{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-017068","form_type":"8-K","ticker":"ACHV","cik":"0000949858","company_name":"ACHIEVE LIFE SCIENCES, INC.","filed_at":"2025-02-10T23:59:59+00:00","discovered_at":"2026-05-14T18:03:06.915316+00:00","generated_at":"2026-05-27T00:46:24.447905+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Achieve DSMC finds no safety concerns in ORCA-OL; NDA on track for Q2 2025","bullets":["DSMC completed second independent review of ORCA-OL trial; no unexpected treatment-related adverse events identified.","Participants' adherence to cytisinicline was excellent; study continues as planned without modifications.","Achieve reiterates planned New Drug Application submission for cytisinicline in Q2 2025.","ORCA-OL enrolled 479 participants across 29 US sites; 300+ completed six months of cumulative cytisinicline treatment."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-017068","json":"https://secwatch.observer/filing/0000950170-25-017068.json","markdown":"https://secwatch.observer/filing/0000950170-25-017068.md","text":"https://secwatch.observer/filing/0000950170-25-017068.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/949858/000095017025017068/0000950170-25-017068-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/949858/000095017025017068/achv-20250210.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-27T00:46:24.447905+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"}