secwatch.observer — SEC 8-K summary
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Issuer:     Syndax Pharmaceuticals Inc (SNDX)
CIK:        0001395937
Form:       8-K
Filed at:   2025-10-24T23:59:59+00:00
Accession:  0001193125-25-250052
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1395937/000119312525250052/0001193125-25-250052-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1395937/000119312525250052/sndx-20251024.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-250052

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer