---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-075582"
form_type: "8-K"
ticker: "IVVD"
cik: "0001832038"
company_name: "Invivyd, Inc."
filed_at: "2024-03-25T23:59:59+00:00"
generated_at: "2026-06-04T08:41:40.135650+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Invivyd gets FDA EUA for PEMGARDA as COVID-19 PrEP for immunocompromised; cash $200.6M

## Summary
- FDA issued EUA for PEMGARDA (pemivibart) for pre-exposure prophylaxis of COVID-19 in adults/adolescents (≥12 yrs, ≥40 kg) with moderate-to-severe immune compromise.
- Estimated cash and cash equivalents of $200.6M as of Dec 31, 2023 (preliminary, unaudited).
- In Feb 2024, raised $40.5M gross proceeds from ATM share sales, strengthening balance sheet ahead of launch.
- Immunobridging established: Day 28 calculated sVNA titer vs JN.1 was 7365 (90% CI: 7148–7589); ratio to reference 0.82 (0.80–0.85).
- Anaphylaxis observed in 0.6% (4/623) of CANOPY participants; boxed warning and two-hour post-infusion monitoring required.

## SEC filing metadata
- accession: 0001193125-24-075582
- form_type: 8-K
- ticker: IVVD
- cik: 0001832038
- company_name: Invivyd, Inc.
- filed_at: 2024-03-25T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1832038/000119312524075582/0001193125-24-075582-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1832038/000119312524075582/d801617d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-075582
- JSON: https://secwatch.observer/filing/0001193125-24-075582.json
- Plain text: https://secwatch.observer/filing/0001193125-24-075582.txt

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