---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-329488"
form_type: "8-K"
ticker: "IVVD"
cik: "0001832038"
company_name: "Invivyd, Inc."
filed_at: "2025-12-23T23:59:59+00:00"
generated_at: "2026-05-16T12:17:28.138088+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Invivyd receives FDA Fast Track designation for COVID antibody VYD2311

## Summary
- FDA Fast Track granted for VYD2311 to prevent COVID in individuals with risk factors for severe disease.
- VYD2311 is an investigational vaccine-alternative monoclonal antibody candidate.
- Phase 3 DECLARATION trial ongoing; top-line data expected mid-2026.
- Fast Track enables priority review and rolling BLA submission if criteria met.
- Total enrollment of 1770 participants in the placebo-controlled trial.

## SEC filing metadata
- accession: 0001193125-25-329488
- form_type: 8-K
- ticker: IVVD
- cik: 0001832038
- company_name: Invivyd, Inc.
- filed_at: 2025-12-23T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1832038/000119312525329488/0001193125-25-329488-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1832038/000119312525329488/ivvd-20251223.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-329488
- JSON: https://secwatch.observer/filing/0001193125-25-329488.json
- Plain text: https://secwatch.observer/filing/0001193125-25-329488.txt

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