Corcept faces securities class action over relacorilant NDA statements

A securities class action lawsuit has been filed against Corcept Therapeutics Incorporated and certain of its officers on behalf of investors who purchased or otherwise acquired Corcept securities between October 31, 2024 and December 30, 2025. The complaint alleges that defendants made materially false and misleading statements and failed to disclose that the FDA had repeatedly raised concerns regarding the adequacy of the clinical evidence supporting the relacorilant New Drug Application for hypercortisolism.

The action alleges that defendants represented that the key clinical trials supporting relacorilant were "powerful support" for Corcept's New Drug Application to the FDA and stated that they had communicated with the FDA, were confident in submitting the NDA, and foresaw no impediments to approval. Toward the latter part of the class period, defendants repeatedly told investors that "relacorilant is approaching approval," when, according to the complaint, there was a known material risk that Corcept's relacorilant NDA would not be approved.

The complaint states that the truth emerged on December 31, 2025, when Corcept revealed that the FDA had issued a Complete Response Letter regarding the NDA for relacorilant as a treatment for patients with hypercortisolism. The company said the FDA had "concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness." Following this disclosure, the price of Corcept common stock declined by $35.40 per share, or 50.4%.

On January 30, 2026, the FDA published a redacted copy of the Complete Response Letter. The letter detailed concerns that the clinical studies submitted as part of the NDA were not sufficient evidence of relacorilant's efficacy for the proposed indication and noted that, during pre-submission meetings, the FDA had informed Corcept "on several occasions" of its concerns about the adequacy of the clinical development program and had warned the company "to expect significant review issues" if it submitted the application.

The case was filed in the U.S. District Court for the Northern District of California on behalf of all investors who purchased or otherwise acquired Corcept common stock during the class period. Investors who wish to seek appointment as lead plaintiff must file a motion with the court by April 21, 2026.

Corcept is a pharmaceutical company focused on the development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol. Relacorilant is one of its lead new product candidates and is being developed for multiple indications, including as a treatment for patients with hypercortisolism, also known as Cushing's syndrome.