Corcept Therapeutics Shares Plummet 50% Following FDA Response on Relacorilant

On December 31, 2025, Corcept Therapeutics Incorporated (NASDAQ: CORT) faced a significant financial setback when its stock value fell by 50%, equating to a staggering loss of over $3.6 billion in market capitalization. This drop was triggered by the announcement that the company had received a Complete Response Letter (CRL) from the FDA regarding relacorilant, a proposed treatment for hypercortisolism, commonly referred to as Cushing's syndrome.

The CRL indicates that the FDA was unable to reach a favorable benefit-risk assessment concerning relacorilant without additional evidence of its effectiveness. This news starkly contrasted previous statements from Corcept, which had consistently raised expectations about relacorilant's efficacy and its prospects for FDA approval. The company had assured investors that significant improvements were observed in clinical trials, and that they were progressing well towards securing approval by the end of 2025.

With a sense of optimism, Corcept management had projected that the hypercortisolism business could grow to between $3 billion to $5 billion in annual revenue within three to five years. However, the announcement of the CRL left investors reeling, as the confidence previously expressed by the company quickly turned into doubt.

In response to the market reaction, the national shareholder rights law firm Hagens Berman has initiated an investigation to determine whether Corcept may have misled investors regarding relacorilant's potential and effectiveness. They are particularly focused on assessing whether the company overstated both the drug's efficacy and its commercial growth prospects.

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.”

Prior to the CRL, the company’s communications had led many investors to believe in a bright future for relacorilant that would establish it as a new standard of care. In contrast, the FDA's conclusion has raised immediate concerns among shareholders, prompting them to reassess their positions and losses following the stock’s rapid devaluation.

This situation has not only jeopardized investor confidence but also cast a shadow over the future of Corcept Therapeutics as they navigate the aftermath of this critical announcement. The firm's rapid descent in stock price underscores the volatility in the biopharmaceutical sector and how quickly investor sentiment can shift based on regulatory news.

As the fallout continues, Hagens Berman encourages investors who have experienced significant losses to reach out as they explore their legal options. Investors with non-public information regarding Corcept are urged to consider assisting in the investigation or leveraging the SEC Whistleblower program for potential rewards related to the case.

In conclusion, the recent upheaval experienced by Corcept Therapeutics serves as a reminder of the inherent risks in pharmaceutical investments, particularly when clinical expectations and regulatory feedback diverge dramatically. Investors must now wait and see how the company responds to the FDA's demands for more evidence and what this means for relacorilant’s future in the market.