---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-408052"
form_type: "8-K"
ticker: "DBVT"
cik: "0001613780"
company_name: "DBV Technologies S.A."
filed_at: "2026-09-30T01:18:49+00:00"
generated_at: "2026-10-12T13:55:27.220990+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.68
calibrated_materiality_score: 0.68
confidence: "high"
source: SEC EDGAR
---

# DBV Technologies submits BLA to FDA for VIASKIN Peanut Patch in children aged 4-7, requests Priority Review

## Summary
- BLA submitted September 29, 2026 for the VIASKIN Peanut Patch (250 µg) in children aged 4 through 7 years with peanut allergy; DBV requested Priority Review.
- Application is supported by the Phase 3 VITESSE trial in 654 children, randomized 2:1, conducted at 86 sites across the US, Canada, UK, Europe and Australia.
- Primary endpoint: difference in responder rate between active and placebo groups after 12 months; patients could continue into an open-label extension for up to three years.
- FDA previously granted Breakthrough Therapy Designation to the VIASKIN Peanut Patch; CEO Daniel Tassé called the submission a milestone in DBV's transformation into a commercial organization.
- VIASKIN uses epicutaneous immunotherapy (EPIT), a non-oral, non-injection approach designed to progressively desensitize children to peanut allergy.

## SEC filing metadata
- accession: 0001193125-26-408052
- form_type: 8-K
- ticker: DBVT
- cik: 0001613780
- company_name: DBV Technologies S.A.
- filed_at: 2026-09-30T01:18:49+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.68
- calibrated_materiality_score: 0.68
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1613780/000119312526408052/0001193125-26-408052-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1613780/000119312526408052/d118963d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-408052
- JSON: https://secwatch.observer/filing/0001193125-26-408052.json
- Plain text: https://secwatch.observer/filing/0001193125-26-408052.txt

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