Syndax Pharmaceuticals (NASDAQ: SNDX) is a clinical-stage biopharmaceutical company that develops and commercializes targeted therapies for hematologic malignancies and other serious diseases. Revenue comes from product sales of two FDA-approved medicines, REVUFORJ (revumenib) and NIKTIMVO (axatilimab-csfr), plus milestone and royalty payments under license agreements. REVUFORJ, an oral first-in-class menin inhibitor approved by the FDA in November 2024, targets relapsed or refractory acute leukemia with KMT2A translocations or NPM1 mutations. NIKTIMVO, a monoclonal antibody targeting CSF-1R, was launched commercially in the U.S. in late January 2025 for chronic graft-versus-host disease, co-commercialized with collaboration partner Incyte. Syndax holds global rights to revumenib and licenses axatilimab rights in partnership with Incyte. Multiple ongoing clinical trials, including the Phase 3 EVOLVE-2 trial initiated in the first quarter of 2025, are evaluating revumenib in frontline acute leukemia settings.
REVUFORJ (revumenib): oral, first-in-class menin inhibitor, FDA-approved November 2024 for R/R acute leukemia with KMT2A translocation or NPM1 mutation. NIKTIMVO (axatilimab-csfr): CSF-1R-targeting monoclonal antibody, launched commercially in the U.S. in late January 2025 for chronic graft-versus-host disease, co-commercialized with Incyte.
Product sales from REVUFORJ and NIKTIMVO in the U.S., plus potential milestone and royalty payments under license agreements, including the collaboration and license agreement with Incyte for axatilimab.
Adult and pediatric patients with relapsed or refractory acute leukemia (KMT2A translocation, NPM1 mutation) and chronic graft-versus-host disease patients. Prescribers include oncologists and hematologists at treatment centers in the U.S.
Primary commercial operations in the U.S. as of the 10-K filed 2026-02-26. Global rights held for revumenib; axatilimab commercialized in the U.S. in partnership with Incyte.
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