---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-250052"
form_type: "8-K"
ticker: "SNDX"
cik: "0001395937"
company_name: "Syndax Pharmaceuticals Inc"
filed_at: "2025-10-24T23:59:59+00:00"
generated_at: "2026-05-17T02:19:16.268682+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Syndax receives FDA approval for Revuforj in NPM1-mutated R/R AML, second indication in <1 year

## Summary
- FDA approved Revuforj (revumenib) for R/R AML with NPM1 mutation in patients aged ≥1 year.
- CR+CRh rate of 23% (15/65); median time to response 2.8 months; median duration 4.5 months.
- First and only FDA-approved menin inhibitor for both NPM1-m AML and KMT2A-r acute leukemia.
- Included in NCCN Guidelines (Category 2A) for R/R NPM1m AML; commercial launch ongoing via SyndAccess.
- Company to host conference call on Oct 24, 2025 at 2:30 p.m. ET.

## SEC filing metadata
- accession: 0001193125-25-250052
- form_type: 8-K
- ticker: SNDX
- cik: 0001395937
- company_name: Syndax Pharmaceuticals Inc
- filed_at: 2025-10-24T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1395937/000119312525250052/0001193125-25-250052-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1395937/000119312525250052/sndx-20251024.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-250052
- JSON: https://secwatch.observer/filing/0001193125-25-250052.json
- Plain text: https://secwatch.observer/filing/0001193125-25-250052.txt

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