secwatch.observer — SEC 8-K summary
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Issuer:     ACTUATE THERAPEUTICS, INC. (ACTU)
CIK:        0001652935
Form:       8-K
Filed at:   2025-05-06T23:59:59+00:00
Accession:  0001683168-25-003163
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1652935/000168316825003163/0001683168-25-003163-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1652935/000168316825003163/actuate_8k.htm
  HTML page:      https://secwatch.observer/filing/0001683168-25-003163

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer