secwatch.observer — SEC 8-K summary
======================================

Issuer:     DBV Technologies S.A. (DBVT)
CIK:        0001613780
Form:       8-K
Filed at:   2023-03-07T23:59:59+00:00
Accession:  0001193125-23-063077
Event type: other_material
Sentiment:  neutral
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

DBV screens first patient in VITESSE Phase 3 peanut allergy trial for ages 4–7
------------------------------------------------------------------------------

- First patient screened at Midwest Allergy Sinus Asthma in Normal, Illinois for VITESSE Phase 3 trial.
- Trial enrolls 600 children ages 4–7, randomized 2:1 active (Viaskin Peanut 250 µg) vs placebo.
- Primary efficacy endpoint is treatment response rate at Month 12; last patient screening expected 1H 2024.
- Topline results anticipated in 1H 2025; FDA supports study to potentially support BLA submission.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1613780/000119312523063077/0001193125-23-063077-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1613780/000119312523063077/d471482d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-063077

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer