Corcept Therapeutics Faces Investor Backlash After FDA Rejection

Corcept Therapeutics US2183521028

Shares of Corcept Therapeutics have plummeted following a devastating regulatory decision from the U.S. Food and Drug Administration (FDA). The agency declined to approve the company's key drug candidate, Relacorilant, for a specific form of hypertension, triggering a collapse in the stock's value and prompting multiple law firms to launch investigations into potential securities fraud.

The immediate catalyst was a Complete Response Letter (CRL) issued by the FDA on December 31, 2025. Regulators concluded that the application for Relacorilant, intended to treat hypertension due to hypercortisolism, could not be approved without additional efficacy data. They determined that a favorable benefit-risk assessment was not possible based on the current submission.

The market's reaction was severe and swift. Corcept's stock price cratered by 50.42%, representing a loss of $35.40 per share. In a single trading session, the biopharmaceutical firm saw an estimated $3.6 billion wiped from its market capitalization. While the equity has since recovered slightly to $38.20, trading volumes surged dramatically during the sell-off.

In the wake of the collapse, prominent legal firms including Hagens Berman and Pomerantz LLP have initiated probes. These investigations are examining whether Corcept misled shareholders regarding Relacorilant's efficacy and commercial prospects. Scrutiny is focused on prior management statements that assured investors the application was "on track for approval by the end of 2025" and that the drug would become the "new standard of care." The adequacy of risk disclosures related to clinical trial data is also under review, especially given the company's previous projection of growing its hypercortisolism business to $3-$5 billion in annual revenue within three to five years.

A Divided Path Forward for Drug Candidate

The future for Relacorilant is now split across different therapeutic applications. Although the primary indication has suffered a significant setback, development for another use continues. The FDA acknowledged that the pivotal GRACE study met its primary endpoint but still demanded more proof of effectiveness.

Market analysts now anticipate a delay of up to three years for the Cushing's syndrome application, with a potential launch not occurring until the first quarter of 2029. However, a separate regulatory milestone remains intact. The Prescription Drug User Fee Act (PDUFA) date of July 11, 2026, for Relacorilant in treating platinum-resistant ovarian cancer was not affected by the recent FDA rejection.

Furthermore, Clarivate's newly published "Drugs to Watch" report continues to list Relacorilant as a therapy with blockbuster potential. This creates a stark contrast between the immediate legal and regulatory crisis and the drug's longer-term, yet highly uncertain, commercial outlook. The company's immediate survival now hangs in the balance as it navigates this dual challenge of restoring regulatory confidence and defending itself against allegations of investor deception.