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

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

Mar. 13, 2026 at 3:37pm by Ben Kaplan

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A securities class action lawsuit has been filed against Corcept Therapeutics (NASDAQ: CORT) alleging the company misled investors about the prospects of its lead drug candidate relacorilant. The lawsuit claims Corcept concealed repeated FDA warnings that the clinical data lacked sufficient evidence of effectiveness, while publicly touting positive Phase 3 results. When Corcept later revealed it had received a Complete Response Letter from the FDA rejecting the drug, the company's stock price plummeted 50% in a single day, erasing nearly $2.5 billion in market value.

Why it matters

The case highlights the risks pharmaceutical companies face when they are accused of concealing negative information from regulators and investors. Corcept is a prominent biotech firm, and this lawsuit could have broader implications for how drug developers communicate with the FDA and the public about the status of their pipelines.

The details

The lawsuit, filed by the Allegheny County Employees' Retirement System, alleges that throughout the class period from October 2024 to December 2025, Corcept made materially false and misleading statements about relacorilant. The complaint claims the company failed to disclose that during pre-submission meetings, the FDA had warned Corcept on several occasions that the clinical data lacked sufficient evidence of effectiveness to support a New Drug Application. Despite these warnings, the lawsuit alleges Corcept continued to tout the positive Phase 3 results for relacorilant.

  • 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 rejecting relacorilant due to an "insufficient" evidentiary record.
  • On December 31, 2025, Corcept's stock price plummeted 50% from $70.20 to $34.80, erasing nearly $2.5 billion in market value.

The players

Corcept Therapeutics Incorporated

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

Hagens Berman

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

Allegheny County Employees' Retirement System

The lead plaintiff in the securities class action lawsuit against Corcept.

Reed Kathrein

The Hagens Berman partner leading the investigation into Corcept.

U.S. Food and Drug Administration (FDA)

The federal agency responsible for regulating and supervising the safety of drugs and medical devices.

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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

What’s next

The judge in the case will decide on April 21, 2026 whether to appoint the Allegheny County Employees' Retirement System as the lead plaintiff in the securities class action lawsuit.

The takeaway

This case highlights the importance of transparency between pharmaceutical companies and regulators, as well as the risks companies face when they are accused of concealing negative information from investors. The outcome of this lawsuit could have broader implications for how drug developers communicate with the FDA and the public about the status of their drug pipelines.