STAT+: Dispute between Corcept Therapeutics, FDA runs deep

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Source: STAT News

Original: https://www.statnews.com/2026/02/05/corcept-therapeutics-fda-relacorilant-cushin...

Published: Thu, 05 Feb 2026 11:30:00 +0000

The US Food and Drug Administration (FDA) issued a Complete Response Letter to the application for approval of Corcept Therapeutics' experimental drug relacorilant, causing the company's stock to plummet more than 50%.[1] The FDA stated that the clinical data submitted were insufficient to demonstrate a favorable benefit-risk balance.[1] Relacorilant is a selective cortisol modulator that was supposed to moderate the negative effects of excess cortisol while limiting hormonal side effects.[1] The drug was studied not only for the main indication, but also for other serious diseases, including some types of cancer.[1] Relacorilant was among Corcept Therapeutics' most important projects.[1] The company focuses on the development and commercialization of drugs for endocrine and metabolic diseases and has the approved drug Korlym for the treatment of hyperglycemia associated with hypercortisolism.[1]