---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-106920"
form_type: "8-K"
ticker: "DBVT"
cik: "0001613780"
company_name: "DBV Technologies S.A."
filed_at: "2023-04-20T23:59:59+00:00"
generated_at: "2026-06-16T22:32:14.621440+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# DBV gets FDA path for Viaskin Peanut BLA in toddlers 1-3; EPITOPE efficacy confirmed

## Summary
- FDA confirmed Phase 3 EPITOPE met primary endpoint; no additional efficacy study required.
- FDA requires new safety study in ~600 toddlers to augment safety data; no food challenge needed.
- Company to submit safety study protocol to FDA by end of Q2 2023; Human Factors study and CMC work ongoing.
- Cash and cash equivalents $192.3M as of March 31, 2023 (down $16.9M from Dec 31, 2022).
- Viaskin Peanut in 1-3 and 4-7 year-olds remain separate product candidates with independent paths.

## SEC filing metadata
- accession: 0001193125-23-106920
- form_type: 8-K
- ticker: DBVT
- cik: 0001613780
- company_name: DBV Technologies S.A.
- filed_at: 2023-04-20T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 2.02, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1613780/000119312523106920/0001193125-23-106920-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1613780/000119312523106920/d490619d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-106920
- JSON: https://secwatch.observer/filing/0001193125-23-106920.json
- Plain text: https://secwatch.observer/filing/0001193125-23-106920.txt

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