{"schema_version":"secwatch.filing_event.v1","accession":"0001683168-24-007857","form_type":"8-K","ticker":"ACTU","cik":"0001652935","company_name":"ACTUATE THERAPEUTICS, INC.","filed_at":"2024-11-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.116292+00:00","generated_at":"2026-05-30T01:59:30.134380+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 Rare Pediatric Disease Designation for elraglusib in Ewing sarcoma","bullets":["FDA grants Rare Pediatric Disease Designation for elraglusib, a GSK-3β inhibitor, to treat Ewing sarcoma.","Designation makes elraglusib eligible for a Priority Review Voucher (PRV) upon future NDA approval; PRV can be sold.","Ongoing Phase 1/2 trial (NCT04239092) in relapsed/refractory EWS; topline Phase 1 data expected in 2H 2025.","Early data: two ongoing durable Complete Responses in first six patients; 8 patients enrolled to date.","Ewing sarcoma is the second most prevalent malignant tumor in children/adolescents; ~25% present with metastatic disease."],"urls":{"canonical":"https://secwatch.observer/filing/0001683168-24-007857","json":"https://secwatch.observer/filing/0001683168-24-007857.json","markdown":"https://secwatch.observer/filing/0001683168-24-007857.md","text":"https://secwatch.observer/filing/0001683168-24-007857.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1652935/000168316824007857/0001683168-24-007857-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1652935/000168316824007857/actuate_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T01:59:30.134380+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"}