secwatch.observer — SEC 8-K summary
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Issuer:     Syndax Pharmaceuticals Inc (SNDX)
CIK:        0001395937
Form:       8-K
Filed at:   2022-11-03T23:59:59+00:00
Accession:  0000950170-22-021838
Event type: earnings
Sentiment:  positive
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Syndax Q3 net loss $35.4M; revumenib Phase 1 shows 30% CR/CRh rate, 9.1 mo median durability
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- Net loss $35.4M ($0.58 per share) vs $20.6M ($0.40) prior year; cash $337.8M at Sep 30.
- Revumenib Phase 1 CR/CRh rate 30% (18/60); median response 9.1 months; 75% of transplanted patients in remission.
- Enrollment complete in pivotal AGAVE-201 trial of axatilimab in cGVHD; topline data expected mid-2023.
- Lowered FY 2022 R&D expense guidance to $115-125M and total op ex to $145-155M, citing axatilimab cost sharing.
- On track for revumenib NDA and axatilimab BLA filings by end of 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1395937/000095017022021838/0000950170-22-021838-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1395937/000095017022021838/sndx-20221103.htm
  HTML page:      https://secwatch.observer/filing/0000950170-22-021838

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