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

Syndax Pharmaceuticals Inc

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.

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