{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-106920","form_type":"8-K","ticker":"DBVT","cik":"0001613780","company_name":"DBV Technologies S.A.","filed_at":"2023-04-20T23:59:59+00:00","discovered_at":"2026-05-14T18:03:39.668702+00:00","generated_at":"2026-06-16T22:32:14.621440+00:00","sec_items":["2.02","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"DBV gets FDA path for Viaskin Peanut BLA in toddlers 1-3; EPITOPE efficacy confirmed","bullets":["FDA confirmed Phase 3 EPITOPE met primary endpoint; no additional efficacy study required.","FDA requires new safety study in ~600 toddlers to augment safety data; no food challenge needed.","Company to submit safety study protocol to FDA by end of Q2 2023; Human Factors study and CMC work ongoing.","Cash and cash equivalents $192.3M as of March 31, 2023 (down $16.9M from Dec 31, 2022).","Viaskin Peanut in 1-3 and 4-7 year-olds remain separate product candidates with independent paths."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-106920","json":"https://secwatch.observer/filing/0001193125-23-106920.json","markdown":"https://secwatch.observer/filing/0001193125-23-106920.md","text":"https://secwatch.observer/filing/0001193125-23-106920.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1613780/000119312523106920/0001193125-23-106920-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1613780/000119312523106920/d490619d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-16T22:32:14.621440+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"}