{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-25-034890","form_type":"8-K","ticker":"AQST","cik":"0001398733","company_name":"Aquestive Therapeutics, Inc.","filed_at":"2025-07-15T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.889535+00:00","generated_at":"2026-05-18T06:27:40.876087+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Aquestive obtains Health Canada meeting for Anaphylm NDS; EMA briefing book submitted","bullets":["Health Canada grants Q3 2025 meeting for planned New Drug Submission of Anaphylm (epinephrine) Sublingual Film.","Initial briefing book submitted to European Medicines Agency; MA submission planned as soon as possible.","U.S. NDA accepted with PDUFA target action date of January 31, 2026.","Company pursuing parallel ex-U.S. regulatory pathways for needle-free, device-free anaphylaxis treatment."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-25-034890","json":"https://secwatch.observer/filing/0001628280-25-034890.json","markdown":"https://secwatch.observer/filing/0001628280-25-034890.md","text":"https://secwatch.observer/filing/0001628280-25-034890.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1398733/000162828025034890/0001628280-25-034890-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1398733/000162828025034890/aqst-20250715.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T06:27:40.876087+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"}