{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-069804","form_type":"8-K","ticker":"ACHV","cik":"0000949858","company_name":"ACHIEVE LIFE SCIENCES, INC.","filed_at":"2025-05-13T23:59:59+00:00","discovered_at":"2026-05-14T18:02:51.915433+00:00","generated_at":"2026-05-21T22:38:54.982142+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Q1 net loss $12.8M; on track for cytisinicline NDA submission to FDA in June 2025","bullets":["Cash, equivalents, and marketable securities totaled $23.2M; operating expenses $12.9M for Q1 2025.","Plans to submit NDA for cytisinicline to FDA in June 2025; ORCA-3 results published in JAMA Internal Medicine.","ORCA-OL long-term safety trial met FDA requirements: >300 patients with 6 months, >100 with 1 year treatment.","DSMC third safety review found no concerns; SAB meeting held in May 2025 with ten nicotine cessation experts."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-069804","json":"https://secwatch.observer/filing/0000950170-25-069804.json","markdown":"https://secwatch.observer/filing/0000950170-25-069804.md","text":"https://secwatch.observer/filing/0000950170-25-069804.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/949858/000095017025069804/0000950170-25-069804-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/949858/000095017025069804/achv-20250513.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-21T22:38:54.982142+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"}