secwatch.observer — SEC 8-K summary
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Issuer:     ACTUATE THERAPEUTICS, INC. (ACTU)
CIK:        0001652935
Form:       8-K
Filed at:   2025-06-02T23:59:59+00:00
Accession:  0001683168-25-004117
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Actuate reports Phase 2 elraglusib/GnP meets primary OS endpoint in mPDAC
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- mOS 10.1 months vs 7.2 months for GnP alone, HR=0.63, log-rank p=0.01, 37% risk reduction.
- 12-month OS rate 44.1% vs 22.3% (p=0.0005); 24-month OS rate 13.8% vs 0%.
- ORR 29.0% vs 21.8%; DCR 61.3% vs 56.4%; mPFS 5.6 vs 5.1 months (HR=0.90, not significant).
- Safety profile similar between arms; transient, reversible visual impairments most common TRAEs.
- Company plans to request pre-NDA meeting with FDA in 2H 2025 for registration path.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1652935/000168316825004117/0001683168-25-004117-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1652935/000168316825004117/actuate_8k.htm
  HTML page:      https://secwatch.observer/filing/0001683168-25-004117

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