The U.S. FDA issued a complete response letter to Corcept Therapeutics for relacorilant in the indication of hypertension secondary to hypercortisolism (Cushing syndrome), requesting additional efficacy evidence. The CRL halts Corcept’s near‑term plans for that indication and sent shares sharply lower. The company intends to engage the agency and to focus continuing efforts on a July 2026 PDUFA for relacorilant in platinum‑resistant ovarian cancer. The CRL underscores regulatory scrutiny on efficacy endpoints in endocrine indications and forces Corcept to recalibrate development and regulatory strategies while maintaining its oncology filing timeline.