1차 출처 기록
결정급PDUFA 날짜 연장
Corcept, 쿠싱 증후군에 대한 relacorilant NDA 재제출; PDUFA 2026년 12월 17일
Corcept는 2026년 6월 쿠싱 증후군에 대한 relacorilant NDA를 재제출했습니다. FDA는 2026년 12월 17일의 PDUFA 목표 조치일을 지정하여 해당 자산에 대한 확실한 규제 결정 일정을 제공했습니다.
핵심 사실
출처 발췌
EX-99.1 2 cort072926ex991pressrelease.htm EX-99.1 Document EXHIBIT 99.1 Corcept Therapeutics Announces Second Quarter Financial Results and Provides Corporate Update • Revenue of $256.1 million, a 32 percent increase over the same period in 2025 ◦ Korlym ® and authorized generic product revenue of $208.6 million ◦ Lifyorli ™ product revenue of $47.6 million • Increase in 2026 revenue guidance to $1.1 – $1.2 billion • Net income of $43.0 million, compared to $35.1 million in second quarter 2025 • Cash and investments of $544.6 million at June 30, 2026 REDWOOD CITY, Calif., (July 29, 2026) – 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