CORCEPT THERAPEUTICS INC 8-K

What Happened
Corcept Therapeutics Incorporated announced on December 31, 2025 (via a press release attached to an 8‑K), that the U.S. Food and Drug Administration issued a Complete Response Letter (CRL) regarding the company’s New Drug Application (NDA) for relacorilant as a treatment for patients with hypertension secondary to hypercortisolism. The company filed this disclosure under Item 8.01 (Other Events) on Form 8‑K.

Key Details

• Date of announcement: December 31, 2025.
• Event: FDA issued a Complete Response Letter for the relacorilant NDA.
• Indication: relacorilant was submitted for treatment of hypertension secondary to hypercortisolism.
• Disclosure: press release attached as Exhibit 99.1 to the Form 8‑K.

Why It Matters
A Complete Response Letter means the FDA will not approve the NDA in its current form and typically describes what issues must be addressed before approval can be granted. For investors, this is a material regulatory setback that affects the timing and uncertainty of potential future approval and commercial prospects for relacorilant. Corcept’s next public updates (additional filings, communications or regulatory responses) will be important for assessing the path forward.