---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-180890"
form_type: "8-K"
ticker: "IVVD"
cik: "0001832038"
company_name: "Invivyd, Inc."
filed_at: "2025-08-14T23:59:59+00:00"
generated_at: "2026-05-17T13:25:01.752893+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Invivyd aligns with FDA on rapid BLA pathway for VYD2311; Q2 revenue $11.8M, up 413% YoY

## Summary
- Q2 2025 PEMGARDA net product revenue $11.8M, up 413% YoY; net loss $14.7M ($0.12/sh) vs $47.2M ($0.40/sh) in Q2 2024.
- Cash and cash equivalents $34.9M as of June 30, 2025; near-term profitability target not met but possible with upcoming season.
- FDA alignment on rapid BLA pathway for VYD2311; single Phase 2/3 trial with 12-week primary endpoint may support approval for COVID-19 prevention.
- Pipeline expansion: RSV candidate identification expected Q3 2025, measles candidate by end of 2025.
- VYD2311 safety data: 76-day half-life IM, attractive profile; quantities of commercial launch product available.

## SEC filing metadata
- accession: 0001193125-25-180890
- form_type: 8-K
- ticker: IVVD
- cik: 0001832038
- company_name: Invivyd, Inc.
- filed_at: 2025-08-14T23:59:59+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/1832038/000119312525180890/0001193125-25-180890-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1832038/000119312525180890/d936404d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-180890
- JSON: https://secwatch.observer/filing/0001193125-25-180890.json
- Plain text: https://secwatch.observer/filing/0001193125-25-180890.txt

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