---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-060850"
form_type: "8-K"
ticker: "DBVT"
cik: "0001613780"
company_name: "DBV Technologies S.A."
filed_at: "2025-03-24T23:59:59+00:00"
generated_at: "2026-05-24T06:34:21.199279+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# DBVT: FDA agrees on safety data for Viaskin BLA in 4-7 yr olds; cash only into Apr 2025

## Summary
- FDA aligns: safety data from VITESSE Phase 3 and OLE sufficient for BLA; no COMFORT Children study needed; BLA filing 1H 2026, potential launch acceleration ~1 year.
- VITESSE Phase 3 topline results on track for Q4 2025; 654 participants enrolled, largest peanut allergy trial in 4-7 age group.
- Cash $32.5M at Dec 31, 2024 (vs $141.4M); net loss $113.9M ($1.17 diluted EPS); operating expenses $120.7M.
- Going concern: cash expected only into April 2025; company actively seeking additional capital and reviewing financing options.

## SEC filing metadata
- accession: 0001193125-25-060850
- form_type: 8-K
- ticker: DBVT
- cik: 0001613780
- company_name: DBV Technologies S.A.
- filed_at: 2025-03-24T23:59:59+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/1613780/000119312525060850/0001193125-25-060850-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1613780/000119312525060850/d932759d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-060850
- JSON: https://secwatch.observer/filing/0001193125-25-060850.json
- Plain text: https://secwatch.observer/filing/0001193125-25-060850.txt

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