Corcept Therapeutics Incorporated
| Company Name | Corcept Therapeutics Incorporated |
| Stock Symbol | CORT |
| Class Period | October 31, 2024 to December 30, 2025 |
| Lead Plaintiff Motion Deadline | April 21, 2026 |
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Background
On December 31, 2025, Corcept announced the U.S. Food and Drug Administration (“FDA”) had issued a Complete Response Letter (“CRL”), declining to approve the Company’s New Drug Application (“NDA”) for relacorilant as a treatment for patients with hypercortisolism, stating that the FDA had “concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness.” The Company stated it was “surprised and disappointed by this outcome.”
On this news, Corcept’s stock price fell $35.40 per share, or 50.42%, to close at $34.80 per share on December 31, 2025.
Then, on January 30, 2026, the FDA published an updated CRL regarding Corcept’s relacorilant NDA. The letter revealed that “[d]uring the pre-submission meetings, [the FDA] informed [Corcept] on several occasions of [its] concerns about the adequacy of the clinical development program to assess the effect of relacorilant” and “to expect significant review issues if [Corcept] were to submit [its] application.”
The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) the FDA had told Corcept that it had concerns about the adequacy of the program assessing relacorilant’s effectiveness in treating hypertension in patients with hypercortisolism, including the design of its pivotal “GRACE” trial study; (2) the FDA had further told Corcept to expect significant issues with the review if Corcept was to submit the NDA; and (3) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.
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