{"schema_version":"secwatch.filing_event.v1","accession":"0001398733-26-000044","form_type":"8-K","ticker":"AQST","cik":"0001398733","company_name":"Aquestive Therapeutics, Inc.","filed_at":"2026-09-17T11:02:30+00:00","discovered_at":"2026-09-17T11:05:00.822870+00:00","generated_at":"2026-09-17T11:05:07.466642+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Aquestive resubmits Anaphylm NDA to FDA; addresses CRL with positive human factor/PK data","bullets":["Resubmitted NDA for Anaphylm (dibutepinephrine) sublingual film to FDA on Sept 17, 2026, for Type I allergic reactions including anaphylaxis.","Human factors study with revised packaging cut median pouch-opening time from 17s to 3s; no protocol-defined use errors in self-administration arm of confirmatory PK study.","Original NDA filed March 2025; FDA CRL issued Jan 30, 2026, requested human factors and confirmatory PK studies.","FDA will determine resubmission classification and set review timeline after initial review of the resubmission."],"urls":{"canonical":"https://secwatch.observer/filing/0001398733-26-000044","json":"https://secwatch.observer/filing/0001398733-26-000044.json","markdown":"https://secwatch.observer/filing/0001398733-26-000044.md","text":"https://secwatch.observer/filing/0001398733-26-000044.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1398733/000139873326000044/0001398733-26-000044-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1398733/000139873326000044/aqst-20260914.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-17T11:05:07.466642+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"}