---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-320901"
form_type: "8-K"
ticker: "DBVT"
cik: "0001613780"
company_name: "DBV Technologies S.A."
filed_at: "2025-12-16T23:59:59+00:00"
generated_at: "2026-05-16T13:03:42.039660+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.95
calibrated_materiality_score: 0.95
confidence: "high"
source: SEC EDGAR
---

# DBV Technologies reports positive Phase 3 VITESSE results; BLA submission on track for H1 2026

## Summary
- VITESSE met primary endpoint: response rate 46.6% vs 14.8% placebo (p<0.001); lower bound CI 24.5% >15% threshold.
- Safety consistent with prior studies: low discontinuations (3.2% active vs 0.5% placebo), no treatment-related SAEs.
- BLA submission for 4-7 year olds planned for first half 2026; prior FDA Breakthrough Therapy Designation.
- Positive results trigger acceleration of ABSA and BS warrants exercise period through Jan 15, 2026.
- 654 children enrolled, largest food allergy immunotherapy trial; compliance 96.2%.

## SEC filing metadata
- accession: 0001193125-25-320901
- form_type: 8-K
- ticker: DBVT
- cik: 0001613780
- company_name: DBV Technologies S.A.
- filed_at: 2025-12-16T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.95
- calibrated_materiality_score: 0.95
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1613780/000119312525320901/0001193125-25-320901-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1613780/000119312525320901/d28682d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-320901
- JSON: https://secwatch.observer/filing/0001193125-25-320901.json
- Plain text: https://secwatch.observer/filing/0001193125-25-320901.txt

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