Catatan sumber primer
PenentuTanggal PDUFA ditetapkan
Mirum melisensikan zilurgisertib; FDA tetapkan PDUFA 26 September 2026
Mirum memperoleh hak eksklusif di seluruh dunia untuk zilurgisertib dari Incyte untuk FOP. FDA telah menerima NDA dan memberikan Tinjauan Prioritas dengan tanggal PDUFA 26 September 2026. Pengajuan didukung oleh studi Phase 2 PROGRESS yang pivotal.
Fakta utama
- Diajukan
- 6 Mei 2026, 20.04
- Peristiwa
- Tanggal PDUFA ditetapkan
- Arah
- Positif
- Perusahaan
MIRMMirum- Aset
- zilurgisertib
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
- Kalender
- Keputusan FDA (PDUFA) · 26 Sep 2026
Kutipan sumber
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