---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-025227"
form_type: "8-K"
ticker: "IVVD"
cik: "0001832038"
company_name: "Invivyd, Inc."
filed_at: "2025-02-24T23:59:59+00:00"
generated_at: "2026-05-26T06:23:58.627676+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA declines Invivyd's request to expand PEMGARDA EUA to COVID-19 treatment; prophylaxis EUA unchanged

## Summary
- FDA declined expansion of PEMGARDA EUA for mild-to-moderate COVID-19 treatment in immunocompromised patients with no alternative options.
- FDA reasoning: immunobridging must show superior antiviral activity, not just equivalence, to prior mAbs like adintrevimab.
- Invivyd provided data showing comparable antiviral activity and predicted clinical efficacy above convalescent plasma.
- Existing PEMGARDA EUA for pre-exposure prophylaxis remains in effect; treatment opportunity not in prior financial guidance.

## SEC filing metadata
- accession: 0000950170-25-025227
- form_type: 8-K
- ticker: IVVD
- cik: 0001832038
- company_name: Invivyd, Inc.
- filed_at: 2025-02-24T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- 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/1832038/000095017025025227/0000950170-25-025227-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1832038/000095017025025227/ivvd-20250221.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-025227
- JSON: https://secwatch.observer/filing/0000950170-25-025227.json
- Plain text: https://secwatch.observer/filing/0000950170-25-025227.txt

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