Mirum 获得 zilurgisertib 授权许可；FDA 设定 2026 年 9 月 26 日 PDUFA 日期

Mirum 从 Incyte 获得 zilurgisertib 的全球独家权利，用于 FOP。FDA 已受理 NDA 并授予优先审评，PDUFA 日期为 2026 年 9 月 26 日。该申报由关键性 2 期 PROGRESS 研究支持。

关键事实

申报时间: 2026年5月6日 20:04
事件: PDUFA 日期确定
方向: 积极
公司: MIRMMirum
资产: zilurgisertib
来源: SEC 8-K
可信度: 有来源
日历: FDA 审批决定 (PDUFA) · 2026年9月26日

来源摘录

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

SEC 8-K