Corcept Resubmits Relacorilant NDA for Cushing's Syndrome

Regulation Impact 4

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Summary · why it matters

Corcept Therapeutics has resubmitted its new drug application for relacorilant to the FDA as a treatment for Cushing's syndrome. The company expects a six-month review period and included additional data analyses requested by the FDA after a complete response letter in December 2025. The resubmission is supported by positive results from the GRACE study, the phase III GRADIENT study, and long-term extension data. Corcept shares have soared 134.9% year to date, while the industry has declined 9.1%.

Corcept Therapeutics Incorporated ▲

Impact on stocks 4

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Corcept Therapeutics Incorporated

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Corcept resubmitted relacorilant NDA for Cushing's syndrome after FDA complete response letter, with positive trial data and expected six-month review.