---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-146994"
form_type: "8-K"
ticker: "DBVT"
cik: "0001613780"
company_name: "DBV Technologies S.A."
filed_at: "2025-06-25T23:59:59+00:00"
generated_at: "2026-05-18T19:23:05.866368+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.5
calibrated_materiality_score: 0.5
confidence: "high"
source: SEC EDGAR
---

# DBV Technologies screens first subject in Phase 3 COMFORT Toddlers study for Viaskin Peanut

## Summary
- First subject screened at Respiratory Medicine Research Institute of Michigan with Dr. Jeffrey Leflein as PI.
- Study to enroll ~480 subjects at 80-90 centers across U.S., Canada, Australia, UK, and Europe.
- BLA submission to FDA anticipated in 2H 2026 under Accelerated Approval Pathway.
- Study supplements safety data from Phase 3 EPITOPE; 6-month DBPC phase + optional 18-month open-label.

## SEC filing metadata
- accession: 0001193125-25-146994
- form_type: 8-K
- ticker: DBVT
- cik: 0001613780
- company_name: DBV Technologies S.A.
- filed_at: 2025-06-25T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.5
- calibrated_materiality_score: 0.5
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1613780/000119312525146994/0001193125-25-146994-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1613780/000119312525146994/d51953d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-146994
- JSON: https://secwatch.observer/filing/0001193125-25-146994.json
- Plain text: https://secwatch.observer/filing/0001193125-25-146994.txt

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