secwatch.observer — SEC 8-K summary
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Issuer:     Aptose Biosciences Inc. (APTOF)
CIK:        0000882361
Form:       8-K
Filed at:   2025-02-20T23:59:59+00:00
Accession:  0001171843-25-000957
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Aptose gets CSRC approval to escalate TUS dose; CRs seen in difficult AML
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- CSRC unanimously approves dose escalation from 40 mg to 80 mg of tuspetinib in TUSCANY trial of TUS+VEN+AZA triplet.
- Four patients dosed at 40 mg; no DLTs or prolonged myelosuppression; all remain on study.
- Two FLT3-WT patients achieved CR/CRh; one patient with biallelic TP53 mutations and complex karyotype achieved CR.
- Enrollment open for 80 mg cohort; 18-24 patients expected by mid-late 2025.
- PK shows TUS plasma levels unaffected by AZA; VEN levels consistent with prior studies.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/882361/000117184325000957/0001171843-25-000957-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/882361/000117184325000957/f8k_022025.htm
  HTML page:      https://secwatch.observer/filing/0001171843-25-000957

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