{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-104569","form_type":"8-K","ticker":"ACHV","cik":"0000949858","company_name":"ACHIEVE LIFE SCIENCES, INC.","filed_at":"2025-08-07T23:59:59+00:00","discovered_at":"2026-05-14T18:02:46.757666+00:00","generated_at":"2026-05-17T18:47:11.834268+00:00","sec_items":["2.02","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Achieve Life Sciences submits cytisinicline NDA to FDA; cash position $55.4M","bullets":["NDA submitted to FDA in June 2025 for cytisinicline as smoking cessation treatment in adults.","Raised $49.3M gross from underwritten public offering in June-July 2025; expects runway into H2 2026.","Partnered with Omnicom for integrated launch strategy, reducing internal commercial buildout costs.","ORCA-OL safety requirements met: >300 subjects with ≥6 months, >100 with ≥1 year cumulative exposure.","Q2 2025 net loss $12.7M; operating expenses $12.6M; cash & securities $55.4M as of June 30."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-104569","json":"https://secwatch.observer/filing/0000950170-25-104569.json","markdown":"https://secwatch.observer/filing/0000950170-25-104569.md","text":"https://secwatch.observer/filing/0000950170-25-104569.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/949858/000095017025104569/0000950170-25-104569-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/949858/000095017025104569/achv-20250807.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T18:47:11.834268+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"}