Why Is CORT Stock Falling Today?

• Corcept had filed an NDA for relacorilant last year as a treatment for patients with hypercortisolism, which leads to a collection of symptoms known as Cushing’s Syndrome.
• The company said that this application was made based on positive results from a GRACE trial, long-term extension studies, and a Phase 2 study in hypercortisolism.
• Corcept stated in its application that patients who received relacorilant showed improvements across a wide range of hypercortisolism-related signs and symptoms.

Shares of Corcept Therapeutics Inc. (CORT) were down more than 35% in Wednesday’s pre-market trade after the U.S. Food and Drug Administration (FDA) said it needs additional evidence of the effectiveness of relacorilant in the treatment of Cushing’s Syndrome.

Corcept stated that the FDA acknowledged that the company’s GRACE trial met its primary endpoint, but said the agency could not reach a favorable benefit-risk assessment for relacorilant.

Corcept had filed a New Drug Application (NDA) for relacorilant last year as a treatment for patients with hypercortisolism, which leads to a collection of symptoms known as Cushing’s Syndrome.

Corcept shares closed more than 12% lower on Tuesday. Retail sentiment on Stocktwits around the company trended in the ‘extremely bullish’ territory at the time of writing.

Meanwhile, Xeris Biopharma Holdings Inc. (XERS) shares gained nearly 6% in Wednesday’s pre-market trade. Corcept’s setback alleviates competitive pressure on Xeris, which offers Recorlev as a prescription medicine for the treatment of high cortisol levels in patients with Cushing’s Syndrome.

Corcept’s New Drug Application

Corcept filed its NDA with the US FDA for relacorilant to treat patients with Cushing’s Syndrome. The company said that this application was made based on positive results from a GRACE trial, long-term extension studies, and a Phase 2 study in hypercortisolism.

The company stated in its application that patients who received relacorilant showed improvements across a wide range of hypercortisolism-related signs and symptoms. Corcept added that there were no serious adverse events in patients taking the currently approved medication.

“We are surprised and disappointed by this outcome,” said Corcept CEO Joseph Belanoff. “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,” he added.

Optimism Around Relacorilant

Earlier this month, UBS analyst Ashwani Verma initiated coverage of Corcept with a ‘neutral’ rating and a price target of $95, according to TheFly. The price target implies an upside of 35% from Tuesday’s closing price.

Verma stated that the CORT stock is already pricing in the optimism around the new launch opportunity in platinum-resistant ovarian cancer, as well as the continued growth in hypercortisolism.

Corcept’s NDA for relacorilant was accepted by the FDA as a treatment for patients with platinum-resistant ovarian cancer, with the deadline set for July 11, 2026.

The deadline for relacorilant as a treatment for Cushing’s Syndrome was set to Dec. 30, 2025.

CORT stock is up 39% year-to-date and 38% over the past 12 months.

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