---
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"
generated_at: "2026-05-30T01:59:30.134380+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Actuate Therapeutics receives FDA Rare Pediatric Disease Designation for elraglusib in Ewing sarcoma

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001683168-24-007857
- JSON: https://secwatch.observer/filing/0001683168-24-007857.json
- Plain text: https://secwatch.observer/filing/0001683168-24-007857.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.