Setback for Corcept: FDA Issues Complete Response Letter for Relacorilant in Hypercortisolism Treatment
Corcept Therapeutics Incorporated (NASDAQ: CORT) disclosed in a Form 8-K filing on December 31, 2025, that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for relacorilant as a treatment for patients with hypercortisolism (Cushing’s syndrome). The company announced this development via a press release attached as Exhibit 99.1 to the 8-K.
Key details from the filing and press release:
- The FDA acknowledged that Corcept’s pivotal Phase 3 GRACE trial met its primary endpoint, showing improvements in hypertension and hyperglycemia.
- Data from the Phase 3 GRADIENT trial provided confirmatory evidence of relacorilant’s effects.
- However, the Agency determined it could not reach a favorable benefit-risk assessment without additional evidence of effectiveness.
Corcept expressed surprise and disappointment, with CEO Joseph K. Belanoff, M.D., stating: “We are surprised and disappointed by this outcome. Our commitment to patients suffering from the effects of hypercortisolism is unwavering. I am confident we will find a way to get relacorilant to the patients it could help. We will meet with the FDA as soon as possible to discuss the best path forward.”
Relacorilant is a selective cortisol modulator in development for multiple indications, including platinum-resistant ovarian cancer (PDUFA date: July 11, 2026). The drug is proprietary to Corcept, with orphan drug designation in both the U.S. and Europe for hypercortisolism.
This CRL represents a significant regulatory hurdle for Corcept’s lead pipeline candidate in hypercortisolism, potentially requiring additional clinical data or trials. The company plans to engage promptly with the FDA to clarify next steps.
For U.S. investors and patients, this development impacts Corcept’s growth trajectory beyond its commercial product Korlym (mifepristone), used for the same indication. Shares reacted sharply in premarket trading on January 1, 2026, reflecting market concerns over delayed approval and associated revenue potential.
The full Form 8-K, including the press release under Items 2.02 and 8.01 (Results of Operations and Financial Condition; Other Events), is available on the SEC’s EDGAR database and Corcept’s investor relations site.
By Sam Michael
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