secwatch.observer — SEC 8-K summary
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Issuer:     Syndax Pharmaceuticals Inc (SNDX)
CIK:        0001395937
Form:       8-K
Filed at:   2023-12-12T23:59:59+00:00
Accession:  0000950170-23-069683
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 data for revumenib and axatilimab; BLAs/NDAs expected by year-end 2023
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- Axatilimab AGAVE-201 trial met primary endpoint: 74% ORR at 0.3 mg/kg every two weeks in refractory chronic GVHD; BLA submission planned by year-end 2023.
- Revumenib AUGMENT-101 pivotal trial met primary endpoint: CR/CRh rate 23% in R/R KMT2Ar acute leukemia; NDA submission planned by year-end 2023.
- Combination data showed 100% CRc with revumenib + venetoclax/azacitidine in newly diagnosed mNPM1 or KMT2Ar AML (BEAT AML trial).
- SAVE AML trial all-oral combination achieved 78% CRc in R/R AML; AUGMENT-102 pediatric trial achieved 33% CRc with fludarabine-cytarabine.
- Median OS for revumenib monotherapy in AUGMENT-101 was 8.0 months; 68% of CRc responders achieved MRD negativity.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1395937/000095017023069683/0000950170-23-069683-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1395937/000095017023069683/sndx-20231210.htm
  HTML page:      https://secwatch.observer/filing/0000950170-23-069683

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