Corcept Therapeutics Faces Securities Class Action After FDA Rejection

Lawsuit alleges Corcept concealed FDA warnings about insufficient data for lead drug candidate relacorilant

Mar. 16, 2026 at 6:06pm by Ben Kaplan

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National shareholder rights law firm Hagens Berman has filed a securities class action lawsuit against Corcept Therapeutics (NASDAQ: CORT) on behalf of investors who purchased the company's stock between October 31, 2024 and December 30, 2025. The lawsuit alleges that Corcept management concealed repeated FDA warnings about insufficient data to support the New Drug Application for the company's lead drug candidate relacorilant, while publicly touting the drug's Phase 3 results.

Why it matters

The case highlights the risks pharmaceutical companies face when they fail to fully disclose regulatory challenges with their drug pipelines. Corcept's stock price plummeted nearly 50% after the company revealed it had received a Complete Response Letter from the FDA, concluding the data for relacorilant was "insufficient" to support approval. This serves as a cautionary tale for investors about the importance of transparency from biotech firms regarding the status of their drug development programs.

The details

The lawsuit alleges that during pre-submission meetings in 2024 and early 2025, the FDA warned Corcept on several occasions that its clinical data for relacorilant lacked sufficient evidence of effectiveness to support a New Drug Application. However, the company continued to tout the positive Phase 3 results for the drug, despite allegedly knowing the FDA viewed the data as fundamentally flawed. On December 31, 2025, Corcept revealed it had received the 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 nearly 50% in a single day, erasing $2.5 billion in market capitalization.

  • During pre-submission meetings in 2024 and early 2025, the FDA warned Corcept that its clinical data for relacorilant lacked sufficient evidence of effectiveness.
  • On December 31, 2025, Corcept revealed it had received a Complete Response Letter from the FDA, concluding the data for relacorilant was "insufficient" to support approval.

The players

Corcept Therapeutics Incorporated

A biopharmaceutical company focused on developing drugs for the treatment of severe metabolic, oncologic, and psychiatric disorders.

Hagens Berman

A global plaintiffs' rights complex litigation firm focusing on corporate accountability and representing investors, whistleblowers, workers, and consumers in cases achieving real results for those harmed by corporate negligence and other wrongdoings.

Reed Kathrein

The Hagens Berman partner leading the firm's investigation into the Corcept case.

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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, Partner, Hagens Berman

What’s next

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

The takeaway

This case highlights the importance of pharmaceutical companies being fully transparent with investors about the status of their drug development pipelines, especially regarding any regulatory challenges or concerns raised by the FDA. Investors should be wary of companies that appear to be concealing unfavorable information from regulators.