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Syndax Pharmaceuticals, Inc.

Syndax Pharmaceuticals, Inc. Q4 FY2025 earnings call

February 26, 2026 · fiscal period ended 2025-12

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Summary

Generated 2026-02-26

Management highlights

• Michael Metzger noted 2025 was transformational with two first and best-in-class medicines launched and third FDA approval. Revuforge had strong 2025 results and Q4 growth driven by KMT2A and NPM1. Nictimbo had Q4 growth. • Steve Kloster discussed Revuforge's Q4 performance, growth drivers including NPM1 uptake, transplant rate in KMT2A, and combination use. Nictimbo's growth drivers include adoption in later lines, long therapy durations, and robust prescriber base. • Nick Botwood talked about pipeline progress, including Revumenib's frontline trials and axotilamab's IPF trial progress. • Keith Goldan highlighted 2025 financials, Q4 Revuforge growth, Nictimbo collaboration revenue, and 2026 expense guidance with stable balance sheet.

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Segment performance

In 2025, Revuforge generated $125 million in net revenue. Fourth quarter had 38% growth in Revuforge net revenue and 35% growth in prescriptions. Nictimbo had 22% quarter-over-quarter net revenue increase in Q4, with 2025 net revenue reaching $152 million in the first 11 months of launch. Syndax revenue totaled $172 million in 2025.

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Guidance

• 2026 expenses expected to be stable at ~$400 million excluding non-cash stock comp. • Expect continued growth in Revuforge with multiple drivers. • Nictimbo expected to have robust sales growth due to high unmet need and long therapy durations. • Revumenib's frontline trials ongoing with potential for pivotal data. • Axotilamab's IPF trial expected to have top-line data in Q4 2026.

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Q&A highlights

Q: Last month at J.P. Morgan, usage in KMT2A maintenance post-transplant was 30%-40%, now 40-45%. What factors driving increase?

A: Growth in KMT2A, more patients going to transplant and coming back for maintenance, physicians wanting to do this.

Q: About 30% of patients from NPM1 early data, what steady state? And on IPF trial, what looking for?

A: Expect NPM1 percentage to grow meaningfully, likely 50-50 or more as NPM1 population is larger. For IPF trial, looking for statistical significance and clinical relevance against historical controls, primary endpoint FVC annualized rate of decline at 26 weeks, benchmarking against historical data.

Q: Follow-up on IPF trial, if positive, fastest path to pivotal and next indication?

A: Would be expeditious in designing next trial, planning phase three with sub-Q regimen, intending to start phase three soon after phase two if positive. Prioritize based on clinical need and data.

Q: As capture patients earlier, contribution of components to 6-12 month duration?

A: Combination use growing, allowing earlier treatment and longer durations, monotherapy also important, combinations key in frontline.

Q: Maintenance therapy dose comfort and Rebiforge in newly diagnosed fit KMT2A?

A: Physicians comfortable with maintenance dose, standard dose is 16270, ongoing trial to optimize. For fit KMT2A, Raven trial is innovative combining with Veneza to reduce morbidity, data dependent for label.

Q: Nictimbo sequential growth, anecdotes and future?

A: Nictimbo off to great start, serving unmet need, priority accounts, good dynamics in new patients and persistency, expect steady growth.

Q: Biological similarities/dissimilarities between IPF and chronic GVHD?

A: Both associated with inflammation and fibrosis, increased circulating monocytes and macrophages, GVHD pulmonary manifestations more obstructive, IPF more restrictive, but similar underlying biology.

Q: IPF trial dose response and phase three?

A: Lower dose 0.3 mg per kg well-tolerated and effective in GVHD, phase three planned with standard 52-week endpoint, sub-Q regimen possible.

Q: Combo agents, average duration of therapy in M1 vs KMT2A?

A: Most combo use with Veneza, 2025 REB average duration 4-6 months, expected to extend to 6-12 months.

Q: Post-transplant maintenance steady state percentage and IPF competitive landscape?

A: Expect maintenance percentage to meaningfully increase, possibly 70-80%, IPF has high unmet need, axotilamab's unique mechanism targeting macrophages, sub-Q regimen competitive.

Q: Real-world dynamics of combo use and percentages?

A: Combo use growing, 40% expected to increase, real-world data from trials will drive increased use due to better outcomes.

Q: NPM1 growth bolus and impact of competitor?

A: NPM1 growth is a ramp, not bolus, feel no significant impact from competitor, have superior product profile and execution.

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Transcript

February 26, 2026

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