{"schema_version":"secwatch.filing_event.v1","accession":"0001683168-25-004117","form_type":"8-K","ticker":"ACTU","cik":"0001652935","company_name":"ACTUATE THERAPEUTICS, INC.","filed_at":"2025-06-02T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.213341+00:00","generated_at":"2026-05-20T02:58:45.456563+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Actuate reports Phase 2 elraglusib/GnP meets primary OS endpoint in mPDAC","bullets":["mOS 10.1 months vs 7.2 months for GnP alone, HR=0.63, log-rank p=0.01, 37% risk reduction.","12-month OS rate 44.1% vs 22.3% (p=0.0005); 24-month OS rate 13.8% vs 0%.","ORR 29.0% vs 21.8%; DCR 61.3% vs 56.4%; mPFS 5.6 vs 5.1 months (HR=0.90, not significant).","Safety profile similar between arms; transient, reversible visual impairments most common TRAEs.","Company plans to request pre-NDA meeting with FDA in 2H 2025 for registration path."],"urls":{"canonical":"https://secwatch.observer/filing/0001683168-25-004117","json":"https://secwatch.observer/filing/0001683168-25-004117.json","markdown":"https://secwatch.observer/filing/0001683168-25-004117.md","text":"https://secwatch.observer/filing/0001683168-25-004117.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1652935/000168316825004117/0001683168-25-004117-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1652935/000168316825004117/actuate_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-20T02:58:45.456563+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"}