secwatch.observer — SEC 8-K summary
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Issuer:     Syndax Pharmaceuticals Inc (SNDX)
CIK:        0001395937
Form:       8-K
Filed at:   2023-10-02T23:59:59+00:00
Accession:  0000950170-23-050922
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Syndax revumenib meets primary endpoint in pivotal AUGMENT-101 trial; CR/CRh 23% (p=0.0036)
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- Primary endpoint met with CR/CRh 23% (13/57) in pooled KMT2Ar acute leukemia; p=0.0036.
- 65% overall response rate in KMT2Ar AML; 50% of transplanted patients received post-transplant revumenib.
- Median duration of CR/CRh 6.4 months; 46% still in remission as of July 24, 2023.
- Favorable safety: only 6% discontinued due to TRAEs; no discontinuations for DS or QTc prolongation.
- Company to submit NDA for revumenib to FDA by year-end; funded into 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1395937/000095017023050922/0000950170-23-050922-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1395937/000095017023050922/sndx-20231002.htm
  HTML page:      https://secwatch.observer/filing/0000950170-23-050922

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