---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-23-033937"
form_type: "8-K"
ticker: "SNDX"
cik: "0001395937"
company_name: "Syndax Pharmaceuticals Inc"
filed_at: "2023-07-24T23:59:59+00:00"
generated_at: "2026-06-13T04:07:54.736360+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Syndax/Incyte axatilimab hits primary endpoint in cGVHD trial; 74% ORR at 0.3 mg/kg dose

## Summary
- AGAVE-201 met primary endpoint: ORR 74% (0.3 mg/kg Q2W), 67% (1.0 mg/kg), 50% (3.0 mg/kg Q4W).
- At 0.3 mg/kg dose, 60% of responders maintained response at 12 months; median DOR not reached.
- Patients had median 4 prior therapies; 54% with ≥4 organs involved; 45% lung involvement.
- Syndax and Incyte intend to file BLA with FDA by year-end 2023.
- Safety consistent with CSF-1R inhibition; 38% SAEs in 0.3 mg/kg group; 6.3% discontinued.

## SEC filing metadata
- accession: 0000950170-23-033937
- form_type: 8-K
- ticker: SNDX
- cik: 0001395937
- company_name: Syndax Pharmaceuticals Inc
- filed_at: 2023-07-24T23:59:59+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/1395937/000095017023033937/0000950170-23-033937-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1395937/000095017023033937/sndx-20230724.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-23-033937
- JSON: https://secwatch.observer/filing/0000950170-23-033937.json
- Plain text: https://secwatch.observer/filing/0000950170-23-033937.txt

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