{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-241114","form_type":"8-K","ticker":"DBVT","cik":"0001613780","company_name":"DBV Technologies S.A.","filed_at":"2024-10-22T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.984570+00:00","generated_at":"2026-05-30T11:39:58.558665+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":"DBV gets FDA Accelerated Approval path for Viaskin Peanut patch in toddlers; cash $46.4M, going concern doubt","bullets":["FDA confirmed Accelerated Approval pathway for Viaskin Peanut patch in 1-3 year-olds; COMFORT safety study (n=300-350) to start Q2 2025.","VITESSE Phase 3 study in 4-7 year-olds enrolled 654 subjects; topline results expected Q4 2025.","EMA scientific advice confirms MAA path for 1-7 year-old indication in Europe using the modified patch.","Preliminary cash at Sep 30, 2024: $46.4M (down from $66.2M); Q3 net cash burn $19.8M.","Substantial doubt about going concern; cash expected to fund operations only into Q1 2025; additional capital needed."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-241114","json":"https://secwatch.observer/filing/0001193125-24-241114.json","markdown":"https://secwatch.observer/filing/0001193125-24-241114.md","text":"https://secwatch.observer/filing/0001193125-24-241114.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1613780/000119312524241114/0001193125-24-241114-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1613780/000119312524241114/d890731d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T11:39:58.558665+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"}