Corcept Therapeutics (CORT) told investors relacorilant was a promising next-generation treatment for hypercortisolism supported by clinical data and advancing toward FDA review. But when the FDA issued a Complete Response Letter stating it could not approve the application without additional evidence of effectiveness, the stock fell more than 50% in a single day.
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Investors in Corcept Therapeutics are weighing their options after the company’s stock lost more than half its value in a single day, following what a new lawsuit alleges were repeated misrepresentations about the prospects of a key drug approval.
A securities lawsuit filed in the Northern District of California alleges that Corcept and several of its senior executives told investors throughout a 14-month period that the company’s lead drug candidate, relacorilant, was supported by clinical data and progressing toward potential FDA approval, while the FDA had privately warned the company on multiple occasions that its clinical program had significant deficiencies. The class period runs from October 31, 2024, through December 30, 2025. On December 31, 2025, Corcept’s stock fell $35.40 per share, or 50.4%, after the company disclosed that the FDA had rejected the drug application. If you purchased Corcept common stock between October 31, 2024, and December 30, 2025, you may wish to learn more about your potential legal rights.
Corcept Therapeutics: A Drug Company Built Around Cortisol Modulation
Corcept Therapeutics is a commercial-stage pharmaceutical company headquartered in Redwood City, California. The company focuses on developing medications that treat severe endocrinologic, oncologic, metabolic, and neurologic disorders by modulating the effects of the hormone cortisol.
Since 2012, Corcept has marketed Korlym, an FDA-approved medication used to treat certain patients with hypercortisolism associated with Cushing’s syndrome. Korlym’s active ingredient, mifepristone, is effective in treating the condition but carries significant side effects, including the termination of pregnancies and adverse effects such as endometrial thickening and vaginal bleeding. Corcept developed relacorilant specifically to treat hypercortisolism without causing those side effects, completing two Phase 3 clinical trials, GRACE and GRADIENT, before submitting a New Drug Application to the FDA.
Allegations of a Misleading Picture on FDA Approval Prospects
At the heart of this lawsuit is the allegation that Corcept and its executives portrayed the relacorilant drug application as strongly supported and nearing approval, while concealing that the FDA had repeatedly raised concerns about the adequacy of the underlying clinical evidence. The complaint alleges that defendants made materially false and misleading statements across multiple earnings calls and press releases throughout the class period, projecting confidence in FDA approval despite the FDA’s alleged concerns about the adequacy of the clinical evidence.
According to the complaint, the FDA had informed Corcept during pre-submission meetings that it had concerns about the design of the GRACE study and the adequacy of the overall clinical development program, and had expressly warned the company to expect significant review issues if it submitted the application. Despite those alleged warnings, defendants publicly described their clinical trial results as powerful support for the application and expressed no concerns about the FDA review process.
Investors who traded in Corcept shares during the class period may want to follow this case as it develops.
What Executives Said to Investors During the Class Period
During an October 30, 2024 earnings call, CEO Joseph Belanoff told investors that the GRACE and GRADIENT Phase 3 studies cleared the path for the relacorilant NDA submission, stating the GRACE results would on their own provide powerful evidence for the NDA, with GRADIENT providing additional confirmatory support. Chief Development Officer William Guyer stated on the same call that he was very confident in submitting the NDA based on the available data, and assured investors that the totality of evidence represented a successful path to a positive NDA outcome.
Also on that call, Chief Business Officer Gary Robb commented on the company’s pre-submission discussions with the FDA, claiming that the FDA had made clear that a single well-controlled study, alongside confirmatory evidence, was sufficient to demonstrate drug safety and efficacy. Belanoff added that the company had talked to the FDA extensively about the program and that he foresaw absolutely no impediments to getting the NDA submitted.
In subsequent quarters, the tone remained uniformly optimistic. During the May 5, 2025 earnings call, Belanoff stated the NDA was progressing towards approval by the end of the year, while Endocrinology division President Sean Maduck told investors that relacorilant would generate $3 billion to $5 billion in annual revenue from hypercortisolism alone within three to five years. On July 31, 2025, Belanoff told investors that relacorilant is approaching approval, and on November 4, 2025, he assured them that FDA approval of relacorilant for the treatment of hypercortisolism was expected the following month.
How the FDA Rejection Came to Light
On December 31, 2025, Corcept disclosed that the FDA had issued a Complete Response Letter, or CRL, for the relacorilant NDA. The company stated that the FDA concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness. Belanoff was quoted in the press release stating that the company was surprised and disappointed by the outcome. That disclosure caused Corcept’s stock to fall from a closing price of $70.20 on December 30, 2025, to $34.80 on December 31, 2025, a decline of $35.40 per share or 50.4%.
On January 30, 2026, following the end of the class period, the FDA published a redacted copy of the CRL. That document revealed that the FDA had determined it could not approve the application in its present form, and explained that the evidence from the GRACE and GRADIENT studies was not sufficient to demonstrate the effectiveness of relacorilant for the proposed indication. The CRL also disclosed that, during pre-submission meetings, the FDA had informed Corcept on several occasions of its concerns about the adequacy of the clinical development program, including the design of the GRACE study, and had warned the company to expect significant review issues if it submitted the application.
Why CORT Shareholders Are Paying Attention
The complaint alleges that throughout a 14-month period, Corcept management repeatedly told investors that the FDA review was proceeding smoothly and that approval was imminent, while the FDA had privately flagged significant deficiencies in the clinical program. According to the complaint, investors allege that once the FDA’s concerns and the Complete Response Letter became public, Corcept’s stock price declined sharply. When the FDA rejection was disclosed, the stock lost more than half its value in a single trading session, wiping out substantial amounts of investor capital.
The complaint also notes that while the alleged misstatements were being made, senior executives sold more than $97 million worth of their personally held Corcept shares. Specifically, the complaint alleges that Belanoff sold over $25 million, Maduck sold over $27 million, and Guyer sold over $15 million worth of shares during the class period, at what the complaint characterizes as suspiciously timed sales representing a material departure from their prior trading behavior.
Legal Framework and Claims Asserted
The complaint asserts violations of Section 10(b) of the Securities Exchange Act of 1934 and SEC Rule 10b-5 against all defendants, alleging that they made untrue statements of material fact and omitted material facts necessary to make their statements not misleading. The plaintiff also asserts claims under Section 20(a) of the Exchange Act against the officer defendants individually, on the theory that they exercised control over the company and are therefore personally liable for the underlying violations.
The plaintiff alleges that Corcept’s safe harbor warnings for forward-looking statements were ineffective to shield defendants from liability, because the speakers allegedly knew the statements were false when made.
Investors who purchased Corcept common stock during the class period and wish to understand their potential rights are encouraged to seek more information.
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