{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-24-049497","form_type":"8-K","ticker":"AQST","cik":"0001398733","company_name":"Aquestive Therapeutics, Inc.","filed_at":"2024-12-02T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.343234+00:00","generated_at":"2026-05-29T11:04:39.939632+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Aquestive receives positive FDA feedback for Anaphylm; reaffirms Q1 2025 NDA submission","bullets":["FDA agreed on NDA content, safety evaluation, and pediatric trial plan; no additional adult trials needed.","Single-dose pediatric trial commenced in U.S. and Canada in December 2024.","FDA noted an advisory committee meeting may be necessary due to new route of administration.","Reaffirms NDA submission guidance for Q1 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-24-049497","json":"https://secwatch.observer/filing/0001628280-24-049497.json","markdown":"https://secwatch.observer/filing/0001628280-24-049497.md","text":"https://secwatch.observer/filing/0001628280-24-049497.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1398733/000162828024049497/0001628280-24-049497-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1398733/000162828024049497/aqst-20241202.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T11:04:39.939632+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"}