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Corcept Plans to Resubmit Cushing's Syndrome Drug Application to FDA

Provided by Dow Jones May 27, 2026, 12:58:00 PM

By Connor Hart

Corcept Therapeutics said it plans to resubmit its new drug application, or NDA, to the Food and Drug Administration for its treatment for hypercortisolism, also known as Cushing's Syndrome.

The resubmission comes after the FDA in December said it required more evidence of effectiveness to support the application of the drug, called relacorilant.

"Following issuance of its complete response letter, the FDA asked us to conduct additional analyses of our NDA data," Corcept Chief Executive Joseph Belanoff said Wednesday. "Based on the positive outcome of those analyses and the productive tenor of our discussions, we plan to resubmit our NDA in the coming weeks."

He added that Corcept has appreciated the FDA's continued engagement throughout the process.

Shares climbed 6%, to $64, in premarket trading.

Write to Connor Hart at connor.hart@wsj.com

(END) Dow Jones Newswires

May 27, 2026 08:58 ET (12:58 GMT)

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