---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-230898"
form_type: "8-K"
ticker: "IVVD"
cik: "0001832038"
company_name: "Invivyd, Inc."
filed_at: "2025-10-06T23:59:59+00:00"
generated_at: "2026-05-17T04:37:20.265678+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Invivyd announces FDA IND clearance for VYD2311; Phase 3 and Phase 2 trials to start year-end 2025

## Summary
- FDA cleared IND and aligned on pivotal clinical program for VYD2311, a vaccine-alternative monoclonal antibody to prevent COVID.
- DECLARATION Phase 3 trial (N=~2,000) will evaluate single and monthly IM doses vs placebo for 3-month prevention of symptomatic COVID.
- LIBERTY Phase 2 trial (N=~300) will compare safety/tolerability of VYD2311 vs mRNA vaccine and explore co-administration.
- Trials to begin year-end 2025 with top-line data anticipated mid-2026; funded by recent capital raise and commercial launch quantities ready.
- Details to be shared in public investor event later this month.

## SEC filing metadata
- accession: 0001193125-25-230898
- form_type: 8-K
- ticker: IVVD
- cik: 0001832038
- company_name: Invivyd, Inc.
- filed_at: 2025-10-06T23:59:59+00:00
- event_type: regulatory
- 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/1832038/000119312525230898/0001193125-25-230898-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1832038/000119312525230898/ivvd-20251006.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-230898
- JSON: https://secwatch.observer/filing/0001193125-25-230898.json
- Plain text: https://secwatch.observer/filing/0001193125-25-230898.txt

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