{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-24-043505","form_type":"8-K","ticker":"AQST","cik":"0001398733","company_name":"Aquestive Therapeutics, Inc.","filed_at":"2024-10-24T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.342180+00:00","generated_at":"2026-05-30T10:24:35.048639+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Aquestive positive OAS study: Anaphylm resolves symptoms in 12 min median, meets endpoints","bullets":["OAS challenge study met primary and secondary endpoints; no significant PK difference with vs. without allergen.","Median time to complete symptom resolution: 12 minutes (vs. 74 minutes at screening); symptoms began resolving as early as 2 min.","All instances of symptomatic swelling resolved within 5 minutes after Anaphylm administration.","Pre-NDA meeting with FDA requested in Q4 2024; NDA submission planned Q1 2025; potential launch Q1 2026 if approved.","Anaphylm is a non-invasive oral epinephrine film for severe allergic reactions; adverse events mild/moderate and resolved."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-24-043505","json":"https://secwatch.observer/filing/0001628280-24-043505.json","markdown":"https://secwatch.observer/filing/0001628280-24-043505.md","text":"https://secwatch.observer/filing/0001628280-24-043505.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1398733/000162828024043505/0001628280-24-043505-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1398733/000162828024043505/aqst-20241024.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T10:24:35.048639+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"}