Mirum 授權引進 zilurgisertib；FDA 設定 2026 年 9 月 26 日 PDUFA

Mirum 從 Incyte 取得 zilurgisertib 的全球獨家權利，用於 FOP。FDA 已受理 NDA 並授予優先審查，PDUFA 日期為 2026 年 9 月 26 日。該申請由關鍵性 Phase 2 PROGRESS 研究支持。

關鍵事實

申報時間: 2026年5月6日下午08:04
事件: PDUFA 日期確定
方向: 正面
公司: MIRMMirum
資產: zilurgisertib
來源: SEC 8-K
可信度: 有出處
行事曆: FDA 審查決定 (PDUFA) · 2026年9月26日

來源摘錄

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