Corcept Therapeutics Incorporated (NASDAQ: CORT) announced it will resubmit its New Drug Application to the U.S. Food and Drug Administration for relacorilant as a treatment for patients with Cushing's syndrome.

The FDA previously issued a complete response letter and requested additional analyses of the NDA data, according to a company statement. Chief Executive Officer Joseph K. Belanoff said the company plans to resubmit the application in the coming weeks based on positive outcomes from those analyses.

The FDA indicated it expects to assign a Prescription Drug User Fee Act date six months after the submission date. The PDUFA date represents the target deadline for the agency to complete its review of the application.

Relacorilant is being developed as a treatment for hypercortisolism, also known as Cushing's syndrome, which is caused by excessive cortisol activity. The condition can affect multiple organ systems and may be fatal if left untreated effectively.

Corcept currently markets Korlym, which received FDA approval in 2012 as the first medication for treating patients with endogenous Cushing's syndrome. The company also received approval for Lifyorli in 2026, a selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer when used in combination with nab-paclitaxel.

The Redwood City, California-based company focuses on cortisol modulation and has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease.