---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-406007"
form_type: "8-K"
ticker: "IVVD"
cik: "0001832038"
company_name: "Invivyd, Inc."
filed_at: "2026-09-29T11:26:46+00:00"
generated_at: "2026-10-12T13:41:51.501837+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Invivyd's VYD2311 bests COMIRNATY on safety in LIBERTY Phase 3; BLA via Accelerated Approval planned

## Summary
- LIBERTY randomized 210 healthy adults (18-49) 1:1:1 to 250mg VYD2311, COMIRNATY mRNA vaccine, or both; VYD2311 met all primary and secondary endpoints.
- 6-day TEAE/ISR/hypersensitivity: VYD2311 56.5% vs vaccine 91.4% (P<0.0001); 56-day rate 60.9% vs 91.4% (P<0.0001); combo arm 83.1% (P=0.21).
- Systemic AEs at 6 days: 44.1% for VYD2311 vs 68.1% for mRNA vaccine (P=0.008); combination 50.0% vs 68.1% (P=0.023).
- No VYD2311-related AE above Grade 2 and no hypersensitivity or anaphylaxis in any arm; co-administration raised vaccine neutralizing titers ~2.5x with no immunologic interference.
- After a September Type C meeting, Invivyd plans a BLA under Accelerated Approval; DECLARATION safety/immunogenicity topline data expected in October, efficacy unblinded post-approval.

## SEC filing metadata
- accession: 0001193125-26-406007
- form_type: 8-K
- ticker: IVVD
- cik: 0001832038
- company_name: Invivyd, Inc.
- filed_at: 2026-09-29T11:26:46+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1832038/000119312526406007/0001193125-26-406007-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1832038/000119312526406007/ivvd-20260929.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-406007
- JSON: https://secwatch.observer/filing/0001193125-26-406007.json
- Plain text: https://secwatch.observer/filing/0001193125-26-406007.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.