secwatch.observer — SEC 8-K summary
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Issuer:     Syndax Pharmaceuticals Inc (SNDX)
CIK:        0001395937
Form:       8-K
Filed at:   2023-11-02T23:59:59+00:00
Accession:  0000950170-23-058156
Event type: earnings
Sentiment:  positive
Materiality: 0.80
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Syndax reports Q3 net loss $0.73/sh, initiates revumenib NDA in R/R KMT2Ar leukemia
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- Net loss $51.1M ($0.73/sh) vs $35.4M ($0.58/sh) YoY; cash $379.3M as of Sep 30, 2023.
- NDA submission initiated for revumenib in R/R KMT2Ar acute leukemia under FDA RTOR; completion expected by year-end 2023.
- Final Phase 1 mNPM1 data: 36% CR/CRh (5/14); 100% of CR/CRh patients MRD-negative; responses durable >22 months.
- Pivotal AUGMENT-101 met primary endpoint: 23% CR/CRh in KMT2Ar acute leukemia; median duration 6.4 months.
- Full-year 2023 expense guidance reduced: R&D now $160-165M (prev $160-175M); total OpEx $225-230M (prev $225-240M).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1395937/000095017023058156/0000950170-23-058156-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1395937/000095017023058156/sndx-20231102.htm
  HTML page:      https://secwatch.observer/filing/0000950170-23-058156

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