{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-25-031455","form_type":"8-K","ticker":"AQST","cik":"0001398733","company_name":"Aquestive Therapeutics, Inc.","filed_at":"2025-06-16T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.164770+00:00","generated_at":"2026-05-19T06:12:05.375145+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":"FDA accepts Aquestive's NDA for Anaphylm; PDUFA date Jan 31, 2026","bullets":["FDA accepted NDA for Anaphylm (epinephrine oral film) to treat Type 1 allergic reactions, including anaphylaxis.","PDUFA target action date assigned as January 31, 2026; FDA may hold an Advisory Committee meeting.","If approved, Anaphylm would be first and only orally delivered epinephrine option in the U.S.","Product is a thin, device-free film that requires no special storage, fitting in wallet or pocket."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-25-031455","json":"https://secwatch.observer/filing/0001628280-25-031455.json","markdown":"https://secwatch.observer/filing/0001628280-25-031455.md","text":"https://secwatch.observer/filing/0001628280-25-031455.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1398733/000162828025031455/0001628280-25-031455-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1398733/000162828025031455/aqst-20250613.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-19T06:12:05.375145+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"}