{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-023533","form_type":"8-K","ticker":"ACHV","cik":"0000949858","company_name":"ACHIEVE LIFE SCIENCES, INC.","filed_at":"2023-05-23T23:59:59+00:00","discovered_at":"2026-05-14T18:03:42.971585+00:00","generated_at":"2026-06-14T17:47:16.268461+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Achieve Life Sciences reports positive Phase 3 ORCA-3 data; 12-week cytisinicline 30.3% quit rate vs 9.4% placebo","bullets":["12-week cytisinicline: 30.3% quit rate last 4 wks, 4.4x odds vs placebo (p<0.0001); continuous abstinence wk9-24: 20.5% vs 4.2%","6-week cytisinicline: 14.8% quit rate last 4 wks, 2.85x odds vs placebo (p=0.0008); continuous abstinence wk3-24: 6.8% vs 1.1%","No treatment-related serious adverse events; common side effects: insomnia (11.9% 12-wk), abnormal dreams, nausea, headache","ORCA-3 enrolled 792 adult smokers at 20 US sites; results consistent with prior Phase 3 ORCA-2 study","Cytisinicline could be first new prescription smoking cessation treatment in ~20 years; conference call May 23 at 8:30AM EDT"],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-023533","json":"https://secwatch.observer/filing/0000950170-23-023533.json","markdown":"https://secwatch.observer/filing/0000950170-23-023533.md","text":"https://secwatch.observer/filing/0000950170-23-023533.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/949858/000095017023023533/0000950170-23-023533-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/949858/000095017023023533/achv-20230523.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-14T17:47:16.268461+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"}