Corcept Says FDA Rejected Hypercortisolism Drug Application on Benefit-Risk Concerns
By Adriano Marchese
Corcept Therapeutics said the Food and Drug Administration requires more evidence of effectiveness beyond recent positive trial data to support its application for its treatment for hypercortisolism.
The commercial-stage company said on Wednesday the U.S. health regulator couldn't arrive at a favorable benefit-risk assessment for relacorilant, the drug proposed to treat patients with hypertension secondary to hypercortisolism.
The response came by way of a complete response letter by the regulator.
The FDA gave its decision despite acknowledging Corcept's trial having met its primary endpoint and that data from another trial provided confirmatory evidence.
Chief Executive Joseph Belanoff said the company will meet with regulators as soon as possible to discuss the best way forward.
Write to Adriano Marchese at adriano.marchese@wsj.com
(END) Dow Jones Newswires
December 31, 2025 09:21 ET (14:21 GMT)
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