Corcept Therapeutics Stock Sinks On FDA Setback For Relacorilant

Corcept Therapeutics Incorporated (NASDAQ:CORT) stock tumbled Wednesday after the FDA rejection for relacorilant.

The commercial-stage company is engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic, and neurologic disorders by modulating the effects of the hormone cortisol.

The U.S. Food and Drug Administration (FDA) on Wednesday issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for relacorilant for hypertension secondary to hypercortisolism.

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Hypertension is a very common feature of Cushing’s syndrome (hypercortisolism), caused by excess cortisol mimicking mineralocorticoids, increasing vascular resistance, and remodeling blood vessels, leading to higher blood pressure.

Hypercortisolism is a medical term for having too much cortisol (stress hormone) in the body, leading to Cushing’s Syndrome.

Clinical Trial Data

While 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 FDA concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness.

In October 2024, the company said the 22-week Phase 3 GRADIENT study supports the GRACE trial by providing further evidence of relacorilant’s efficacy and safety profile.

In May 2024, Corcept Therapeutics announced that the GRACE Phase 3 trial of relacorilant in patients with hypercortisolism (Cushing’s syndrome) met its primary endpoint.

Management Commentary

“We are surprised and disappointed by this outcome…We will meet with the FDA as soon as possible to discuss the best path forward,” said Joseph Belanoff, Corcept’s CEO.

CORT Price Action: Corcept Therapeutics shares were down 41.25% at $41.24 during premarket trading on Wednesday. The stock is trading at a new 52-week low, according to Benzinga Pro data.

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