Syndax Pharmaceuticals (NASDAQ:SNDX) presented its fourth quarter and full year 2025 financial results on February 26, 2026, showcasing robust commercial momentum from its two flagship oncology products while outlining a clear trajectory toward profitability. The company reported total Q4 2025 revenues of $68.7 million, representing 50% quarter-over-quarter growth and exceeding analyst expectations of $63.13 million by 8.82%. However, the earnings per share of -$0.78 missed forecasts of -$0.59, reflecting continued investment in clinical development programs.
The stock declined 0.34% in regular trading to $20.75 and fell an additional 0.63% in after-hours trading to $20.62, as investors weighed the revenue outperformance against the larger-than-expected loss.
Quarterly Performance Highlights
As shown in the following overview of Syndax’s commercial and pipeline execution, the company achieved significant milestones across both product launches and clinical development programs.
Syndax’s first year as a commercial entity delivered total revenues of $172.4 million, driven by strong uptake of Revuforj (revumenib) for acute leukemia and Niktimvo (axatilimab-csfr) for chronic graft-versus-host disease. The company emphasized achieving three FDA approvals within approximately one year and becoming the first to initiate a pivotal first-line menin inhibitor trial.
Revuforj demonstrated particularly strong momentum following its label expansion, as illustrated in the following performance metrics.
The acute leukemia treatment generated $44.2 million in net revenue during Q4 2025, representing 38% sequential growth. Total prescriptions reached approximately 1,150 in the quarter, up 35% from Q3, while new patient starts grew 20% quarter-over-quarter to approximately 300. For the full year 2025, Revuforj achieved $124.8 million in net revenue with cumulative new patient starts exceeding 1,050 since launch.
Management highlighted that first-year results surpassed typical AML launch benchmarks and solidified the company’s leadership position in menin inhibition. Early indicators suggest at least 30% of new patient starts in Q4 were NPM1-mutated AML patients, reflecting growing adoption beyond the initial KMT2A-rearranged indication.
Niktimvo similarly delivered strong commercial performance, as detailed in the following first-year results.
The chronic GVHD treatment generated $56.0 million in net revenue to partner Incyte in Q4 2025, up 22% sequentially, with Syndax recognizing $19.4 million in collaboration revenue (40% quarterly growth). Full-year 2025 revenues reached $151.6 million to Incyte and $42.4 million to Syndax. The product administered approximately 5,000 infusions in Q4 and attracted more than 300 new patient starts, with approximately 90% of U.S. bone marrow transplant centers having ordered the therapy.
Market Opportunity and Competitive Position
The presentation outlined substantial market opportunities for both commercial products. As shown in the following market analysis, Revuforj targets the largest addressable population among AML precision medicines.
Current Revuforj indications unlock a $2 billion total addressable market in relapsed/refractory acute leukemia, with potential expansion to $5 billion across relapsed/refractory and first-line settings. The company emphasized that menin-dependent AML represents 40-45% of the acute leukemia population, exceeding the addressable markets for FLT3 inhibitors (25-30%) and IDH inhibitors (20-25%).
The breakdown includes approximately 2,000 patients with relapsed/refractory KMT2A-rearranged disease, 4,500 patients with relapsed/refractory NPM1-mutated AML, 3,500 “unfit” first-line patients, and 5,500 “fit” first-line patients with either mutation. Syndax is conducting a comprehensive clinical development program to unlock this opportunity across the acute leukemia treatment continuum.
Pipeline Progress and Clinical Development
The company’s clinical pipeline expanded significantly during 2025, as illustrated in the following comprehensive trial overview.
Syndax is advancing multiple pivotal trials of revumenib in first-line AML settings with dual primary endpoints designed to support both accelerated and full FDA approval. The company achieved a key milestone as the first to initiate a pivotal first-line menin inhibitor trial, positioning itself to potentially be first to market in the frontline setting.
For axatilimab, the company completed enrollment in the MAXPIRe Phase 2 trial evaluating the therapy in idiopathic pulmonary fibrosis, with topline data anticipated in Q4 2026. The following evidence supporting this program demonstrates the biological rationale.
Multiple lines of evidence support axatilimab’s potential in IPF, including data showing higher monocyte levels correlate with shorter overall survival in IPF patients, preclinical models demonstrating reduction in lung fibrosis, and remarkable antifibrotic activity observed in chronic GVHD across all organs studied. Notable response rates were achieved in fibrosis-dominated organs, including 47% in lungs and 27% in skin.
The MAXPIRe trial design, detailed in the following schematic, enrolled 135 patients in a randomized, double-blind, placebo-controlled study.
Patients are randomized 2:1 to receive axatilimab or placebo, stratified by background antifibrotic therapy use. The primary endpoint measures the annualized rate of decline in forced vital capacity over 26 weeks, with secondary endpoints including disease progression and quality of life measures. This represents a significant expansion opportunity, as IPF affects approximately 150,000 U.S. patients and 280,000 worldwide.
Detailed Financial Analysis
The following financial summary provides a comprehensive view of Syndax’s fiscal year 2025 performance and balance sheet position.
Total revenues of $68.7 million in Q4 2025 represented a dramatic acceleration from $7.7 million in Q4 2024, driven by the launches of both Revuforj and Niktimvo during 2025. For the full year, total revenues reached $172.4 million compared to $23.7 million in 2024.
Operating expenses totaled $131.3 million in Q4 2025, up from $104.0 million in the prior-year quarter, reflecting increased commercial infrastructure and ongoing clinical trial costs. Research and development expenses were $78.6 million in Q4, while selling, general and administrative expenses reached $49.9 million. Full-year 2025 operating expenses totaled $445.4 million.
The net loss of $68.0 million in Q4 2025 represented a 27.8% improvement from the $94.2 million loss in Q4 2024, despite significantly higher operating expenses, due to the substantial revenue growth. Full-year 2025 net loss of $285.4 million improved from $318.8 million in 2024.
Syndax ended 2025 with $394.1 million in cash and equivalents, providing a solid foundation for its path to profitability. The company issued guidance for 2026 research and development plus SG&A expenses of approximately $400 million, excluding $50 million in expected stock option expense, indicating stable cost structure as revenues continue to grow.
Forward-Looking Statements
Management outlined ambitious milestones for 2026, building on the strong commercial and clinical execution achieved in 2025. Key anticipated events include advancing global enrollment in pivotal first-line trials of revumenib, presenting industry-leading clinical data including first-line, maintenance, and real-world evidence at major medical meetings, and reporting topline Phase 2 axatilimab data in IPF in Q4 2026.
The company also plans to initiate the RAVEN first-line trial of revumenib in fit KMT2A-rearranged patients in the second half of 2026 and begin a program to generate proof-of-principle clinical data with revumenib in myelofibrosis, further expanding the potential applications of its menin inhibitor platform.
CEO Michael Metzler commented during the earnings call, “Our first year as a commercial company has been transformative, with our innovative therapies gaining significant traction in the market. We are confident in our path to profitability, driven by strong demand for Revuforj and Niktimvo.”
The company emphasized that it expects to reach profitability without requiring additional capital, supported by its strong balance sheet, growing product revenues, and stable expense outlook. With both products demonstrating strong prescriber adoption, extended treatment durations, and expanding usage across their respective indications, Syndax appears well-positioned for continued commercial momentum in 2026 and beyond.
Full presentation:
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