{"schema_version":"secwatch.filing_event.v1","accession":"0001683168-26-003684","form_type":"8-K","ticker":"ACTU","cik":"0001652935","company_name":"ACTUATE THERAPEUTICS, INC.","filed_at":"2026-05-11T21:27:24+00:00","discovered_at":"2026-05-11T21:30:00.357371+00:00","generated_at":"2026-05-11T21:37:24.103102+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Actuate Therapeutics receives FDA IND clearance for oral elraglusib Phase 1/2 study","bullets":["FDA cleared IND for Phase 1/2 study of oral elraglusib tablet in advanced solid tumors; initiation planned for 2H 2026.","Oral formulation aims to achieve higher exposure than IV; PK exposure correlated with improved OS in mPDAC Phase 2.","Elraglusib plus RAS inhibitor preclinical results expected mid-2026; combination potential in RAS-driven cancers.","Industry veteran Martin Huber, MD, appointed to Board; former President and CEO of Mersana Therapeutics."],"urls":{"canonical":"https://secwatch.observer/filing/0001683168-26-003684","json":"https://secwatch.observer/filing/0001683168-26-003684.json","markdown":"https://secwatch.observer/filing/0001683168-26-003684.md","text":"https://secwatch.observer/filing/0001683168-26-003684.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1652935/000168316826003684/0001683168-26-003684-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1652935/000168316826003684/actuate_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-11T21:37:24.103102+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"}