Arvinas: la FDA establece el 5 de junio de 2026 como fecha PDUFA para la NDA de vepdegestrant

La FDA ha aceptado la NDA de vepdegestrant y ha asignado una fecha de acción PDUFA del 5 de junio de 2026. Arvinas y Pfizer seleccionarán conjuntamente a un socio comercial externo para maximizar el potencial de lanzamiento si se aprueba.

Datos clave

Presentado: 5 nov 2025, 12:02
Evento: Fecha PDUFA fijada
Dirección: Positivo
Empresa: ARVNArvinas
Activo: vepdegestrant
Fuente: SEC 8-K
Confianza: Con fuente
Calendario: Decisión de la FDA (PDUFA) · 5 jun 2026 · Aprobado

Extracto de la fuente

EX-99.1 2 q32025earningsrelease.htm EX-99.1 Document Exhibit 99.1 Arvinas Reports Third Quarter 2025 Financial Results and Provides Corporate Update – Presented positive data from Phase 1 clinical trials with ARV-102 in healthy volunteers and patients with Parkinson’s disease – – Presented preclinical data from ARV-806 demonstrating robust and differentiated activity in models of KRAS G12D-mutated cancer – – Presented preclinical data from ARV-027 demonstrating robust degradation of polyQ-AR in muscle, supporting further evaluation as a potentially disease-modifying therapy in SBMA – – Announced agreement with Pfizer to jointly select a third party for the commercialization and potential further development of vepdegestrant – – Company to host conference call today at 8:00 a.m. ET –

SEC 8-K