Invivyd: la FDA aprueba la IND para VYD2311; ensayos pivotales comienzan a finales de 2025, datos principales a mediados de 2026

La FDA aprobó la IND y se alineó con el programa pivotal REVOLUTION para VYD2311. Dos ensayos de fase 3 (DECLARATION 1.770 pacientes; LIBERTY 210 pacientes) están programados para comenzar alrededor de finales de 2025, con datos principales esperados a mediados de 2026.

Datos clave

Presentado: 6 nov 2025, 12:10
Evento: Cambio en el registro de ensayos
Dirección: Positivo
Empresa: IVVDInvivyd
Activo: VYD2311
Fuente: SEC 8-K
Confianza: Con fuente

Extracto de la fuente

EX-99.1 2 d81968dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Invivyd Reports Third Quarter 2025 Financial Results and Recent Business Highlights • PEMGARDA ® (pemivibart) net product revenue of $13.1 million reported for Q3 2025, representing 41% growth year-over-year and 11% growth quarter-over-quarter • October 2025 ending cash and cash equivalents of over $100 million; ended Q3 2025 with $85.0 million in cash and cash equivalents after closing of $57.5 million public offering in August 2025, with additional $29.8 million gross proceeds from usage of at-the-market (ATM) offering facility in October 2025 • Announced U.S. IND clearance and alignment with U.S. FDA on pivotal clinical program for VYD2311, a vaccine-alternative antibody to prevent COVID • REVOLUTION, Invivyd’s developme

SEC 8-K