secwatch.observer — SEC 8-K summary
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Issuer:     ACTUATE THERAPEUTICS, INC. (ACTU)
CIK:        0001652935
Form:       8-K
Filed at:   2026-05-11T21:27:24+00:00
Accession:  0001683168-26-003684
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Actuate Therapeutics receives FDA IND clearance for oral elraglusib Phase 1/2 study
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1652935/000168316826003684/0001683168-26-003684-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1652935/000168316826003684/actuate_8k.htm
  HTML page:      https://secwatch.observer/filing/0001683168-26-003684

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