{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-24-041432","form_type":"8-K","ticker":"AQST","cik":"0001398733","company_name":"Aquestive Therapeutics, Inc.","filed_at":"2024-09-27T23:59:59+00:00","discovered_at":"2026-05-14T18:03:12.910775+00:00","generated_at":"2026-05-31T01:06:19.230524+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Aquestive completes Anaphylm oral allergen challenge enrollment; unveils AQST-108 Phase 2 for alopecia areata","bullets":["Anaphylm (epinephrine sublingual film) oral allergen challenge study fully enrolled; topline data expected Q4 2024.","Pre-NDA meeting request submitted to FDA; NDA submission planned for Q1 2025, launch by end-2025 or early 2026.","AQST-108 (epinephrine topical gel) first human study completed: no serious adverse events, zero plasma drug levels observed.","AQST-108 to be developed for alopecia areata (6.7M US patients); Phase 2 design outlined for mild-to-moderate disease.","Pre-IND meeting for AQST-108 targeted Q1 2025; Phase 2 initiation expected H2 2025 pending FDA alignment."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-24-041432","json":"https://secwatch.observer/filing/0001628280-24-041432.json","markdown":"https://secwatch.observer/filing/0001628280-24-041432.md","text":"https://secwatch.observer/filing/0001628280-24-041432.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1398733/000162828024041432/0001628280-24-041432-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1398733/000162828024041432/aqst-20240927.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T01:06:19.230524+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"}