Corcept Therapeutics will resubmit its NDA for Cushing’s syndrome drug Relacorilant in coming weeks and expects an FDA decision six months after submission under the Prescription Drug User Fee Act. Shares jumped over 7%, marking a five-session rally to reach their highest 2026 level.
Corcept plans to file its New Drug Application for Relacorilant in the coming weeks after positive discussions with the FDA. The company has been informed to expect a Prescription Drug User Fee Act decision six months after the resubmission date.
Following the resubmission announcement, shares of Corcept rose more than 7% in early trading, extending a five-session winning streak and reaching the highest price levels seen in 2026.
In December 2025, the FDA declined to accept the original NDA, citing the need for additional proof of Relacorilant’s effectiveness in treating Cushing’s syndrome before granting approval.
Relacorilant is designed to address hypercortisolism in Cushing’s syndrome patients, a condition linked to high blood pressure, obesity, elevated blood sugar and serious cardiovascular risks when left untreated.
