Corcept Therapeutics (CORT) Faces Investor Scrutiny Following FDA Setback
On December 31, 2025, investors in Corcept Therapeutics Incorporated (NASDAQ: CORT) experienced a dramatic decline in their investment as the company's stock plummeted by 50%. This sharp decrease came after the company announced it had received a Complete Response Letter (CRL) from the FDA regarding its proposed treatment for patients suffering from hypercortisolism, also known as Cushing's syndrome, specifically the drug relacorilant.
Implications of the Complete Response Letter
The CRL issued by the FDA indicates that the agency was unable to reach a favorable benefit-risk assessment for relacorilant without further evidence of its effectiveness. As a result, investors are questioning whether Corcept may have inaccurately portrayed the drug's potential efficacy and the commercial prospects associated with it.
The immediate market reaction was severe, with shares of CORT decreasing by more than $35, leading to a loss of over $3.6 billion in market capitalization in just one day.
Previous Promises and Investor Confidence
Prior to this announcement, Corcept had consistently communicated its confidence in relacorilant. The company claimed that patients involved in clinical trials "exhibited clinically meaningful improvements in a wide range of hypercortisolism signs and symptoms." Additionally, management expressed optimism that the new drug application for relacorilant was advancing towards a potential approval by the end of 2025.
Corcept's management set ambitious revenue targets, forecasting that the hypercortisolism business could grow from $3 billion to $5 billion in annual revenues within three to five years. These assertions have now come under scrutiny following the FDA's recent communication.
Investigation by Hagens Berman
The fallout from the CRL has prompted national shareholder rights law firm Hagens Berman to initiate an investigation into whether CORT misled investors concerning relacorilant's effectiveness. Reed Kathrein, a partner at Hagens Berman, stated, "We're focused on whether Corcept may have overstated relacorilant's efficacy and, if so, whether it may have also overstated its hypercortisolism business commercial and growth prospects."
Hagens Berman is urging investors who incurred substantial losses in their investments in Corcept to come forward and discuss their rights and options. Interested parties can reach out to the firm either through their website at www.hbsslaw.com/investor-fraud/cort or by calling 844-916-0895.
Whistleblower Opportunities
Individuals with non-public information about Corcept are encouraged to consider providing information that may assist in the investigation. Additionally, whistleblowers may benefit from the SEC Whistleblower program, which offers awards of up to 30% for original information leading to successful recoveries.
About Hagens Berman
Hagens Berman is a prominent plaintiffs' rights complex litigation firm that advocates for corporate accountability. The firm has successfully represented investors, whistleblowers, workers, and consumers, achieving significant legal victories. With over $2.9 billion in recoveries to date, Hagens Berman continues to prioritize the welfare of those harmed by corporate malfeasance.
For more information on their ongoing investigations or to stay updated with the latest news, follow Hagens Berman at @ClassActionLaw.