Corcept Therapeutics Faces Market Selloff and Legal Probes Following FDA Rejection of Relacorilant

2026-01-10 companies

San Francisco, Friday, 9 January 2026.
Corcept Therapeutics (NASDAQ: CORT) is under intense pressure after the FDA issued a Complete Response Letter regarding its New Drug Application for relacorilant, a treatment for hypertension caused by hypercortisolism. The regulatory rejection, announced on December 31, 2025, precipitated a massive 50% collapse in share value, effectively erasing $3.6 billion in market capitalization. While the FDA acknowledged some positive trial data, it concluded that additional evidence is required to establish the drug’s effectiveness. Consequently, the company now faces a wave of investigations from shareholder rights law firms, including Hagens Berman and Scott+Scott. These inquiries focus on whether management overstated relacorilant’s clinical efficacy and the commercial prospects of its hypercortisolism business to investors. Analysts have subsequently downgraded price targets, casting doubt on Corcept’s ability to meet its projected revenue goals within the previously stated timeframe.

Regulatory Hurdles and Clinical Data Discrepancies

The FDA’s decision to issue a Complete Response Letter stems from a critical review of Corcept’s clinical data for relacorilant, a drug intended to treat high blood pressure associated with Cushing’s syndrome [3]. While the agency acknowledged that the pivotal GRACE trial successfully met its primary endpoint and that the GRADIENT trial offered confirmatory evidence, regulators deemed these findings insufficient to support approval at this stage [5][6]. Crucially, the FDA noted that one of the company’s Phase III trials failed to demonstrate a statistically significant benefit compared to a placebo [3]. Consequently, the agency concluded that a favorable benefit-risk profile could not be established without Corcept providing additional evidence of the drug’s effectiveness [4][6].

Market Reaction and Analyst Downgrades

The financial impact of the rejection was immediate and severe. On December 31, 2025, Corcept’s stock price plummeted by approximately 50%, closing at $34.80 per share [3][4]. This decline represented a drop of $35.40 per share, wiping out an estimated $3.6 billion in market capitalization in a single trading session [1][6]. In response to the heightened uncertainty, analysts at Truist Securities drastically adjusted their outlook, lowering their price target for the company from $135 to $50, a decrease of -62.963 percent [3]. The firm warned investors that the FDA’s request for more data could necessitate additional trials, significantly dimming the commercial outlook for the drug in the Cushing’s syndrome market [3].

Legal Scrutiny Intensifies

Following the collapse in share value, Corcept is now the subject of multiple investigations by shareholder rights law firms, including Hagens Berman, Scott+Scott, The Schall Law Firm, and Bragar Eagel & Squire, P.C. [1][4][5][6]. These legal inquiries are focused on whether the company’s leadership issued false or misleading statements regarding relacorilant’s clinical efficacy and the commercial prospects of its hypercortisolism business [1][5]. Specifically, Hagens Berman is investigating whether management’s previous claims—that the company was on track to grow its hypercortisolism business revenue to between $3 billion and $5 billion within three to five years—lacked a reasonable basis given the clinical data available to them [1].

Strategic Implications and Future Outlook

Despite the regulatory setback, Corcept CEO Joseph Belanoff has expressed confidence in finding a path forward, stating the company plans to meet with the FDA soon to discuss the application [3]. However, the rejection challenges Corcept’s strategy to diversify its revenue stream beyond its existing Korlym franchise [2]. The company had projected reaching $2.0 billion in revenue and $743 million in earnings by 2028, a target that relied on an earnings increase of approximately 462.879 percent from its current base of $132 million [2]. Investors are now looking toward July 11, the expected conclusion date for the FDA’s review of relacorilant for ovarian cancer, which remains a critical upcoming milestone for the company [3].

Sources

Pharmaceutical Regulation Stock Crash