Syndax Q3 Revenue Hits $83.3 Million on Drug Growth

Syndax Pharmaceuticals Inc. (SNDX) reported a sharp increase in third-quarter 2026 revenue as Revuforj prescriptions continued to grow and its share of Niktimvo commercial profit increased. Total revenue reached $83.3 million, up from $45.9 million a year earlier, while the net loss narrowed to $49.4 million from $60.7 million.

Revuforj generated $60.7 million in net product revenue, rising 90% year over year and 11% from the second quarter. Total prescriptions increased approximately 100% from the prior-year period and 13% sequentially to about 1,700. Syndax also recorded roughly 300 new patient starts, a 20% quarter-over-quarter increase.

The company said Revuforj has now delivered seven consecutive quarters of double-digit sequential growth in both net revenue and total prescriptions. It attributed the latest performance to uptake across the drug’s two indications and a growing number of patients continuing treatment after hematopoietic stem cell transplantation.

Revuforj adoption expands

NPM1-mutated acute myeloid leukemia accounted for about half of new Revuforj patients during the quarter and more than 35% of product revenue. Based on claims, prescription and laboratory data, Syndax estimated that approximately 40% of use was in combination regimens and about 75% occurred in second- or third-line treatment.

The presentation also indicated substantial transplant activity among patients treated for relapsed or refractory disease. About 50% of KMT2A-rearranged patients proceeded to transplant, with roughly 60% resuming treatment afterward. For NPM1-mutated patients, the corresponding estimates were approximately 40% and 50%.

Syndax reported formulary coverage for both Revuforj indications across 99% of covered lives. More than 620 accounts had prescribed the drug by the end of the quarter, an increase of 8% from the second quarter, while more than 90% of the company’s Tier 1 and Tier 2 accounts had been activated.

Niktimvo collaboration revenue grows

Niktimvo net revenue reported by collaborator Incyte reached $67.4 million, up 47% year over year and 12% sequentially. More than 300 patients started treatment during the quarter, and approximately 6,350 infusions were administered.

Syndax recognizes 50% of Niktimvo’s net commercial profit, defined as net revenue recorded by Incyte less cost of sales and commercial expenses. Its third-quarter collaboration revenue was $22.6 million, increasing 63% from a year earlier and 25% from the second quarter. The company said that revenue stream is currently annualizing at more than $90 million.

Pipeline plans center on earlier treatment settings

Syndax is advancing revumenib, marketed as Revuforj, across multiple stages of acute leukemia treatment, including frontline therapy, measurable residual disease relapse and post-transplant maintenance. The company expects new data in the fourth quarter of 2026 from frontline combination studies including BEAT AML, SAVE and study 708, as well as from the INTERCEPT MRD relapse study, transplant settings and real-world analyses.

Global enrollment is continuing in pivotal frontline revumenib trials. Syndax also plans to publish data in relapsed or refractory NUP98-rearranged disease during the fourth quarter and submit the publication for consideration in clinical guidelines.

Beyond acute leukemia, the company expects to begin a Phase 1/2 proof-of-principle trial of revumenib in myelofibrosis in the fourth quarter of 2026, with initial data targeted for the second half of 2027. A Phase 1 trial of next-generation menin inhibitor SNDX-62122 is expected to start in the fourth quarter of 2027.

For Niktimvo, two combination studies are evaluating axatilimab with ruxolitinib or corticosteroids in frontline chronic graft-versus-host disease. Topline Phase 2 data for the ruxolitinib combination are expected at a medical meeting in the first quarter of 2027, while topline Phase 3 data for the corticosteroid combination are planned for early 2028.

Syndax also 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. A Phase 1 trial is planned for 2027, with initial data anticipated in early 2028.

Expenses rise as loss narrows

Research and development expense increased to $67.5 million from $56.3 million a year earlier, while selling, general and administrative expense declined slightly to $43.7 million from $44.9 million. Cost of product sales rose to $14 million from $2.1 million, bringing total operating expenses to $125.2 million compared with $103.3 million in the prior-year quarter. Other net expense was $7.5 million, versus $3.3 million a year earlier.

Syndax ended September with $551.1 million in cash, cash equivalents and short- and long-term investments, and 90 million shares outstanding. Its 2026 guidance calls for combined R&D and SG&A expense of $400 million, excluding $50 million of expected stock-option expense.

The company cautioned that its development and commercial plans remain subject to clinical safety and efficacy results, enrollment and trial-site activation rates, regulatory outcomes, competition, collaborator performance and potential manufacturing or supply-chain disruptions. Macroeconomic conditions, litigation and other disputes could also cause actual results or development timelines to differ from current expectations.