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biotech/news//MarketScreener
Corcept Therapeutics says it plans to resubmit its new drug application to the FDA.
Corcept Therapeutics will resubmit its NDA for relacorilant, a Cushing's Syndrome treatment.
KEY POINTS
The FDA previously requested more evidence of relacorilant's effectiveness before approval consideration.
Corcept conducted additional analyses of NDA data at the FDA's request.
The company plans to resubmit the NDA in the coming weeks after positive analysis results.
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 [email protected]
(END) Dow Jones Newswires
05-27-26 0858ET