New 8K -ivvd

Invivyd announced FDA clearance of its IND application for VYD2311, a vaccine-alternative antibody for COVID prevention. The company plans to launch two pivotal clinical trials by year-end 2025: DECLARATION, a Phase 3 trial evaluating VYD2311's safety and efficacy versus placebo with ~2,000 participants, and LIBERTY, examining safety against mRNA vaccines with ~300 participants. Top-line data is expected by mid-2026.
The DECLARATION trial will assess both single-dose and monthly intramuscular injections of VYD2311, aiming to demonstrate three-month protection with potential longer-term efficacy. The LIBERTY trial will compare VYD2311's safety profile against mRNA vaccines and explore combination possibilities. Commercial launch quantities of VYD2311 are already produced.
The company's REVOLUTION clinical program aims to provide a non-vaccine alternative for COVID protection, allowing individuals flexibility in choosing their protection regimen. The trials are funded through Invivyd's recent capital raise, with additional program details to be shared at an upcoming investor event.