---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-295539"
form_type: "8-K"
ticker: "IVVD"
cik: "0001832038"
company_name: "Invivyd, Inc."
filed_at: "2026-07-06T11:11:45+00:00"
generated_at: "2026-07-06T11:15:06.250825+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Invivyd receives FDA notice of PEMGARDA EUA termination effective June 29, 2027; plans to pursue BLA approval

## Summary
- FDA sent Invivyd Notice of Termination for PEMGARDA EUA, effective June 29, 2027, following HHS termination of COVID-19 EUA declaration.
- PEMGARDA (pemivibart) authorized since March 2024 for COVID-19 pre-exposure prophylaxis in immunocompromised individuals.
- Invivyd intends to pursue Biologics License Application (BLA) for full FDA approval, citing clinical and post-authorization data.
- Company is in active dialogue with FDA on next steps; HHS has not provided specific written advice on approval pathway.
- Chairman Marc Elia states PEMGARDA has sufficient data for BLA submission and approval.

## SEC filing metadata
- accession: 0001193125-26-295539
- form_type: 8-K
- ticker: IVVD
- cik: 0001832038
- company_name: Invivyd, Inc.
- filed_at: 2026-07-06T11:11:45+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1832038/000119312526295539/0001193125-26-295539-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1832038/000119312526295539/ivvd-20260706.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-295539
- JSON: https://secwatch.observer/filing/0001193125-26-295539.json
- Plain text: https://secwatch.observer/filing/0001193125-26-295539.txt

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