{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-408052","form_type":"8-K","ticker":"DBVT","cik":"0001613780","company_name":"DBV Technologies S.A.","filed_at":"2026-09-30T01:18:49+00:00","discovered_at":"2026-09-30T10:05:00.382430+00:00","generated_at":"2026-10-12T13:55:27.220990+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.68,"calibrated_materiality_score":0.68,"confidence":"high","headline":"DBV Technologies submits BLA to FDA for VIASKIN Peanut Patch in children aged 4-7, requests Priority Review","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-408052","json":"https://secwatch.observer/filing/0001193125-26-408052.json","markdown":"https://secwatch.observer/filing/0001193125-26-408052.md","text":"https://secwatch.observer/filing/0001193125-26-408052.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1613780/000119312526408052/0001193125-26-408052-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1613780/000119312526408052/d118963d8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T13:55:27.220990+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}