Registro de fuente primaria
Invivyd anunció que los datos principales del ensayo clínico pivotal DECLARATION de fase 3 para VYD2311 se esperan para mediados de 2026. El ensayo está evaluando VYD2311 para la prevención de COVID-19. Se ha logrado la inscripción completa y el Comité Independiente de Monitoreo de Datos ha recomendado permitir la inscripción de mujeres embarazadas y en período de lactancia.
EX-99.1 2 d118119dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Invivyd Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Recent Business Highlights and DECLARATION Clinical Trial Updates • Achieved Q4 2025 PEMGARDA ® (pemivibart) net product revenue of $17.2 million, representing 25% growth year-over-year and 31% growth quarter-over-quarter • 2025 year-end cash and cash equivalents of $226.7 million after raising over $200 million from financing transactions in 2H 2025 • Announced initiation of DECLARATION Phase 3 pivotal clinical trial of vaccine-alternative antibody VYD2311 to prevent COVID, with top-line data expected mid-2026; Fast Track designation for VYD2311 granted by FDA in December 2025 • DECLARATION trial on track with full enrollment achieved • DEC