---
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"
generated_at: "2026-05-11T21:37:24.103102+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 IND clearance for oral elraglusib Phase 1/2 study

## Summary
- 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.

## SEC filing metadata
- 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
- 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/1652935/000168316826003684/0001683168-26-003684-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1652935/000168316826003684/actuate_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001683168-26-003684
- JSON: https://secwatch.observer/filing/0001683168-26-003684.json
- Plain text: https://secwatch.observer/filing/0001683168-26-003684.txt

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