Corcept Therapeutics (CORT) Suffers Major Stock Drop Following FDA Complete Response Letter
Investors in Corcept Therapeutics Incorporated (NASDAQ: CORT) faced a devastating blow on December 31, 2025, as the company’s shares plummeted by 50%. This steep decline came after the announcement of a complete response letter (CRL) from the FDA regarding their proposed treatment for hypercortisolism, known as relacorilant. The unexpected regulatory setback has prompted Hagens Berman, a national law firm specializing in shareholder rights, to initiate an investigation into the potential misrepresentation of relacorilant’s efficacy and market potential.
Investigation Launched by Hagens Berman
Following the significant market reaction, Hagens Berman is urging investors who have suffered substantial losses due to the recent developments to come forward and discuss their legal options. The firm highlights the importance of addressing whether Corcept misled stakeholders regarding relacorilant's effectiveness and its commercial prospects moving forward.
For assistance related to the investigation, investors can contact Hagens Berman at CORT@hbsslaw.com or by calling 844-916-0895.
Details Surrounding the FDA Complete Response Letter
Historically, Corcept has been optimistic about relacorilant, asserting that clinical trials demonstrated “clinically meaningful improvements in a wide range of hypercortisolism signs and symptoms.” Furthermore, the company indicated that their new drug application for relacorilant was well on its way to FDA approval by the end of 2025. Management expressed aspirations of growing their hypercortisolism business from an annual revenue of $3 billion to $5 billion within three to five years.
However, on December 31, 2025, Corcept disclosed that the FDA’s CRL indicated a need for additional evidence of efficacy before a favorable benefit-risk assessment could be made. Reports suggested that although investigators noted that loss of blood pressure control was significantly lower in the relacorilant group compared to placebo, the data was insufficient to satisfy the FDA’s requirements.
Market Impact and Future Implications
The announcement resulted in a dramatic loss for investors, with Corcept's stock price dropping over $35 per share, effectively wiping out more than $3.6 billion in market capitalization in just one day. Reed Kathrein, a partner at Hagens Berman overseeing the investigation, stated, “Our focus is on whether Corcept may have overstated relacorilant’s efficacy and if so, whether it may have also exaggerated its commercial potential for hypercortisolism.”
Whistleblower Opportunities
Additionally, individuals possessing non-public information regarding Corcept are encouraged to explore their options in supporting the investigation. Whistleblowers may qualify for rewards of up to 30% of any successful recovery made by the SEC under the new whistleblower program.
For further information, potential whistleblowers can reach out to Reed Kathrein at 844-916-0895 or via email at CORT@hbsslaw.com.
About Hagens Berman
Hagens Berman is a leading global plaintiffs’ rights complex litigation firm dedicated to ensuring corporate accountability. The firm has successfully represented investors, whistleblowers, workers, and consumers in various cases of corporate misconduct, recovering over $2.9 billion for harmed parties. For more information on their services and successes, visit hbsslaw.com and follow updates via their social media handle @ClassActionLaw.