A securities class action has been filed against Corcept Therapeutics Incorporated (CORT) on behalf of all investors who purchased or otherwise acquired Corcept common stock between October 31, 2024 through December 30, 2025. This case has been filed in the USDC – NDCA.
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. One of its lead new product candidates is relacorilant, which is being developed for multiple indications, including as a treatment for patients with hypercortisolism (also known as “Cushing’s syndrome”).
The complaint alleges that, throughout the Class Period, Defendants represented that the key clinical trials supporting the use of relacorilant as treatment for patients with hypercortisolism were “powerful support” for the New Drug Application (“NDA”) that Corcept submitted to the U.S. Food and Drug Administration (“FDA”) for this indication. Defendants also stated that they had communicated with the FDA about this NDA and were confident in submitting the NDA, foreseeing no impediments to approval. Toward the latter part of the Class Period, Defendants repeatedly told investors that “relacorilant is approaching approval.” In truth, the FDA had repeatedly raised concerns about the adequacy of the clinical evidence supporting the relacorilant NDA and, as a result, there was a known material risk that Corcept’s relacorilant NDA would not be approved.
The truth emerged on December 31, 2025, when Corcept revealed that the FDA had issued a Complete Response Letter (“CRL”) regarding the NDA for relacorilant as a treatment for patients with hypercortisolism. The press release issued by the Company stated that the FDA had “concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness.” As a result of this disclosure, the price of Corcept common stock declined by $35.40 per share, or 50.4%.
On January 30, 2026, after the end of the Class Period, the FDA published a redacted copy of the CRL. The CRL detailed the FDA’s concerns with the relacorilant NDA, including concerns that the clinical studies that were submitted as part of the NDA were not sufficient evidence of relacorilant’s efficacy for the proposed indication. The CRL also noted that, during pre-submission meetings, the FDA 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.