secwatch.observer — SEC 8-K summary
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Issuer:     DBV Technologies S.A. (DBVT)
CIK:        0001613780
Form:       8-K
Filed at:   2024-09-23T23:59:59+00:00
Accession:  0001193125-24-223743
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

DBV completes VITESSE Phase 3 screening early; topline data expected Q4 2025
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- Screening closed in August 2024, ahead of schedule; enrollment exceeded original goal.
- VITESSE enrolled >600 peanut-allergic children ages 4-7 across 86 sites in U.S., Canada, Europe, UK, Australia.
- Subjects randomized 2:1 to active Viaskin Peanut Patch vs placebo; 12-month study.
- Largest immunotherapy trial in peanut allergy; DBV targets Biologic License Application submission after data.
- Topline efficacy and safety results from VITESSE expected by Q4 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1613780/000119312524223743/0001193125-24-223743-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1613780/000119312524223743/d837908d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-223743

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