Corcept Therapeutics Faces Regulatory Setback as FDA Rejects Relacorilant

On December 31, 2025, the U.S. Food and Drug Administration (FDA) declined to approve Corcept Therapeutics Inc.'s drug, relacorilant, for the treatment of hypertension secondary to hypercortisolism, commonly known as Cushing's syndrome. The FDA's complete response letter indicated that the agency could not reach a favorable benefit-risk assessment without additional evidence of the drug's effectiveness. Following this announcement, Corcept's shares plummeted nearly 50%, closing at approximately $36.41, resulting in a market capitalization loss of nearly $3.5 billion.

Corcept stock plunges 50% after FDA rejects relacorilant in Cushing’s-related hypertensionCorcept Therapeutics (CORT) stock dives nearly 50% after FDA rejects relacorilant — what investors watch nextReutersCityLab

Hypercortisolism is characterized by prolonged exposure to high cortisol levels, leading to symptoms such as high blood pressure, diabetes, and muscle weakness. Relacorilant is designed as a selective glucocorticoid receptor antagonist, aiming to block cortisol's effects while minimizing off-target hormonal interactions. Corcept had previously reported that relacorilant met its primary endpoint in a late-stage trial, yet the FDA's decision reflects concerns regarding the robustness of the data provided.

ReutersCorcept stock plunges 50% after FDA rejects relacorilant in Cushing’s-related hypertensionCorcept Therapeutics (CORT) stock dives nearly 50% after FDA rejects relacorilant — what investors watch nextCityLab

The FDA's rejection has raised significant concerns among investors and analysts regarding Corcept's future growth prospects. Analysts from Truist noted that the request for additional data may necessitate further trials, which could delay the drug's market entry and increase development costs. Wolfe Research downgraded Corcept's stock rating to Underperform, setting a price target of $30, while Truist maintained a buy rating but reduced its target from $135 to $50.

Corcept stock plunges 50% after FDA rejects relacorilant in Cushing’s-related hypertension

Joseph Belanoff, CEO of Corcept, expressed surprise and disappointment at the FDA's decision, stating that the company plans to meet with the FDA to discuss the next steps. Corcept is also pursuing relacorilant for other indications, including ovarian and prostate cancer, with a PDUFA date set for July 11, 2026, for the ovarian cancer application.

Corcept Therapeutics (CORT) stock dives nearly 50% after FDA rejects relacorilant — what investors watch next

Despite the acknowledgment of some positive trial results, analysts have raised concerns about the small size and design of the studies supporting relacorilant's efficacy. Piper Sandler analysts highlighted these issues, suggesting that the initial success on the primary endpoint might not be sufficient to overcome the FDA's reservations.

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While the FDA recognized the pivotal GRACE trial's success, it emphasized the need for more comprehensive evidence to support the drug's approval. This discrepancy between the trial results and the FDA's assessment has left investors uncertain about the path forward for relacorilant.

Corcept Therapeutics (CORT) stock dives nearly 50% after FDA rejects relacorilant — what investors watch next

As Corcept navigates this regulatory setback, investors will be closely monitoring the company's discussions with the FDA and any potential requirements for new trials. The focus will also shift to the ovarian cancer filing and how Corcept plans to address the FDA's concerns regarding relacorilant's effectiveness in treating hypertension related to hypercortisolism.

Corcept stock plunges 50% after FDA rejects relacorilant in Cushing’s-related hypertensionCorcept Therapeutics (CORT) stock dives nearly 50% after FDA rejects relacorilant — what investors watch nextReutersCityLab