1차 출처 기록
결정급PDUFA 날짜 확정
Mirum, zilurgisertib 라이선스 인; FDA, 2026년 9월 26일 PDUFA 설정
Mirum은 FOP 치료를 위해 Incyte로부터 zilurgisertib에 대한 전 세계 독점 권리를 인수했습니다. FDA는 NDA를 수락하고 우선 심사(Priority Review)를 부여했으며, PDUFA 날짜는 2026년 9월 26일입니다. 이 신청은 핵심 2상 PROGRESS 연구에 의해 뒷받침됩니다.
핵심 사실
출처 발췌
EX-99.1 2 mirm-20260506xexx991.htm EX-99.1 Document Exhibit 99.1 Mirum Pharmaceuticals Reports First Quarter 2026 Financial Results and Provides Business Update – Q1 2026 net product sales of $159.9 million – 2026 net product sales guidance increased to $660 to $680 million – Volixibat VISTAS Phase 2b study met primary endpoint – Brelovitug Phase 2b portion of AZURE-1 study met primary endpoint – In-licensed exclusive worldwide rights to zilurgisertib (ALK2 inhibitor) for FOP; FDA Priority Review granted with September 26, 2026 PDUFA date – Conference call to provide business updates today, May 6 at 1:30 p.m. PT / 4:30 p.m. ET FOSTER CITY, Calif. – May 6, 2026 - Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leading rare disease company, today reported financial results for the first qua