{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-060850","form_type":"8-K","ticker":"DBVT","cik":"0001613780","company_name":"DBV Technologies S.A.","filed_at":"2025-03-24T23:59:59+00:00","discovered_at":"2026-05-14T18:03:04.193190+00:00","generated_at":"2026-05-24T06:34:21.199279+00:00","sec_items":["2.02","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"DBVT: FDA agrees on safety data for Viaskin BLA in 4-7 yr olds; cash only into Apr 2025","bullets":["FDA aligns: safety data from VITESSE Phase 3 and OLE sufficient for BLA; no COMFORT Children study needed; BLA filing 1H 2026, potential launch acceleration ~1 year.","VITESSE Phase 3 topline results on track for Q4 2025; 654 participants enrolled, largest peanut allergy trial in 4-7 age group.","Cash $32.5M at Dec 31, 2024 (vs $141.4M); net loss $113.9M ($1.17 diluted EPS); operating expenses $120.7M.","Going concern: cash expected only into April 2025; company actively seeking additional capital and reviewing financing options."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-060850","json":"https://secwatch.observer/filing/0001193125-25-060850.json","markdown":"https://secwatch.observer/filing/0001193125-25-060850.md","text":"https://secwatch.observer/filing/0001193125-25-060850.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1613780/000119312525060850/0001193125-25-060850-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1613780/000119312525060850/d932759d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-24T06:34:21.199279+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"}