Syndax Projects Revuforj Could Exceed $2 Billion in Peak U.S. Net Revenue

Syndax Pharmaceuticals projected Nov. 2 that Revuforj (revumenib) could exceed $2 billion in peak annual U.S. net revenue, with the estimate relying partly on use in frontline leukemia care.

The figure is a company projection, not current sales, and includes anticipated frontline indications. Revuforj’s current FDA-approved uses cover relapsed or refractory disease, so the estimate also includes potential uses beyond the drug’s current label.

Revuforj generated $60.7 million in net revenue for the three months ended Sept. 30, up 90% from a year earlier and 11% from the second quarter. New patients increased about 20% quarter over quarter, while total prescriptions rose 13%. The broader third-quarter results coverage includes Syndax’s other quarterly figures.

Syndax estimates, using claims, prescription and lab data, that about 50% of patients with relapsed or refractory KMT2A-rearranged disease treated with Revuforj proceed to a transplant. About 60% of those patients had resumed treatment afterward. For patients with relapsed or refractory NPM1-mutated disease, the company estimates about 40% proceed to transplant and about half of those resume treatment. These are estimates based on patient-use data, not findings from a prospective trial.

Syndax CEO Michael A. Metzger described post-transplant treatment resumption as “a dynamic that positions the business for long-term growth.”

The current approved uses cover adults and children 1 and older with relapsed or refractory acute leukemia carrying a KMT2A translocation. Revuforj is also approved for patients 1 and older with relapsed or refractory acute myeloid leukemia (AML) involving a susceptible NPM1 mutation when they have no satisfactory alternative treatment options. Frontline use is outside those current indications.

Syndax expects fourth-quarter 2026 updates on Revuforj, including frontline results from the BEAT AML and SAVE trials.