{"schema_version":"secwatch.filing_event.v1","accession":"0001683168-25-003163","form_type":"8-K","ticker":"ACTU","cik":"0001652935","company_name":"ACTUATE THERAPEUTICS, INC.","filed_at":"2025-05-06T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.212880+00:00","generated_at":"2026-05-22T12:30:14.541683+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Actuate elraglusib Phase 2 meets primary endpoint with statistically significant OS improvement in mPDAC","bullets":["Elraglusib plus GnP showed statistically significant overall survival improvement vs GnP alone in first-line mPDAC.","Median overall survival substantially improved from December 2024 analysis; 1-year survival rate also significantly increased.","Trial achieved primary endpoint; favorable risk-benefit profile; data to be presented at ASCO on May 31, 2025.","Company plans to meet with US and EU regulators in H2 2025 to advance toward NDA and registration.","This is the first major advance in first-line mPDAC survival in over a decade, per management."],"urls":{"canonical":"https://secwatch.observer/filing/0001683168-25-003163","json":"https://secwatch.observer/filing/0001683168-25-003163.json","markdown":"https://secwatch.observer/filing/0001683168-25-003163.md","text":"https://secwatch.observer/filing/0001683168-25-003163.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1652935/000168316825003163/0001683168-25-003163-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1652935/000168316825003163/actuate_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-22T12:30:14.541683+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"}