Syndax Pharmaceuticals NASDAQ: SNDX reported third-quarter 2026 total revenue of $83.3 million, an 82% increase from the prior-year period, as sales of its Revuforj leukemia treatment and collaboration revenue from Niktimvo continued to rise.
Revuforj net revenue reached $60.7 million during the quarter, up 90% year over year and 11% sequentially. Niktimvo collaboration revenue was $22.6 million. Chief Executive Officer Michael Metzger said the company is moving toward profitability while continuing to invest in commercial expansion and clinical development.
Revuforj Growth Driven by New Patients and Post-Transplant Use
Chief Commercial Officer Steve Closter said Revuforj prescriptions totaled approximately 1,700 in the third quarter, a 13% sequential increase and roughly double the level of a year earlier. The company added about 300 new patients, representing approximately 20% quarter-over-quarter growth in new starts.
Revuforj is approved for relapsed or refractory acute leukemia involving NPM1 or KMT2A alterations. Syndax said it expects the medicine to account for more than 80% of menin inhibitor class revenue for the quarter and described it as the market leader across age groups.
About half of new Revuforj patients during the quarter were NPM1 patients, according to the company. Syndax estimated that NPM1 use accounted for more than 35% of Revuforj’s third-quarter net revenue, compared with more than 30% in the preceding quarter.
Management highlighted increasing use of Revuforj before and after stem cell transplant. Syndax said approximately 40% of its NPM1 patients were proceeding to transplant, with about half subsequently resuming therapy. Among KMT2A patients, approximately 50% proceeded to transplant and about 60% resumed treatment afterward.
Metzger characterized transplant-related pauses in therapy as a near-term revenue headwind but a longer-term benefit as more patients return to treatment in the post-transplant setting. He said the company expects the impact of this patient “stack” to become more meaningful in 2027.
Patients receiving Revuforj after transplant have averaged at least nine months of therapy so far, while patients not receiving transplants but remaining on treatment have averaged more than seven months, Closter said. Syndax expects more KMT2A patients to resume treatment following transplant over time.
The company said more than 620 accounts have ordered Revuforj, up about 8% from the previous quarter. More than 90% of targeted tier 1 and tier 2 accounts have ordered the drug, and formulary coverage is in place for nearly all covered lives in both approved indications.
Niktimvo Revenue and Frontline Studies
Niktimvo net revenue was $67 million in the third quarter, up 47% from a year earlier and 12% sequentially. Syndax receives 50% of Niktimvo net profit through its collaboration arrangement, resulting in $22.6 million of collaboration revenue during the quarter.
The treatment, which is used in chronic graft-versus-host disease, added more than 300 new patients in the quarter, with approximately 6,350 infusions administered. Syndax said Niktimvo has captured about one-third of the third-line-plus chronic GVHD market and is seeing increased use in third-line treatment.
Chief Financial Officer Keith Goldan said Niktimvo’s margin contribution was approximately 34% in the quarter, aided slightly by a one-time, nonrecurring adjustment. Going forward, the company expects the contribution margin to remain in the low- to mid-30% range, above its previous expectation of 25% to 30%.
In research and development, Syndax now expects to report top-line results from a phase II study of axatilimab, the active ingredient in Niktimvo, in combination with ruxolitinib for newly diagnosed chronic GVHD at a medical meeting in the first quarter of 2027. The company had previously expected the results earlier, but said the revised timing would allow for a more mature dataset including event-free survival. Top-line results from a phase III trial pairing axatilimab with corticosteroids are expected in early 2028.
Upcoming Leukemia Data and Pipeline Plans
Syndax plans to present several Revuforj datasets during the fourth quarter, including at the American Society of Hematology annual meeting in December. The presentations are expected to include frontline combination data from the BEAT AML and SAVE studies, updates from a frontline trial with intensive chemotherapy, post-transplant data and real-world evidence.
Head of R&D and Chief Medical Officer Nick Botwood said updated BEAT AML and SAVE results will feature longer follow-up and larger patient cohorts than prior presentations. The company said earlier data from those studies showed response rates approaching 90% and complete minimal residual disease negativity among responders by flow cytometry.
Syndax is also advancing two pivotal frontline AML trials. EVOLVE-2, in patients unfit for intensive chemotherapy, has dual primary endpoints of complete response and overall survival. REVEAL, in patients eligible for intensive chemotherapy, has dual primary endpoints of minimal residual disease-negative complete response and event-free survival. Management did not provide enrollment-completion timelines for either study.
Beyond its marketed medicines, Syndax expects to submit an investigational new drug application for SNDX-4321, a mutant-selective allosteric EGFR inhibitor for non-small cell lung cancer, by the end of 2026. It expects SNDX-62122, a next-generation menin inhibitor for myelofibrosis, to enter clinical development next year. A separate phase I/II proof-of-principle trial of revumenib in myelofibrosis is expected to begin in the fourth quarter, with initial data anticipated in the second half of 2027.
Cash Position and CFO Transition
Syndax ended the third quarter with $551 million in cash, cash equivalents and investments. The company maintained its 2026 guidance for combined research and development and selling, general and administrative expenses of approximately $400 million, excluding an estimated $50 million in non-cash stock-based compensation.
Goldan said the company believes its cash resources and rising revenue from its two marketed medicines are sufficient to support its commercial and research priorities.
The company also announced that Goldan will retire after more than four years as CFO. Aaron Ondrey is scheduled to become CFO effective Nov. 9. Goldan said his decision was personal and that he plans to spend more time with family, pursue hobbies and undertake philanthropic work.
About Syndax Pharmaceuticals (NASDAQ:SNDX)
Syndax Pharmaceuticals, Inc NASDAQ: SNDX is a biopharmaceutical company focused on developing and commercializing therapies for cancer and immune-related diseases. Founded in 2005 and headquartered in Waltham, Massachusetts, the company develops medicines designed to address genetically defined cancers and serious complications associated with cancer treatment.
Syndax's lead product is Revuforj (revumenib), an oral menin inhibitor approved in the United States for the treatment of relapsed or refractory acute leukemia with a KMT2A translocation in eligible adults and children.
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