{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-268056","form_type":"8-K","ticker":"ACHV","cik":"0000949858","company_name":"ACHIEVE LIFE SCIENCES, INC.","filed_at":"2025-11-06T23:59:59+00:00","discovered_at":"2026-05-14T18:02:42.701143+00:00","generated_at":"2026-05-17T00:08:30.431442+00:00","sec_items":["2.02","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"ACHV Q3 net loss $14.4M; FDA accepts cytisinicline NDA, PDUFA June 20, 2026","bullets":["Net loss $14.4M for Q3 2025; cash, equivalents & marketable securities $48.1M at Sep 30.","FDA accepted cytisinicline NDA for smoking cessation; PDUFA target action date June 20, 2026.","FDA awarded Commissioner’s National Priority Voucher for vaping cessation, enabling 1-2 month expedited review.","Appointed Erik Atkisson as Chief Legal Officer; over 25 years biopharma legal experience.","New post hoc data in Thorax shows cytisinicline improved quit rates in adults with COPD."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-268056","json":"https://secwatch.observer/filing/0001193125-25-268056.json","markdown":"https://secwatch.observer/filing/0001193125-25-268056.md","text":"https://secwatch.observer/filing/0001193125-25-268056.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/949858/000119312525268056/0001193125-25-268056-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/949858/000119312525268056/achv-20251106.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T00:08:30.431442+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"}