{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-275646","form_type":"8-K","ticker":"DBVT","cik":"0001613780","company_name":"DBV Technologies S.A.","filed_at":"2024-12-11T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.985291+00:00","generated_at":"2026-05-29T04:43:13.496967+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"DBV gains FDA alignment on Accelerated Approval pathway for Viaskin Peanut patch in toddlers 1-3 years","bullets":["FDA confirmed Phase 3 EPITOPE efficacy data serves as intermediate endpoint for Accelerated Approval.","COMFORT Toddlers safety study on-track for 2Q 2025 start; will enroll ~480 subjects at 80-90 centers.","Post-marketing confirmatory study criteria agreed; BLA submission for toddlers anticipated 2H 2026.","Commercial Viaskin Peanut patch (used in 304 subjects OLE) deemed different product; no safety/efficacy differences vs clinical patch.","Adhesion will be exploratory endpoint in COMFORT Toddlers, not co-objective; wear time data methodology aligned with FDA."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-275646","json":"https://secwatch.observer/filing/0001193125-24-275646.json","markdown":"https://secwatch.observer/filing/0001193125-24-275646.md","text":"https://secwatch.observer/filing/0001193125-24-275646.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1613780/000119312524275646/0001193125-24-275646-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1613780/000119312524275646/d857224d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T04:43:13.496967+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"}