Syndax Expects Revuforj Annual U.S. Revenue to Exceed $2 Billion
Key Facts
Syndax expects annual U.S. revenue for Revuforj to exceed $2 billion, based on the peak use it anticipates in the market, including potential future indications in earlier treatment settings. The estimate comes as the drug generated $60.7 million in net revenue in the third quarter of 2026, up 90% year over year and 11% from the second quarter. The company said revenue and prescription growth reflect uptake in its two approved indications, along with some patients resuming treatment after stem cell transplant. Chief Executive Michael Metzger said the trend "positions the commercial business for long-term growth as average treatment duration extends." Use in earlier treatment settings is not currently approved sales, but part of the company's view of the drug's future revenue potential.
Quarterly revenue growth accelerated from the previous quarter, when Revuforj generated $54.7 million in net revenue, up 12% from the first quarter and 91% from the second quarter of 2025. In the third quarter, the number of new patients starting treatment rose about 20%, while total prescriptions increased 13% compared with the second quarter of 2026. Syndax links these indicators to broader use in the drug's two approved indications. It also said growing numbers of patients with relapsed or refractory leukemia are proceeding to stem cell transplant and then resuming treatment afterward. This pattern gives the company a path to extend treatment duration for some patients, which Metzger linked to long-term commercial growth.
The estimates for resuming treatment after transplant are based on the company's claims data. The data indicate that about 50% of patients with KMT2A-rearranged leukemia who received Revuforj proceed to stem cell transplant, and about 60% of those patients resume treatment after transplant. Among patients with an NPM1 mutation who received the drug, about 40% proceed to transplant, and about 50% of them resume treatment afterward. These percentages indicate that transplant does not necessarily end treatment use in either group. The company said revenue and prescription growth reflect an increasing number of patients returning to treatment after transplant.
Revuforj still accounts for part of Syndax's overall business, with the company reporting revenue of $83.3 million in the third quarter of 2026, including $60.7 million in net revenue from the drug and $22.6 million in collaboration revenue related to Niktimvo. Net loss attributable to common stockholders narrowed to $49.4 million, or $0.55 per share, compared with a loss of $60.7 million, or $0.70 per share, in the third quarter of 2025. As of September 30, 2026, the company had $551.1 million in cash and cash equivalents and short- and long-term investments. Syndax is continuing to build its commercial business around Revuforj, alongside collaboration revenue from Niktimvo. The company's shares, listed under the ticker SNDX, closed at $13.1 on November 2, 2026.
Revuforj received U.S. Food and Drug Administration approval on November 15, 2024, to treat relapsed or refractory acute leukemia associated with KMT2A translocation in adults and children aged 1 year and older. The efficacy assessment for this indication was based on 104 patients, and the rate of complete remission or complete remission with partial hematologic recovery was 21.2%, with a median duration of 6.4 months. On October 24, 2025, the agency expanded the approval to patients aged 1 year and older with relapsed or refractory acute myeloid leukemia and a susceptible NPM1 mutation who have no satisfactory alternative treatment options. The rate of complete remission or complete remission with partial hematologic recovery in the assessment of this indication was about 23.1%, with a median response duration of 4.5 months. The two approved indications cover different genetic groups, while the company presents expansion into earlier treatment settings as a future opportunity.
Syndax expects to present new or updated Revuforj data in the fourth quarter of 2026, including data on maintenance therapy after transplant and real-world evidence from multiple centers. It also expects to start the Phase 2 MINTENT trial in the first quarter of 2027. The trial will be randomized and placebo-controlled, and will focus on Revuforj as maintenance therapy after stem cell transplant. The company has placed the post-transplant setting among its upcoming milestones. The commercial estimate of more than $2 billion remains tied to Syndax's expectations for peak U.S. use, while the anticipated data and trial represent subsequent steps in developing this approach.