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The earnings call summary highlights strong financial performance, product development, and market strategy, with optimistic guidance and shareholder return plans. The Q&A section provides additional positive insights, such as excellent payer access and a consistent safety profile for Revuforj. The strategic plan indicates significant growth opportunities, including market expansion and profitability outlook. Considering the company's strong market position, upcoming product approvals, and positive financial health, the stock is likely to see a positive movement in the short term.
Total Revenue $45.9 million for the third quarter, representing strong 21% growth over the prior quarter. The growth is attributed to the launch metrics for Revuforj and Niktimvo, which are addressing major unmet patient needs.
Net Revenue for Revuforj $32 million in the third quarter, up 12% from the prior quarter. Growth occurred despite approximately 1/3 of patients temporarily pausing treatment to receive a stem cell transplant. Indicators of demand remain strong with approximately 25% growth in total prescriptions and new patient starts.
Net Revenue for Niktimvo $45.8 million in the third quarter, a robust 27% increase over the prior quarter. The growth is attributed to rapid and durable improvements observed in patients and increasing adoption among healthcare providers.
Collaboration Revenue from Niktimvo $13.9 million for the third quarter. Niktimvo continues to be a positive cash flow contributor to Syndax, with a margin contribution expected to grow as sales increase.
Cash Position $456 million in cash, equivalents, and short- and long-term investments as of September 30, 2025. The company expects to reach profitability with current funds on hand.
Revuforj: Generated $32 million in net revenue in Q3 2025, up 12% from the prior quarter. It has become the standard of care for relapsed/refractory KMT2A and is being used earlier in treatment paradigms. FDA approval for relapsed/refractory NPM1 mutated AML was received, tripling the addressable patient population. Physicians are enthusiastic about its efficacy, with unmatched data including a 50% overall response rate and 2-year median overall survival among responders.
Niktimvo: Generated $45.8 million in net revenue in Q3 2025, a 27% increase from the prior quarter. It is annualizing at nearly $200 million and is profitable to Syndax. Physicians report rapid and durable improvements in chronic GVHD patients, with 80% of patients remaining on therapy since Q1 2025.
Market Expansion for Revuforj: FDA approval for relapsed/refractory NPM1 mutated AML expanded the addressable U.S. population from 2,000 to 6,500 patients annually, representing a $2 billion market opportunity. Expansion into the frontline setting is underway, targeting a combined market opportunity exceeding $10 billion.
Market Expansion for Niktimvo: Niktimvo is addressing a $2 billion market opportunity in chronic GVHD, with significant room for growth as it gains adoption in earlier lines of therapy.
Revenue Growth: Total revenue for Q3 2025 was $45.9 million, a 21% increase over the prior quarter. Revuforj and Niktimvo are driving growth, with Revuforj showing 25% growth in prescriptions and new patient starts.
Operational Efficiency: Syndax maintains a strong financial position with $456 million in cash and investments. Operating expenses are stable, and the company is on track to achieve profitability with current funds.
Strategic Priorities: Focus on expanding Revuforj and Niktimvo into the frontline setting, which could unlock a combined market opportunity exceeding $10 billion. The company is also advancing pivotal trials for both products to solidify leadership in their respective markets.
Regulatory and Reimbursement Challenges: The company faces potential challenges in maintaining favorable gross-to-net adjustments due to higher proportions of 340B business and increased exposure to Medicare and Medicaid, which mandate statutory discounts. This could impact revenue growth.
Supply Chain and Inventory Management: There was a slight drawdown of inventory in the channel, which could indicate potential risks in maintaining consistent supply levels.
Market Competition: While the company has a first-mover advantage in menin inhibitors, competition from other companies entering the market could erode market share over time.
Strategic Execution Risks: The company’s ability to expand into the frontline setting and execute pivotal trials like EVOLVE-2 and REVEAL is critical. Any delays or failures in these trials could significantly impact growth projections.
Economic and Financial Risks: The company’s profitability is contingent on maintaining stable operating expenses and achieving projected revenue growth. Any unexpected increases in costs or slower-than-expected revenue growth could delay profitability.
Post-Transplant Maintenance Adoption: The adoption of Revuforj in the post-transplant maintenance setting is still building. If adoption rates do not meet expectations, it could impact long-term revenue growth.
Physician and Patient Adoption: The success of new indications like NPM1 depends on rapid physician and patient adoption. Any delays in awareness or trust-building could slow market penetration.
Revenue Growth: Sales growth is expected to accelerate in the coming quarters due to the approval of Revuforj for NPM1 and increasing average duration of therapy in KMT2A patients.
Market Opportunity: The expansion of Revuforj into NPM1 increases the annual total addressable U.S. population from 2,000 to 6,500 incident patients, representing a $2 billion-plus market opportunity.
Frontline Expansion: Strategic priorities include expanding Revuforj and Niktimvo into the frontline setting, unlocking a combined market opportunity exceeding $10 billion.
Clinical Trials: Enrollment is underway for the pivotal EVOLVE-2 trial for Revuforj in the frontline setting, and two frontline trials for Niktimvo are ongoing in combination with standard of care therapies.
Profitability: Syndax expects to reach profitability with current funds on hand, supported by increasing cash flow contributions from Revuforj and Niktimvo and a stable expense base.
Product Differentiation: Revuforj is positioned as the first and only menin inhibitor FDA-approved for multiple acute leukemia subtypes, with unmatched efficacy data in relapsed/refractory NPM1 and KMT2A patients.
Long-Term Therapy: The average duration of therapy for KMT2A patients is expected to increase to 6-12 months in 2026 as treatment patterns mature.
Niktimvo Growth: Niktimvo is expected to continue robust growth, with patients likely to remain on therapy for years due to the chronic nature of GVHD and high response rates.
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The earnings call summary highlights strong financial performance, product development, and market strategy, with optimistic guidance and shareholder return plans. The Q&A section provides additional positive insights, such as excellent payer access and a consistent safety profile for Revuforj. The strategic plan indicates significant growth opportunities, including market expansion and profitability outlook. Considering the company's strong market position, upcoming product approvals, and positive financial health, the stock is likely to see a positive movement in the short term.
The earnings call highlights strong revenue growth for both Revuforj and Niktimvo, with positive physician and patient feedback. The company expects profitability with existing resources and stable expenses. The Q&A section provides confidence in FDA approval and market expansion, particularly with the NPM1 label expansion. Although management avoided specific guidance, the overall sentiment is positive with strong financial performance and optimistic future outlooks.
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