Clinical Read2026-09-30

VYD2311 - (DECLARATION)

Invivyd Inc.IVVD
Indication
COVID-19
Stage
phase3
Event
Topline Data
Details

August 13, 2026: Invivyd, Inc. (NASDAQ: IVVD) reported Q2 2026 results and multiple catalyst updates across COVID-19, measles, and RSV programs. PEMGARDA (pemivibart) generated Q2 net product revenue of $14.3 million, up 21% from $11.8 million in Q2 2025. In July 2026, the company said it received 12 months’ advance notice of PEMGARDA’s EUA termination and is discussing next steps with FDA.

For VYD2311 (COVID-19 prophylaxis), the Phase 3 DECLARATION pivotal trial completed enrollment in June 2026 after a blinded sample size re-estimation announced in April; top-line data are planned later in Q3 2026 and the study is intended to support a potential BLA submission. The Phase 3 LIBERTY trial completed enrollment and first dosing in June 2026, is now fully dosed, and top-line safety/immunology data are expected in late Q3 2026. FDA also agreed to an initial pediatric study plan (DRUMMER) for children 0-11 years, to be pursued if DECLARATION succeeds. A Phase 2 study of VYD2311 in Long COVID or COVID vaccine injury was planned for mid-2026.

Other pipeline updates: VMS063 (measles mAb) began IND-enabling work with IND readiness targeted in 2H 2026; VBY329 (RSV prophylaxis) is also targeted for IND readiness in 2H 2026. Cash was $160.1 million at June 30, 2026, which the company said should fund operations through the DECLARATION readout and potential VYD2311 launch readiness.