---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-127708"
form_type: "8-K"
ticker: "SNDX"
cik: "0001395937"
company_name: "Syndax Pharmaceuticals Inc"
filed_at: "2024-11-18T23:59:59+00:00"
generated_at: "2026-05-29T22:57:10.868483+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.95
calibrated_materiality_score: 0.95
confidence: "high"
source: SEC EDGAR
---

# Syndax receives FDA approval for Revuforj as first menin inhibitor for KMT2A-translocated acute leukemia

## Summary
- FDA approved Revuforj for R/R acute leukemia with KMT2A translocation in patients aged 1+ years.
- Efficacy: CR+CRh rate 21% (22/104), median duration 6.4 months, median time to remission 1.9 months.
- Safety: common AEs include hemorrhage, febrile neutropenia, differentiation syndrome; 12% discontinued.
- Commercial launch of 110/160 mg tablets expected Nov 2024; 25 mg tablets in early 2025.
- SyndAccess patient support program launched; oral solution available via expanded access for patients <40 kg.

## SEC filing metadata
- accession: 0000950170-24-127708
- form_type: 8-K
- ticker: SNDX
- cik: 0001395937
- company_name: Syndax Pharmaceuticals Inc
- filed_at: 2024-11-18T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.95
- calibrated_materiality_score: 0.95
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1395937/000095017024127708/0000950170-24-127708-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1395937/000095017024127708/sndx-20241115.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-127708
- JSON: https://secwatch.observer/filing/0000950170-24-127708.json
- Plain text: https://secwatch.observer/filing/0000950170-24-127708.txt

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