Corcept Therapeutics Hit with Securities Lawsuit After FDA Rejection

Hagens Berman files class action alleging Corcept concealed FDA warnings about insufficient data for lead drug candidate

Mar. 13, 2026 at 3:49pm by Ben Kaplan

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Corcept Therapeutics, a pharmaceutical company, is facing a securities class action lawsuit filed by Hagens Berman following the FDA's rejection of the company's lead drug candidate, relacorilant. The lawsuit alleges that Corcept's management concealed repeated warnings from the FDA about insufficient clinical data to support the drug's approval, while publicly touting the drug's progress. The lawsuit covers a class period from October 2024 to December 2025, during which Corcept's stock price plummeted 50% after the company disclosed the FDA's Complete Response Letter rejecting the drug.

Why it matters

This case highlights the risks pharmaceutical companies face when they are accused of misleading investors about the status of their drug development pipelines. The lawsuit alleges a classic 'information gap' between what Corcept told the public and what the FDA was reportedly telling the company privately, which resulted in a significant loss of shareholder value.

The details

The lawsuit, filed by Hagens Berman, alleges that throughout the class period, Corcept's management made materially false and misleading statements by failing to disclose that the FDA had repeatedly warned the company during pre-submission meetings in 2024 and early 2025 that its clinical data lacked sufficient evidence of effectiveness for relacorilant. Despite these warnings, the lawsuit claims Corcept continued to tout positive Phase 3 results, misleading investors. On December 31, 2025, Corcept revealed it had received a Complete Response Letter from the FDA, which concluded it could not arrive at a favorable benefit-risk assessment for relacorilant due to an 'insufficient' evidentiary record. This disclosure caused Corcept's stock price to plummet 50% in a single day.

  • In 2024 and early 2025, the FDA warned Corcept on several occasions that its clinical data lacked sufficient evidence of effectiveness for relacorilant.
  • On December 31, 2025, Corcept revealed it had received a Complete Response Letter from the FDA rejecting relacorilant.

The players

Corcept Therapeutics Incorporated

A pharmaceutical company that develops and commercializes drugs for the treatment of severe metabolic, oncologic, and psychiatric disorders.

Hagens Berman

A national shareholder rights law firm that filed the securities class action lawsuit against Corcept Therapeutics.

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What they’re saying

“The heart of the Corcept case is a classic 'information gap' between what the company told the public and what the FDA was reportedly telling the company behind closed doors.”

— Reed Kathrein, Hagens Berman partner leading the firm's investigation

What’s next

The deadline for investors in Corcept to move for Lead Plaintiff in the pending securities class action is April 21, 2026.

The takeaway

This case highlights the importance of pharmaceutical companies being transparent with investors about the status of their drug development pipelines, especially when facing regulatory scrutiny. The significant stock price drop following Corcept's disclosure of the FDA's rejection underscores the financial risks for companies accused of concealing material information from investors.