---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-23-069683"
form_type: "8-K"
ticker: "SNDX"
cik: "0001395937"
company_name: "Syndax Pharmaceuticals Inc"
filed_at: "2023-12-12T23:59:59+00:00"
generated_at: "2026-06-07T14:05:18.286501+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Syndax reports positive pivotal data for revumenib and axatilimab; BLAs/NDAs expected by year-end 2023

## Summary
- 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.

## SEC filing metadata
- accession: 0000950170-23-069683
- form_type: 8-K
- ticker: SNDX
- cik: 0001395937
- company_name: Syndax Pharmaceuticals Inc
- filed_at: 2023-12-12T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1395937/000095017023069683/0000950170-23-069683-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1395937/000095017023069683/sndx-20231210.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-23-069683
- JSON: https://secwatch.observer/filing/0000950170-23-069683.json
- Plain text: https://secwatch.observer/filing/0000950170-23-069683.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.