Syndax Pharmaceuticals NASDAQ: SNDX reported second-quarter 2026 total revenue of $72.8 million, up 92% from the prior-year period, as sales of its leukemia treatment Revuforj and chronic graft-versus-host disease therapy Niktimvo continued to grow.
Chief Executive Officer Michael Metzger said the company’s two marketed medicines generated a combined $115 million in second-quarter net sales. Revuforj recorded $54.7 million in net revenue, while Niktimvo generated $60 million in net sales reported by Syndax’s partner Incyte. Syndax recognized $18.1 million in Niktimvo collaboration revenue, representing 30% of the therapy’s reported net revenue.
Revuforj Growth Driven by Duration of Treatment
Revuforj net revenue rose 91% year over year and 12% sequentially to $55 million. Total prescriptions increased 15% from the first quarter to approximately 1,500, according to Chief Commercial Officer Steve Closter.
The medicine has treated more than 1,600 commercial patients since launch, including 250 new patients in the second quarter. Closter said Syndax saw some quarter-to-quarter fluctuation in new patient starts, which he attributed to the variability inherent in rare diseases, clinical-trial activity and physician treatment choices when more than one therapy may be considered based on a patient’s mutation profile.
Still, company executives emphasized that growing treatment duration is becoming an increasingly important contributor to Revuforj revenue. Syndax said approximately 50% of KMT2A patients receiving Revuforj proceed to stem-cell transplant. Of those patients, about 50% have resumed therapy after a three- to six-month pause, compared with an estimated 45% in the previous quarter.
Closter said Syndax expects 70% to 80% of transplant patients may eventually resume therapy for one to two years, based on physician feedback and clinical and real-world experience. Patients who have resumed treatment after transplant are averaging at least nine months on therapy, while patients who do not undergo transplant are averaging more than seven months of treatment.
Revuforj’s use in NPM1-mutated acute myeloid leukemia is also expanding. NPM1 accounted for at least 40% of new patients in the second quarter and more than 30% of Revuforj net revenue. Syndax estimates that fewer than 15% of the approximately 4,500 annual relapsed or refractory NPM1 patients have received a menin inhibitor, leaving room for further market penetration.
- More than 580 accounts had ordered Revuforj, up 11% sequentially.
- Nearly 90% of the company’s Tier 1 and Tier 2 accounts had ordered the drug, compared with 70% before the NPM1 approval.
- Revuforj had formulary coverage for 98% of covered lives across both indications at the end of the quarter.
- Claims data showed that 75% of Revuforj use was in second- and third-line treatment, with about 40% of use in combination regimens.
Metzger said Syndax now expects Revuforj could generate more than $2 billion in peak annual U.S. net revenue if it reaches anticipated frontline AML indications. The company said it believes it is positioned to be the first menin inhibitor to report pivotal frontline AML data.
Niktimvo Advances in Chronic GVHD
Niktimvo net revenue increased 67% year over year and 9% sequentially to $60 million. More than 300 new patients began treatment during the quarter, while approximately 5,750 infusions were administered.
Closter said Niktimvo has captured about one-third of the third-line-and-later chronic GVHD market within roughly 18 months of launch. The product is seeing continued adoption in fourth-line treatment and growing uptake in third-line use, he said.
Syndax reported that 60% to 70% of commercial patients have remained on Niktimvo for at least 12 months. The company said its clinical-trial experience indicates that treatment duration may be measured in years for a meaningful portion of patients.
The company expects to report top-line results during the fourth quarter from a Phase II trial of axatilimab, Niktimvo’s active ingredient, in idiopathic pulmonary fibrosis, known as the MAXPIRe trial. It also expects fourth-quarter results from a Phase II study evaluating axatilimab combined with ruxolitinib in frontline chronic GVHD.
Clinical Data and Pipeline Plans
Head of Research and Development and Chief Medical Officer Nick Botwood highlighted data presented at ASCO and EHA, including post-transplant maintenance findings in heavily pretreated patients with KMT2A, NPM1 or NUP98 alterations who resumed revumenib after transplant. The analysis showed a two-year overall survival rate of 90%, Botwood said, though he noted that the study was not randomized.
Syndax also cited results from the Phase I/II SAVE trial, published in the Journal of Clinical Oncology, evaluating an all-oral combination of revumenib, venetoclax and decitabine or azacitidine in patients with NPM1, KMT2A or NUP98 AML. The company said 88% of participants achieved an overall response, 80% of evaluable complete-response-with-count-recovery responders achieved measurable residual disease negativity, and 45% proceeded to transplant.
In the fourth quarter, Syndax expects to publish data in relapsed or refractory NUP98-rearranged acute leukemia. At EHA, the company presented data from 25 heavily pretreated patients showing a 28% overall response rate, with 43% of responders proceeding to transplant.
The company also outlined development plans for two newer pipeline programs. SNDX-4321 is a mutant-selective, central nervous system-penetrant allosteric EGFR inhibitor being developed for non-small cell lung cancer. Syndax expects to submit an investigational new drug application by the end of 2026 and anticipates an initial monotherapy activity assessment in early 2028.
SNDX-62122 is a next-generation menin inhibitor being developed for myelofibrosis. Syndax expects to submit an IND and start a Phase I trial in 2027. A 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 Expense Outlook
Chief Financial Officer Keith Goldan said Syndax ended the quarter with $575 million in cash equivalents and investments. That amount included $244 million in net proceeds from a June issuance of $250 million in 2.25% convertible notes.
The company reaffirmed its expectation for approximately $400 million in 2026 research and development plus selling, general and administrative expenses, excluding an estimated $550 million in non-cash stock compensation expense. Goldan said Syndax expects Niktimvo collaboration margin contribution to remain in the 25% to 30% range in the near term and rise over time as sales expand.
Management said the company is funded to execute its commercial and research priorities and expects growing revenue from Revuforj and Niktimvo to support its path toward profitability.
About Syndax Pharmaceuticals (NASDAQ:SNDX)
Syndax Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for the treatment of cancer. Headquartered in Waltham, Massachusetts, the company focuses on small-molecule inhibitors that target key epigenetic and protein interaction pathways. Syndax's research platform aims to enhance the effectiveness of existing therapies and address high unmet medical needs in oncology.
The company's lead investigational candidate, entinostat, is a selective class I histone deacetylase (HDAC) inhibitor being evaluated for multiple solid tumor and hematologic indications.
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