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Syndax Announces FDA Priority Review of sNDA for Revuforj® (revumenib) in Relapsed or Refractory mNPM1 Acute Myeloid Leukemia

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Reimagining Cancer Treatment

We are a commercial stage oncology innovator seeking to develop first-in-class therapies in areas of significant unmet need such as acute leukemia and chronic graft-versus-host disease. Our team is committed to adhering to scientific excellence and dedicated to serving the patient community by delivering therapeutics that provide meaningful and differentiated clinical results and address urgent unmet need.

Beyond its initial indication, Syndax is also investigating revumenib in other genetically defined acute leukemias such as those with an NPM1 mutation, where a pivotal trial is ongoing.

Revumenib

In addition to its first indication, Syndax aims to investigate axatilimab in earlier lines of therapy in combination with standard of care agents and in potential indications such as idiopathic pulmonary fibrosis, where a Phase 2 clinical trial is ongoing.

Axatilimab

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Highlights of our pipeline include revumenib and axatilimab, which were both approved in the U.S. in 2024. Syndax&#8217;s pipeline extends beyond the initial indication, including clinical trials investigating use in earlier lines of therapy, maintenance therapy and in combination with other approved therapies.

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Please see Full Prescribing Information, including BOXED WARNING <a style="color: #ce0037;" href="https://cms.syndax.com/revuforj-full-prescribing-info/">here</a>.