Corcept Therapeutics Faces Securities Class Action After FDA Rejection, Patent Loss

Lawsuit alleges company concealed repeated FDA warnings about insufficient data for lead drug candidate

Mar. 16, 2026 at 11:06pm by Ben Kaplan

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

Why it matters

The lawsuit highlights the potential consequences for pharmaceutical companies that fail to disclose negative information from regulatory agencies, even as they promote the progress of their drug pipelines. The case could have broader implications for investor trust and transparency in the biotech industry.

The details

The complaint alleges that during pre-submission meetings in 2024 and early 2025, the FDA warned Corcept on several occasions that its clinical data lacked sufficient evidence of effectiveness to support a New Drug Application (NDA) for relacorilant. However, the company continued to tout the positive Phase 3 results, allegedly misleading investors. On December 31, 2025, Corcept revealed it had received a Complete Response Letter from the FDA, which concluded the agency 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 about insufficient data 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 biopharmaceutical company focused on developing drugs for severe metabolic, oncologic, and psychiatric disorders.

Hagens Berman

A global plaintiffs' rights complex litigation firm focusing on corporate accountability.

Reed Kathrein

The Hagens Berman partner leading the 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 is April 21, 2026.

The takeaway

This case highlights the importance of pharmaceutical companies fully disclosing regulatory feedback, even if it is negative, to maintain investor trust and transparency. The significant stock price drop following Corcept's disclosure of the FDA's rejection underscores the potential consequences for companies that allegedly conceal unfavorable information from investors.