Invivyd: FDA aprova IND para VYD2311; ensaios pivô iniciam no final de 2025, dados principais em meados de 2026

A FDA aprovou o IND e alinhou-se ao programa pivô REVOLUTION para VYD2311. Dois ensaios de Fase 3 (DECLARATION 1.770 pacientes; LIBERTY 210 pacientes) estão programados para começar por volta do final de 2025, com dados principais esperados para meados de 2026.

Fatos principais

Arquivado: 6 de nov. de 2025, 12:10
Evento: Alteração no registro do ensaio
Direção: Positivo
Empresa: IVVDInvivyd
Ativo: VYD2311
Fonte: SEC 8-K
Confiança: Com fonte

Trecho da fonte

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