Invivyd reports positive LIBERTY Phase 3 topline data for VYD2311 and plans FDA filing
Invivyd reported topline results from the Phase 3 LIBERTY study of its investigational COVID-19 antibody VYD2311, which it says showed a safety and tolerability profile superior to an mRNA COVID-19 vaccine. The company also plans to submit a Biologics License Application to the FDA under the Accelerated Approval pathway, pending data from the ongoing DECLARATION pivotal study expected in October 2026. For shareholders, the results come from a 210-person study, and the regulatory path depends on DECLARATION data that have not yet been reported.
Key points
- VYD2311 alone: 56.5% of subjects had a treatment-emergent adverse event, injection site reaction or hypersensitivity reaction over 6 days, versus 91.4% in the mRNA vaccine arm (P<0.0001).
- VYD2311 combined with the mRNA vaccine: 78.9% versus 91.4% on the same measure, with P=0.057 for that comparison.
- DECLARATION topline safety and immunogenicity data are expected in October 2026; that study enrolls approximately 2,400 participants.
- LIBERTY enrolled 210 healthy adults aged 18 to 49, randomized 1:1:1 across three arms.
The filing
Written by AI on Nov 9, 2026, 11:44 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 29, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.