{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-046174","form_type":"8-K","ticker":"ATXI","cik":"0001644963","company_name":"AVENUE THERAPEUTICS, INC.","filed_at":"2023-04-17T23:59:59+00:00","discovered_at":"2026-05-14T18:03:39.813336+00:00","generated_at":"2026-06-17T01:23:39.914012+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Avenue Therapeutics announces FDA agreement on most protocol items for IV Tramadol safety study","bullets":["Received official meeting minutes from FDA Type C meeting on March 9, 2023, for IV Tramadol.","FDA and Avenue agree on majority of proposed protocol items for opioid-induced respiratory depression study vs IV morphine.","FDA agrees a successful study could support complete response to second Complete Response Letter for IV Tramadol.","Company expects to finalize protocol and potentially initiate Phase 3 safety study this year; also planning updates on AJ201 and BAER-101 programs."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-046174","json":"https://secwatch.observer/filing/0001104659-23-046174.json","markdown":"https://secwatch.observer/filing/0001104659-23-046174.md","text":"https://secwatch.observer/filing/0001104659-23-046174.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1644963/000110465923046174/0001104659-23-046174-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1644963/000110465923046174/tm2312933d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-17T01:23:39.914012+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"}