Record mula sa primary source
Decision-gradeNaitakda ang petsa ng PDUFA
Mirum inililisensya ang zilurgisertib; FDA nagtakda ng Sept 26, 2026 PDUFA
Mirum nakuha ang eksklusibong pandaigdigang karapatan sa zilurgisertib mula sa Incyte para sa FOP. Tinanggap ng FDA ang NDA at binigyan ng Priority Review na may PDUFA date na September 26, 2026. Ang paghahain ay suportado ng pivotal Phase 2 PROGRESS study.
Mahahalagang fact
- Na-file
- May 6, 2026, 08:04 PM
- Kaganapan
- Naitakda ang petsa ng PDUFA
- Direksyon
- Positibo
- Kumpanya
MIRMMirum- Asset
- zilurgisertib
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Desisyon ng FDA (PDUFA) · Set 26, 2026 · Inaprubahan
Sipi mula sa source
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