regulatory
confidence high
sentiment positive
materiality 0.85
FDA accepts Corcept's NDA for relacorilant in Cushing's syndrome; PDUFA Dec 30, 2025
CORCEPT THERAPEUTICS INC
- FDA filed relacorilant NDA for endogenous hypercortisolism (Cushing's syndrome).
- PDUFA target action date set for December 30, 2025.
- NDA supported by positive GRACE, GRADIENT, and Phase 2 trial results.
- No drug-induced adrenal insufficiency, hypokalemia, or QT prolongation observed in trials.
- CEO states relacorilant has potential to become new standard of care.