Registro de fuente primaria
MaterialSolicitud presentada
Viatris presenta la NDA para el parche semanal de estrógeno de baja dosis
Viatris presentó la NDA para su parche semanal de estrógeno de baja dosis ante la FDA a finales del tercer trimestre de 2025. La empresa prevé la aprobación para mediados de 2026. Esto hace avanzar el activo desde el desarrollo hasta la revisión regulatoria.
Datos clave
- Presentado
- 6 nov 2025, 12:53
- Evento
- Solicitud presentada
- Dirección
- Neutral
- Empresa
VTRSViatris- Activo
- low-dose estrogen
- Fuente
- SEC 8-K
- Confianza
- Con fuente
Extracto de la fuente
EX-99.1 2 exhibit991-3q25earningsrel.htm EX-99.1 Document Viatris Reports Third Quarter 2025 Results and Updates 2025 Financial Guidance • Delivers Total Revenues in Line With Expectations, Reflecting Strong Execution of its Global Business • Makes Late-Stage Pipeline Progress Including NDA Submission for Low-Dose Estrogen Weekly Patch • Acquires Aculys Pharma Including Rights to Pitolisant in Japan and Spydia® in Japan and Certain Other Markets in the Asia-Pacific Region • Returns More Than $920 Million of Capital to Shareholders Year-to-Date, Including $500 Million in Share Repurchases • Raises and Narrows 2025 Financial Guidance Ranges for Total Revenues, Adjusted EBITDA and Adjusted EPS [1] PITTSBURGH – November 6, 2025 – Viatris Inc. (Nasdaq: VTRS) today reported strong third