---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-275646"
form_type: "8-K"
ticker: "DBVT"
cik: "0001613780"
company_name: "DBV Technologies S.A."
filed_at: "2024-12-11T23:59:59+00:00"
generated_at: "2026-05-29T04:43:13.496967+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# DBV gains FDA alignment on Accelerated Approval pathway for Viaskin Peanut patch in toddlers 1-3 years

## Summary
- FDA confirmed Phase 3 EPITOPE efficacy data serves as intermediate endpoint for Accelerated Approval.
- COMFORT Toddlers safety study on-track for 2Q 2025 start; will enroll ~480 subjects at 80-90 centers.
- Post-marketing confirmatory study criteria agreed; BLA submission for toddlers anticipated 2H 2026.
- Commercial Viaskin Peanut patch (used in 304 subjects OLE) deemed different product; no safety/efficacy differences vs clinical patch.
- Adhesion will be exploratory endpoint in COMFORT Toddlers, not co-objective; wear time data methodology aligned with FDA.

## SEC filing metadata
- accession: 0001193125-24-275646
- form_type: 8-K
- ticker: DBVT
- cik: 0001613780
- company_name: DBV Technologies S.A.
- filed_at: 2024-12-11T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1613780/000119312524275646/0001193125-24-275646-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1613780/000119312524275646/d857224d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-275646
- JSON: https://secwatch.observer/filing/0001193125-24-275646.json
- Plain text: https://secwatch.observer/filing/0001193125-24-275646.txt

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