1차 출처 기록
결정급보완요구서한 (CRL)
Corcept, hypercortisolism 관련 relacorilant에 대해 CRL 수령
FDA가 hypercortisolism에 이차적인 고혈압 치료를 위한 relacorilant NDA에 대해 Complete Response Letter를 발행했습니다. FDA는 GRACE 시험이 1차 평가변수를 충족하고 GRADIENT가 확인적 증거를 제공했음을 인정했으나, 긍정적인 benefit-risk 평가를 위해서는 추가적인 유효성 증거가 필요하다고 결론지었습니다. Corcept는 다음 단계를 결정하기 위해 가능한 한 빨리 FDA와 회의할 계획입니다.
핵심 사실
출처 발췌
EX-99.1 2 d50993dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 CONTACT: Investor inquiries: ir@corcept.com Media inquiries: communications@corcept.com www.corcept.com Corcept Receives Complete Response Letter for Relacorilant as a Treatment for Patients with Hypercortisolism REDWOOD CITY, Calif. (Dec. 31, 2025) — Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company 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, today announced that the U.S. Food and Drug Administration (FDA or the Agency) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for relacorilant as a treatment for patients with hyperte