secwatch.observer — SEC 8-K summary
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Issuer:     DBV Technologies S.A. (DBVT)
CIK:        0001613780
Form:       8-K
Filed at:   2026-09-30T01:18:49+00:00
Accession:  0001193125-26-408052
Event type: regulatory
Sentiment:  positive
Materiality: 0.68
Item codes: 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

DBV Technologies submits BLA to FDA for VIASKIN Peanut Patch in children aged 4-7, requests Priority Review
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- BLA submitted September 29, 2026 for the VIASKIN Peanut Patch (250 µg) in children aged 4 through 7 years with peanut allergy; DBV requested Priority Review.
- Application is supported by the Phase 3 VITESSE trial in 654 children, randomized 2:1, conducted at 86 sites across the US, Canada, UK, Europe and Australia.
- Primary endpoint: difference in responder rate between active and placebo groups after 12 months; patients could continue into an open-label extension for up to three years.
- FDA previously granted Breakthrough Therapy Designation to the VIASKIN Peanut Patch; CEO Daniel Tassé called the submission a milestone in DBV's transformation into a commercial organization.
- VIASKIN uses epicutaneous immunotherapy (EPIT), a non-oral, non-injection approach designed to progressively desensitize children to peanut allergy.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1613780/000119312526408052/0001193125-26-408052-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1613780/000119312526408052/d118963d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-408052

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