phase 2 study in hypercortisolism.