---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-008995"
form_type: "8-K"
ticker: "IVVD"
cik: "0001832038"
company_name: "Invivyd, Inc."
filed_at: "2025-01-27T23:59:59+00:00"
generated_at: "2026-05-27T09:23:08.274000+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Invivyd submits XEC variant data to FDA supporting pemivibart treatment EUA amendment

## Summary
- Updated immunobridging analysis with XEC variant shows pemivibart titers substantially exceed adintrevimab in Days 0-5.
- Adintrevimab previously showed 66-74% risk reduction in hospitalization/death vs placebo in STAMP trial.
- No additional anaphylaxis reports during post-authorization use of PEMGARDA for COVID-19 PrEP to date.
- Submission consistent with prior analyses since July 2024; FDA review ongoing with no statutory deadline.

## SEC filing metadata
- accession: 0000950170-25-008995
- form_type: 8-K
- ticker: IVVD
- cik: 0001832038
- company_name: Invivyd, Inc.
- filed_at: 2025-01-27T23:59:59+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/1832038/000095017025008995/0000950170-25-008995-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1832038/000095017025008995/ivvd-20250127.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-008995
- JSON: https://secwatch.observer/filing/0000950170-25-008995.json
- Plain text: https://secwatch.observer/filing/0000950170-25-008995.txt

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