{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-24-051956","form_type":"8-K","ticker":"AQST","cik":"0001398733","company_name":"Aquestive Therapeutics, Inc.","filed_at":"2024-12-19T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.343435+00:00","generated_at":"2026-05-29T01:22:32.899545+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA grants Aquestive 7-year orphan drug exclusivity for Libervant in pediatric seizure clusters ages 2-5","bullets":["FDA granted 7 years of orphan drug exclusivity to Libervant (diazepam) Buccal Film for treating seizure clusters in patients aged 2-5.","Exclusivity extends to April 2031; FDA cited buccal route as major contribution to patient care vs rectal route.","Libervant is the first and only FDA-approved orally administered rescue therapy for this pediatric population.","Originally designated as orphan drug in 2016; ODE now granted following approval on April 26, 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-24-051956","json":"https://secwatch.observer/filing/0001628280-24-051956.json","markdown":"https://secwatch.observer/filing/0001628280-24-051956.md","text":"https://secwatch.observer/filing/0001628280-24-051956.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1398733/000162828024051956/0001628280-24-051956-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1398733/000162828024051956/aqst-20241219.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T01:22:32.899545+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"}