secwatch.observer — SEC 8-K summary
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Issuer:     ACTUATE THERAPEUTICS, INC. (ACTU)
CIK:        0001652935
Form:       8-K
Filed at:   2024-11-12T23:59:59+00:00
Accession:  0001683168-24-007857
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 Rare Pediatric Disease Designation for elraglusib in Ewing sarcoma
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- FDA grants Rare Pediatric Disease Designation for elraglusib, a GSK-3β inhibitor, to treat Ewing sarcoma.
- Designation makes elraglusib eligible for a Priority Review Voucher (PRV) upon future NDA approval; PRV can be sold.
- Ongoing Phase 1/2 trial (NCT04239092) in relapsed/refractory EWS; topline Phase 1 data expected in 2H 2025.
- Early data: two ongoing durable Complete Responses in first six patients; 8 patients enrolled to date.
- Ewing sarcoma is the second most prevalent malignant tumor in children/adolescents; ~25% present with metastatic disease.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1652935/000168316824007857/0001683168-24-007857-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1652935/000168316824007857/actuate_8k.htm
  HTML page:      https://secwatch.observer/filing/0001683168-24-007857

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