Syndax (SNDX) Q4 2025: Revuforge Net Revenue Climbs 38% on Expanded AML Penetration

2026-02-26 | By EarningsIQ Research

Syndax’s dual launch momentum accelerated in Q4, as Revuforge captured wider AML adoption and Nictimbo sustained double-digit growth. Expanding post-transplant use and label-driven market reach set the stage for a step-change in duration and penetration in 2026. With stable expenses and robust cash, Syndax targets profitability and deep pipeline execution as it pushes into larger addressable oncology and fibrosis markets.

Summary

  • Revuforge Uptake Accelerates: New AML indications and post-transplant adoption fuel robust prescription and revenue gains.
  • Nictimbo Outpaces Benchmarks: Chronic GVHD franchise delivers high persistency and rapid prescriber expansion.
  • Pipeline Execution in Focus: Upcoming frontline and IPF data readouts could unlock multi-billion dollar opportunities.

Performance Analysis

Syndax’s first full year as a commercial-stage company delivered $172 million in total revenue, anchored by two key launches: Revuforge, a menin inhibitor for acute myeloid leukemia (AML), and Nictimbo, a chronic graft-versus-host disease (GVHD) therapy. Revuforge net revenue surged 38% sequentially in Q4, reflecting both expanded label access into NPM1-mutated AML and rising post-transplant maintenance use. Notably, new patient starts grew 20% quarter-on-quarter, with about 30% now coming from the new NPM1 indication, a trend management expects to accelerate toward parity with KMT2A as the year progresses.

Nictimbo’s Q4 net revenue climbed 22% sequentially, with persistency rates of 60% to 70% at month 10, and nearly all U.S. bone marrow transplant centers now prescribing. The company’s 50% share in Nictimbo collaboration revenue reached $42 million for the year, with margin contribution expected to rise as sales outpace fixed expenses. Operating leverage is emerging, as expense guidance for 2026 remains flat year-over-year, positioning Syndax to approach profitability without new capital raises.

  • Label Expansion Drives Scale: Revuforge’s NPM1 approval tripled the annual addressable AML population to 6,500, underpinning prescription and revenue growth.
  • Post-Transplant Maintenance Ramps: The proportion of KMT2A patients resuming therapy post-transplant rose to 40-45%, supporting longer treatment durations.
  • Combination Therapy Adoption: 40% of Revuforge use is now in combination regimens, signaling comfort and potential for further duration gains as frontline trials mature.

Growth in both franchises is being driven by real-world adoption, rapid payer access, and deepening prescriber engagement, with management signaling further upside from ongoing clinical and commercial expansion in 2026.

Executive Commentary

"In 2025, we demonstrated the exceptional strength of our commercial and R&D capabilities, successfully launching two first and best-in-class medicines and achieving our third FDA approval within the span of approximately one year... Notably, we ended the fourth quarter with 38% growth in Reviforge net revenue and 35% growth in prescription quarter-over-quarter, showing strong demand and momentum heading into 2026."

Michael Metzger, Chief Executive Officer

"We expect the Nictimbo margin contribution, defined as collaboration revenue recorded by Syndax as a percentage of Nictimbo net sales, to be in the 25% to 30% range in the near term and increase longer term as sales grow, while much of the expense base stays largely fixed... With a robust balance sheet, growing revenue from two medicines, and stable expenses, we expect to reach profitability without the need for additional capital."

Keith Goldan, Chief Financial Officer

Strategic Positioning

1. Revuforge: Unlocking Broader AML Penetration

Revuforge’s market expansion is being driven by dual indications—KMT2A and NPM1—supported by rapid payer coverage (97% within four months) and robust prescriber base growth. The label expansion into NPM1, a more prevalent AML mutation, is shifting the patient mix and fueling a trajectory toward higher market share and extended treatment durations. Post-transplant maintenance use, now at 40-45% of eligible KMT2A patients, is stacking incremental volume, with management projecting this could reach 70-80% over time based on physician intent and clinical experience.

2. Nictimbo: Building a Durable Chronic GVHD Franchise

Nictimbo’s early commercial trajectory has outpaced first-year benchmarks set by prior entrants, with persistency and repeat ordering across 90% of transplant centers. The therapy’s unique ability to address both fibrosis and inflammation is driving high satisfaction and long expected durations on therapy, with a meaningful portion of patients projected to remain on drug for years. The commercial model leverages tight account management and co-promotion synergies with partner Insight, supporting durable revenue growth and attractive margin expansion as sales scale.

3. Pipeline and Lifecycle Management: Frontline and Fibrosis Expansion

Syndax’s pipeline execution is focused on two high-impact areas: moving Revuforge into the frontline AML setting and expanding axotilamab, the active in Nictimbo, into idiopathic pulmonary fibrosis (IPF). Ongoing pivotal trials in both fit and unfit AML populations, as well as real-world evidence generation, are designed to solidify Revuforge’s leadership and support further label expansion. For IPF, a Phase 2 trial has completed enrollment, with management targeting a proof-of-concept readout in Q4 2026—a potential gateway to a large, underserved market with significant clinical and commercial upside.

4. Capital Discipline and Path to Profitability

Expense discipline underpins Syndax’s financial strategy, with R&D and SG&A expected to remain flat at $400 million (excluding non-cash stock comp), and a $394 million cash position providing runway to profitability. The company’s ability to scale revenue faster than expenses, particularly as Nictimbo’s fixed-cost base supports operating leverage, is central to management’s confidence in self-funding future growth and clinical expansion.

5. Competitive Positioning and Real-World Differentiation

Despite new entrants in the AML menin inhibitor space, Syndax reports little competitive impact, citing superior efficacy, tolerability, and market access. Real-world combination data and frontline trial leadership position Revuforge as the therapy of choice, with management aiming to dominate the expanding market. Nictimbo’s differentiated mechanism and persistency profile similarly set it apart in chronic GVHD, while the IPF program could further extend the company’s reach into high-value, less-crowded disease areas.

Key Considerations

Syndax’s commercial and development execution in 2025 has set a new baseline for growth, but the company’s long-term trajectory will depend on its ability to sustain momentum across both existing and emerging indications. Investors should weigh the following:

Key Considerations:

  • Duration Extension Potential: Average Revuforge treatment duration is expected to rise from four to six months into the six to twelve-month range as earlier-line and post-transplant use deepens.
  • Market Share Evolution: NPM1 patient uptake is projected to surpass KMT2A as the new indication matures, potentially shifting the revenue mix and expanding total addressable market.
  • Pipeline Readout Impact: Positive Phase 2 IPF data could catalyze a pivotal program and open a new multi-billion dollar opportunity, with subcutaneous formulation development as a key differentiator.
  • Expense and Margin Leverage: Stable operating expenses and rising high-margin collaboration revenue from Nictimbo support a credible path to profitability.

Risks

Key risks include clinical execution in pivotal frontline and IPF trials, potential competitive pressure from new AML entrants, and the challenge of sustaining double-digit sequential growth as market penetration matures. Reimbursement dynamics and real-world tolerability in broader patient populations could also influence uptake and duration. While management projects confidence, the transition from early launch momentum to durable, category-leading franchises will require continued flawless execution and data-driven differentiation.

Forward Outlook

For Q1 2026, Syndax expects:

  • Continued sequential revenue growth in both Revuforge and Nictimbo franchises
  • Stable R&D and SG&A expenses, excluding non-cash stock compensation

For full-year 2026, management maintained guidance:

  • Total operating expenses (excluding stock comp) flat at ~$400 million
  • Profitability achievable without additional capital, supported by revenue scaling and expense discipline

Management highlighted several factors that will drive near-term performance:

  • Further NPM1 and post-transplant penetration for Revuforge
  • Persistency and broader adoption in chronic GVHD for Nictimbo
  • Key data readouts in frontline AML and IPF anticipated in H2 2026

Takeaways

Syndax’s execution in its first commercial year has established strong momentum, with expanding addressable markets, deepening prescriber engagement, and high real-world adoption for both lead assets.

  • Revuforge’s dual-indication ramp is shifting the AML treatment landscape, with label expansion and post-transplant maintenance stacking new volume and supporting longer therapy durations.
  • Nictimbo’s persistency and center penetration underpin durable chronic GVHD growth, with further upside tied to new indications and pipeline lifecycle management.
  • Investors should monitor upcoming frontline and IPF data, as positive readouts could unlock large new markets and reinforce Syndax’s leadership in oncology and fibrosis.

Conclusion

Syndax’s Q4 2025 results reflect a pivotal year of execution, with both commercial and pipeline assets tracking ahead of launch benchmarks and setting the stage for multi-year growth. With robust cash, disciplined spending, and multiple near-term catalysts, the company is well-positioned to extend its leadership across high-value oncology and fibrosis markets.

Industry Read-Through

Syndax’s rapid market penetration for both Revuforge and Nictimbo signals growing physician comfort with novel targeted therapies in hematologic malignancies and chronic immune conditions. The swift payer access and prescriber expansion highlight the importance of robust label differentiation, real-world evidence, and combination-friendly profiles in driving adoption. The pipeline’s focus on frontline and fibrosis indications reflects a broader industry trend toward lifecycle management and multi-indication expansion, underscoring the premium on assets that can both extend duration and broaden addressable populations. Competitors in AML, GVHD, and IPF should note the speed of market capture and the critical role of operational execution in translating clinical innovation into durable commercial leadership.

SNDX Healthcare Pharmaceuticals Oncology Drug Launch Pipeline Chronic GVHD AML