On December 31, 2025, Corcept filed a Current Report with the Securities Exchange Commission on Form 8-K announcing in a press release that “the U.S. Food and Drug Administration (FDA or the Agency) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for relacorilant as a treatment for patients with hypertension secondary to hypercortisolism.” The press release stated that “[w]hile the FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the company’s GRADIENT trial provided confirmatory evidence, the Agency concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness.”
On this news, Corcept’s stock price fell $35.40 per share, or 50.42%, to close at $34.80 per share on December 31, 2025.
