---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-241114"
form_type: "8-K"
ticker: "DBVT"
cik: "0001613780"
company_name: "DBV Technologies S.A."
filed_at: "2024-10-22T23:59:59+00:00"
generated_at: "2026-05-30T11:39:58.558665+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# DBV gets FDA Accelerated Approval path for Viaskin Peanut patch in toddlers; cash $46.4M, going concern doubt

## Summary
- FDA confirmed Accelerated Approval pathway for Viaskin Peanut patch in 1-3 year-olds; COMFORT safety study (n=300-350) to start Q2 2025.
- VITESSE Phase 3 study in 4-7 year-olds enrolled 654 subjects; topline results expected Q4 2025.
- EMA scientific advice confirms MAA path for 1-7 year-old indication in Europe using the modified patch.
- Preliminary cash at Sep 30, 2024: $46.4M (down from $66.2M); Q3 net cash burn $19.8M.
- Substantial doubt about going concern; cash expected to fund operations only into Q1 2025; additional capital needed.

## SEC filing metadata
- accession: 0001193125-24-241114
- form_type: 8-K
- ticker: DBVT
- cik: 0001613780
- company_name: DBV Technologies S.A.
- filed_at: 2024-10-22T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 2.02, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1613780/000119312524241114/0001193125-24-241114-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1613780/000119312524241114/d890731d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-241114
- JSON: https://secwatch.observer/filing/0001193125-24-241114.json
- Plain text: https://secwatch.observer/filing/0001193125-24-241114.txt

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