{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-146994","form_type":"8-K","ticker":"DBVT","cik":"0001613780","company_name":"DBV Technologies S.A.","filed_at":"2025-06-25T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.023931+00:00","generated_at":"2026-05-18T19:23:05.866368+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.5,"calibrated_materiality_score":0.5,"confidence":"high","headline":"DBV Technologies screens first subject in Phase 3 COMFORT Toddlers study for Viaskin Peanut","bullets":["First subject screened at Respiratory Medicine Research Institute of Michigan with Dr. Jeffrey Leflein as PI.","Study to enroll ~480 subjects at 80-90 centers across U.S., Canada, Australia, UK, and Europe.","BLA submission to FDA anticipated in 2H 2026 under Accelerated Approval Pathway.","Study supplements safety data from Phase 3 EPITOPE; 6-month DBPC phase + optional 18-month open-label."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-146994","json":"https://secwatch.observer/filing/0001193125-25-146994.json","markdown":"https://secwatch.observer/filing/0001193125-25-146994.md","text":"https://secwatch.observer/filing/0001193125-25-146994.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1613780/000119312525146994/0001193125-25-146994-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1613780/000119312525146994/d51953d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T19:23:05.866368+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"}