{"schema_version":"secwatch.filing_event.v1","accession":"0001398733-26-000005","form_type":"8-K","ticker":"AQST","cik":"0001398733","company_name":"Aquestive Therapeutics, Inc.","filed_at":"2026-02-02T23:59:59+00:00","discovered_at":"2026-05-14T18:02:34.987198+00:00","generated_at":"2026-05-16T05:34:55.116759+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Aquestive receives FDA CRL for Anaphylm; deficiencies limited to packaging, administration","bullets":["FDA CRL Jan 30, 2026 for Anaphylm NDA; deficiencies in human factors validation study and request for PK study.","Company plans Type A meeting, new HF and PK studies; expects resubmission in Q3 2026.","Global: positive EMA feedback no further trials needed; submit in Europe and Canada H2 2026; UK feedback Q1 2026.","CEO: issues limited to packaging/administration; company well-capitalized to complete approval and pre-launch."],"urls":{"canonical":"https://secwatch.observer/filing/0001398733-26-000005","json":"https://secwatch.observer/filing/0001398733-26-000005.json","markdown":"https://secwatch.observer/filing/0001398733-26-000005.md","text":"https://secwatch.observer/filing/0001398733-26-000005.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1398733/000139873326000005/0001398733-26-000005-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1398733/000139873326000005/aqst-20260130.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T05:34:55.116759+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"}