Corcept Therapeutics Faces Scrutiny Amid FDA Warning on New Drug Application
On January 30, 2026, Corcept Therapeutics (NASDAQ: CORT) experienced a significant downturn when reports surfaced regarding warnings issued by the FDA concerning its proposed treatment for hypercortisolism, known as relacorilant. The FDA cautioned Corcept on multiple occasions against submitting its drug application, leading to a swift decline in stock prices. Investors watched in dismay as the value of Corcept shares fell by 17%, equivalent to a loss of $7.81 per share during that trading day.
This setback follows a problematic end of the previous year, when the company disclosed receiving a complete response letter (CRL) from the FDA on December 31, 2025. This letter indicated that the FDA was unable to approve the application without more evidence supporting the drug's effectiveness. As a result of this announcement, Corcept's share value had already plummeted by 50%, erasing considerable market capitalization and signaling major investor concerns.
The law firm Hagens Berman, known for defending investors' rights, has initiated an investigation into whether Corcept misled its shareholders regarding relacorilant’s effectiveness and the commercial potential of the drug. The firm has urged investors who have experienced substantial losses to come forward and share their experiences, ensuring they are informed of their rights during these turbulent times.
In past communications, Corcept had strongly highlighted the promising outcomes of its clinical trials, claiming that patients showed meaningful improvements in various symptoms associated with hypercortisolism. Management previously projected that the new drug application would advance toward approval by the end of 2025, with aspirations to grow the hypercortisolism segment to an impressive $5 billion in annual revenue within three to five years.
The dramatic turn of events has raised questions, especially following the revelation on January 30 that the FDA had explicitly warned Corcept about potential significant review issues related to its application. Investors have now witnessed a staggering cumulative loss of approximately $3.2 billion in market capitalization since December 30.
The CEO of Corcept, Joseph K. Belanoff, expressed surprise and disappointment over the unexpected outcome of the FDA's reviews. However, skepticism regarding the company’s earlier statements has emerged, particularly concerning its communication with the FDA and the potential overstatement of relacorilant's commercial prospects.
Hagens Berman’s investigation has expanded to encompass not just whether Corcept potentially misled investors about relacorilant’s efficacy, but also whether the company conveyed complete and accurate information regarding its FDA communications. If it is determined that misleading information was provided, the firm will analyze the scope of potential damages suffered by investors.
For those investors who feel they have been wronged or possess pertinent information regarding the investigation, they are encouraged to reach out to Hagens Berman directly. The law firm is actively pursuing the notion that whistleblowers with insider knowledge might significantly contribute to revealing the truths behind the currently unclear circumstances surrounding Corcept. Any actionable information could lead to rewards under the SEC Whistleblower Program.
Hagens Berman is a respected name in corporate accountability, having recovered over $2.9 billion for clients affected by corporate misconduct. Their rigorous approach aims to ensure that shareholders receive just treatment in light of unfolding circumstances, making it imperative for affected investors to stay informed as developments continue to emerge in the case against Corcept Therapeutics.
This setback follows a problematic end of the previous year, when the company disclosed receiving a complete response letter (CRL) from the FDA on December 31, 2025. This letter indicated that the FDA was unable to approve the application without more evidence supporting the drug's effectiveness. As a result of this announcement, Corcept's share value had already plummeted by 50%, erasing considerable market capitalization and signaling major investor concerns.
The law firm Hagens Berman, known for defending investors' rights, has initiated an investigation into whether Corcept misled its shareholders regarding relacorilant’s effectiveness and the commercial potential of the drug. The firm has urged investors who have experienced substantial losses to come forward and share their experiences, ensuring they are informed of their rights during these turbulent times.
In past communications, Corcept had strongly highlighted the promising outcomes of its clinical trials, claiming that patients showed meaningful improvements in various symptoms associated with hypercortisolism. Management previously projected that the new drug application would advance toward approval by the end of 2025, with aspirations to grow the hypercortisolism segment to an impressive $5 billion in annual revenue within three to five years.
The dramatic turn of events has raised questions, especially following the revelation on January 30 that the FDA had explicitly warned Corcept about potential significant review issues related to its application. Investors have now witnessed a staggering cumulative loss of approximately $3.2 billion in market capitalization since December 30.
The CEO of Corcept, Joseph K. Belanoff, expressed surprise and disappointment over the unexpected outcome of the FDA's reviews. However, skepticism regarding the company’s earlier statements has emerged, particularly concerning its communication with the FDA and the potential overstatement of relacorilant's commercial prospects.
Hagens Berman’s investigation has expanded to encompass not just whether Corcept potentially misled investors about relacorilant’s efficacy, but also whether the company conveyed complete and accurate information regarding its FDA communications. If it is determined that misleading information was provided, the firm will analyze the scope of potential damages suffered by investors.
For those investors who feel they have been wronged or possess pertinent information regarding the investigation, they are encouraged to reach out to Hagens Berman directly. The law firm is actively pursuing the notion that whistleblowers with insider knowledge might significantly contribute to revealing the truths behind the currently unclear circumstances surrounding Corcept. Any actionable information could lead to rewards under the SEC Whistleblower Program.
Hagens Berman is a respected name in corporate accountability, having recovered over $2.9 billion for clients affected by corporate misconduct. Their rigorous approach aims to ensure that shareholders receive just treatment in light of unfolding circumstances, making it imperative for affected investors to stay informed as developments continue to emerge in the case against Corcept Therapeutics.
Topics Health）
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