Corcept’s Shares Sink as FDA Won’t Approve Treatment for Hypercortisolism

Rare Daily Staff

The U.S. Food and Drug Administration has notified Corcept Therapeutics that it will not approve its experimental therapy relacorilant as a treatment for patients with hypertension secondary to hypercortisolism.

The agency acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the company’s GRADIENT trial provided confirmatory evidence, but it concluded that it could not reach a favorable benefit-risk assessment for relacorilant without additional evidence of effectiveness. Shares of Corcept fell nearly 50 percent to $36.41 in midday trading.

“We are surprised and disappointed by this outcome,” said Joseph Belanoff, Corcept’s CEO. “I am confident we will find a way to get relacorilant to the patients it could help. We will meet with the FDA as soon as possible to discuss the best path forward.”

Hypercortisolism, which is caused by an excessive amount of cortisol in the body, can lead to weight gain, insulin resistance, diabetes, high blood pressure, mood changes, and other complications. Relacorilant is an oral, selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. Corcept is developing relacorilant in endogenous hypercortisolism and a variety of other serious disorders, including ovarian cancer. The FDA and European Commission have granted relacorilant orphan drug designation for the treatment of hypercortisolism. In addition, the EC has granted orphan drug designation to it for the treatment of ovarian cancer.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026, for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. Corcept also recently submitted a Marketing Authorization Application to the European Medicines Agency for relacorilant to treat patients with platinum-resistant ovarian cancer.