The U.S. Food and Drug Administration issued a Complete Response Letter on December 31 2025, rejecting Corcept Therapeutics’ application for relacorilant in the treatment of hypercortisolism. The letter noted that while the pivotal GRACE trial met its primary endpoint, the agency could not establish a favorable benefit‑risk profile without additional evidence of effectiveness.
The GRACE study demonstrated a statistically significant reduction in cortisol levels, but the FDA cited concerns about the durability of the response and the lack of long‑term safety data. The agency’s request for more data underscores the need for a broader evidence base before relacorilant can be approved as a therapeutic option for Cushing’s syndrome.
Corcept’s chief executive, Joseph K. Belanoff, said the company is disappointed but remains committed to patients. He announced plans to meet with FDA reviewers to discuss a path forward and to submit additional clinical data. The statement signals that the company will pursue a revised submission rather than abandon the program.
Financially, Corcept is a sizable biopharma player with a market capitalization of $7.38 billion and $741 million in revenue for the 12 months ending September 30 2025. Gross margin sits at 98.2 %, but operating margin has slipped over the past five years, reflecting investment in pipeline development and regulatory costs. The company’s balance sheet is strong, with a debt‑to‑equity ratio of 0.01 and ample cash reserves to weather the setback.
The CRL triggered a sharp sell‑off in Corcept’s shares, with analysts downgrading the stock and revising price targets downward. The market reaction reflects the loss of a key growth driver and the uncertainty surrounding the company’s ability to generate near‑term revenue from relacorilant.
Beyond hypercortisolism, Corcept is pursuing relacorilant for platinum‑resistant ovarian cancer, with a PDUFA date of July 11 2026. Positive data from that trial could mitigate the impact of the hypercortisolism rejection, but the company’s valuation will now hinge on the outcome of the ovarian cancer application and its ability to diversify its pipeline.
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