---
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"
generated_at: "2026-05-22T12:30:14.541683+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Actuate elraglusib Phase 2 meets primary endpoint with statistically significant OS improvement in mPDAC

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001683168-25-003163
- JSON: https://secwatch.observer/filing/0001683168-25-003163.json
- Plain text: https://secwatch.observer/filing/0001683168-25-003163.txt

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