{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-069392","form_type":"8-K","ticker":"ACHV","cik":"0000949858","company_name":"ACHIEVE LIFE SCIENCES, INC.","filed_at":"2023-12-11T23:59:59+00:00","discovered_at":"2026-05-14T18:03:32.487319+00:00","generated_at":"2026-06-07T15:22:17.662927+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Achieve Life Sciences: FDA requires long-term safety data; NDA filing likely delayed","bullets":["FDA supports NDA on two Phase 3 trials but demands long-term safety data beyond 12 weeks for chronic-use label.","Company expects further FDA input in Q1 2024; NDA submission timing may be delayed.","Long-term safety data may be collected from cumulative treatment and vaping cessation program.","Single drug candidate cytisinicline at risk; delay could impact regulatory timeline."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-069392","json":"https://secwatch.observer/filing/0000950170-23-069392.json","markdown":"https://secwatch.observer/filing/0000950170-23-069392.md","text":"https://secwatch.observer/filing/0000950170-23-069392.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/949858/000095017023069392/0000950170-23-069392-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/949858/000095017023069392/achv-20231211.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T15:22:17.662927+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"}