Registro de fonte primária
Nível de decisãoData PDUFA definida
Mirum licencia zilurgisertib; FDA define PDUFA para 26 de setembro de 2026
Mirum adquiriu direitos exclusivos mundiais para zilurgisertib da Incyte para FOP. A FDA aceitou a NDA e concedeu Revisão Prioritária com data PDUFA de 26 de setembro de 2026. O registro é suportado pelo estudo pivotal Phase 2 PROGRESS.
Fatos principais
- Arquivado
- 6 de mai. de 2026, 20:04
- Evento
- Data PDUFA definida
- Direção
- Positivo
- Empresa
MIRMMirum- Ativo
- zilurgisertib
- Fonte
- SEC 8-K
- Confiança
- Com fonte
- Calendário
- Decisão da FDA (PDUFA) · 26 de set. de 2026
Trecho da fonte
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