Corcept Faces Investor Suit Over Relacorilant NDA Disclosure 

Corcept Therapeutics (CORT) told investors approval was on track through December 2025. Then the company disclosed that the FDA had issued a Complete Response Letter for relacorilant, sending the stock down 50.4% in one day. A lawsuit alleges the FDA had already warned Corcept to expect major review issues.  

Corcept Therapeutics has been sued over allegations that it overstated the strength of its relacorilant data and its communications with the FDA before the agency rejected the application. Investors are watching because the complaint alleges that the company’s stock fell sharply after Corcept disclosed the FDA’s decision and the reasons for it. 

The complaint says the class period runs from October 31, 2024, through December 30, 2025, and alleges that Corcept common stock dropped $35.40 per share, or 50.4%, after the December 31, 2025, disclosure. That decline, according to the complaint, followed Corcept’s announcement that the FDA had issued a Complete Response Letter for the relacorilant New Drug Application (“NDA”). 

Affected investors may wish to learn more about whether they qualify. 

Company Background 

Corcept is described in the complaint as a commercial-stage pharmaceutical company focused on medications that treat severe endocrinologic, oncologic, metabolic, and neurologic disorders by modulating cortisol. The complaint says the company has marketed Korlym since 2012 for patients with hypercortisolism and has developed relacorilant, a newer cortisol modulator intended to treat hypercortisolism without the side effects associated with Korlym. 

The lawsuit places relacorilant at the center of the case because Corcept had completed two Phase 3 studies, GRACE and GRADIENT, and was preparing an NDA for FDA review. The complaint says that, during the Class Period, management repeatedly told investors that relacorilant was on track for approval. 

Core Allegations 

The complaint focuses on Corcept’s relacorilant NDA and the company’s public statements about the likelihood of approval. It alleges that Corcept portrayed the clinical data as strong support for the filing while omitting that the FDA had already raised concerns about the adequacy of the evidence. 

According to the complaint, the alleged misconduct was that Corcept told investors the FDA review was progressing well, when in truth the agency had warned the company about issues with the clinical development program and expected significant review issues if the NDA was submitted. The lawsuit presents the case as a mismatch between management’s upbeat public remarks and the agency concerns later revealed in the CRL. 

Readers following the matter may want to monitor the case as it develops. 

Management Statements 

The complaint quotes several statements by executives made before the FDA’s decision. On October 30, 2024, Joseph Belanoff said the GRACE and GRADIENT results “clear the path” for the NDA and that the GRACE outcomes would provide “powerful evidence” for the filing, while William Guyer said the company was “very confident” about submitting an NDA based on GRADIENT data. 

The complaint also says Gary Charles Robb told investors that the FDA had made clear a single well-controlled study with confirmatory evidence was sufficient, and that the company was in “a good position” with the NDA. Belanoff separately said Corcept had talked to the FDA “plenty” about the program and that he foresaw “absolutely no impediments” to getting the NDA in. 

Later remarks were similarly optimistic. On December 30, 2024, Corcept said the NDA was based on positive GRACE results and confirmatory evidence from GRADIENT and extension studies, and Belanoff said relacorilant had the potential to become the standard of care. On February 26, May 5, July 31, and November 4, 2025, Belanoff and Sean Maduck repeatedly described the NDA as moving toward approval and spoke of multibillion-dollar annual revenue potential. 

Corrective Disclosures 

The complaint identifies December 31, 2025, as the key corrective disclosure date. On that day, Corcept said the FDA had issued a Complete Response Letter for relacorilant and had concluded it could not reach a favorable benefit-risk assessment without additional evidence of effectiveness. The complaint says the stock fell $35.40 per share, or 50.4%, from $70.20 on December 30, 2025, to $34.80 on December 31, 2025. 

The complaint also discusses a later disclosure on January 30, 2026, when the FDA published a redacted copy of the CRL. That document allegedly confirmed that the agency could not approve the application in its present form, said that the evidence from GRACE and GRADIENT was insufficient, and stated that the FDA had warned Corcept during pre-submission meetings about concerns regarding the adequacy of the clinical development program and the likelihood of significant review issues. 

Why This Matters to Investors 

At the center of the complaint is the claim that investors bought Corcept shares at inflated prices, based on statements suggesting FDA approval was likely and that no major review obstacles existed. The complaint alleges that those statements were undermined when the FDA rejected the application and stated that more evidence was needed. 

For shareholders who traded during the Class Period, the complaint argues that the December 31, 2025, stock decline reflected the market’s reaction to information that should have been disclosed earlier. The case may therefore matter most to investors who say they relied on Corcept’s public optimism about relacorilant while the FDA’s concerns remained undisclosed. 

Legal Claims 

The complaint alleges violations of Section 10(b) of the Exchange Act, Rule 10b-5, and Section 20(a) against the officer defendants. It claims the challenged statements were false or misleading because they overstated the strength of the NDA and failed to disclose the FDA’s concerns about the adequacy of the supporting clinical evidence. 

The plaintiff says the alleged omissions and misstatements caused investors to buy Corcept stock at inflated prices and suffer losses when the FDA’s decision became public. It also alleges that the officer defendants controlled the company and are responsible for the challenged disclosures. 

Investors may wish to learn more about their rights in connection with this matter. 

About Levi & Korsinsky, LLP 

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