ZACKS·2026-01-02 16:26Core Insights - Corcept Therapeutics (CORT) received a complete response letter (CRL) from the FDA regarding its new drug application (NDA) for relacorilant, a selective cortisol modulator intended for treating hypercortisolism (Cushing's syndrome) [1][5] - Following the announcement, Corcept's shares fell by 50.4% on December 31, 2025 [1][5] - The FDA's decision was based on the need for additional evidence of relacorilant's effectiveness, despite positive results from the GRACE and GRADIENT studies [3][5] Regulatory Developments - The NDA for relacorilant was submitted in December 2024, with an expected decision date of December 30, 2025 [2] - The FDA indicated that further studies are required to establish the drug's effectiveness for patients with hypertension secondary to hypercortisolism, which may delay approval [4] Financial Impact - Over the past six months, Corcept's shares have decreased by 51.8%, contrasting with a 3.4% increase in the industry [4] - Korlym, Corcept's currently marketed drug for Cushing's syndrome, generated sales of $559.3 million in the first nine months of 2025, reflecting a year-over-year increase of approximately 13.4% [9] Future Prospects - Corcept is also pursuing relacorilant for other indications, including a combination therapy for platinum-resistant ovarian cancer, with regulatory decisions expected in 2026 [6][7] - The outcome of the FDA's CRL for relacorilant in Cushing's syndrome may influence the upcoming decision regarding its use in ovarian cancer [9]