Multiple Approvals and Successful Launches
Syndax launched 2 first- and best-in-class medicines in 2025 and achieved its third FDA approval within ~1 year, demonstrating strong commercial and R&D execution.
Revuforj: Robust Revenue and Quarterly Acceleration
Revuforj generated $124.8M in net revenue in 2025; Q4 Revuforj net revenue was $44.2M, up 38% quarter-over-quarter, with total prescriptions up ~35% QoQ and new patient starts up ~20% in Q4.
Revuforj Market Penetration and Label Expansion (NPM1)
Approximately 1,050 patients treated commercially since launch; approaching ~50% penetration of the KMT2A incident population in year one. NPM1 label expansion triples the annual addressable population to ~6,500 patients and formulary coverage in NPM1 reached ~97% of lives within 4 months of approval; NPM1 represented roughly 30% of new starts in Q4 and management expects this to grow materially.
Niktimvo: Strong Launch Performance and Contribution
Niktimvo reported $56M in Q4 net revenue (+22% QoQ) and ~$151.6M in 2025 net revenue (first 11 months). Syndax recorded $42.4M in collaboration revenue from Niktimvo in 2025. To date ~13,500 infusions have been administered to >1,400 patients, with persistency ~60%–70% at month 10 and ~90% of U.S. bone marrow transplant centers having prescribed the drug.
Company-Level Financials and Cash Position
Total Syndax revenue in 2025 was $172.4M. Cash, cash equivalents and marketable securities were $394M at year-end 2025. Management expects to reach profitability without additional capital.
Pipeline Advancement and Clear Clinical Catalysts
Enrollment underway in pivotal frontline trials for revumenib (EVOLVE-2, REVEAL, RAVEN); MAXPIRe (axatilimab in IPF) completed enrollment (~135 patients) with topline data expected Q4 2026; Phase III axatilimab chronic GVHD trial (steroids combo) topline expected early 2028 and a Phase II (ruxolitinib combo) early 2027.
Real-World Evidence and Investigator Data Supporting Efficacy
Real-world evidence: Moffitt reported ORR ~77% and MRD negativity ~75% in relapsed/refractory patients treated primarily with revumenib combination regimens; investigator-maintenance and post-transplant data (MD Anderson, City of Hope) reported favorable tolerability and encouraging outcomes.
Expense Guidance and Stability
Management guided 2026 R&D + SG&A of approximately $400M (excluding ~$50M estimated noncash stock compensation) and expects expenses to be relatively flat quarter-to-quarter, indicating predictable investment levels into commercialization and development.