secwatch.observer — SEC 8-K summary
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Issuer:     Syndax Pharmaceuticals Inc (SNDX)
CIK:        0001395937
Form:       8-K
Filed at:   2024-11-12T23:59:59+00:00
Accession:  0000950170-24-124545
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Syndax reports positive pivotal Phase 2 results for revumenib in R/R mNPM1 AML; CR/CRh 23%
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- Primary endpoint met: CR/CRh rate 23% (15/64; 95% CI 14%–36%; p=0.0014) in efficacy-evaluable adult patients.
- ORR 47% (30/64); 75% had prior venetoclax; 36% received ≥3 prior lines of therapy.
- Safety profile consistent; 5% discontinued due to TRAEs. Grade ≥3 TRAEs: QTc prolongation 21%, anemia 14%, febrile neutropenia 13%, DS 13%, platelet count decreased 11%.
- sNDA filing for R/R mNPM1 AML expected in 1H25; FDA decision on KMT2Ar acute leukemias expected in 4Q24.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1395937/000095017024124545/0000950170-24-124545-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1395937/000095017024124545/sndx-20241112.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-124545

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