{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-123334","form_type":"8-K","ticker":"ACHV","cik":"0000949858","company_name":"ACHIEVE LIFE SCIENCES, INC.","filed_at":"2024-11-07T23:59:59+00:00","discovered_at":"2026-05-14T18:03:11.467616+00:00","generated_at":"2026-05-30T04:13:41.389827+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Achieve Life Sciences Q3 net loss $12.5M; ORCA-OL enrollment complete, NDA on track for Q2 2025","bullets":["Cash, equivalents and investments $42.9M as of Sep 30, 2024; operating expenses $12.5M for Q3.","Completed enrollment in Phase 3 ORCA-OL trial with 479 participants across 29 U.S. sites.","FDA granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette (vaping) cessation.","Leadership: Richard Stewart named CEO, Thomas King Executive Chairman, Jaime Xinos Chief Commercial Officer.","Planned NDA submission in Q2 2025; Data Safety Monitoring Committee found no safety concerns."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-123334","json":"https://secwatch.observer/filing/0000950170-24-123334.json","markdown":"https://secwatch.observer/filing/0000950170-24-123334.md","text":"https://secwatch.observer/filing/0000950170-24-123334.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/949858/000095017024123334/0000950170-24-123334-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/949858/000095017024123334/achv-20241107.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T04:13:41.389827+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"}