Syndax Pharmaceuticals Q1 Earnings Call Highlights

Key Points

• Over $100 million in combined Q1 net sales — Revuforj $49M and Niktimvo $55M — with both products annualizing near $200M and Revuforj growth driven by NCCN guideline inclusion and an expanded FDA label for NPM1.
• Higher-than-expected stem-cell transplant rates in KMT2A (nearly half of patients) are creating a short-term revenue headwind as patients pause Revuforj, but management expects many to restart therapy and views transplants as supportive of durable long-term growth.
• Pipeline momentum: pivotal frontline menin-inhibitor trials EVOLVE-2 and REVEAL are enrolling and Syndax expects multiple near-term data releases, plus two top-line phase II readouts for axatilimab in chronic GVHD and IPF in Q4.

Syndax Pharmaceuticals NASDAQ: SNDX reported first-quarter 2026 results highlighting more than $100 million in combined net sales for its two commercial products, Revuforj and Niktimvo, as the company emphasized continued uptake, expanding treatment patterns, and multiple upcoming clinical data readouts.

Revuforj sales grow; NPM1 adoption builds after guideline update and label expansion

CEO Michael Metzger said Syndax delivered “over $100 million in combined sales of Revuforj and Niktimvo” in the quarter, which he described as underscoring “robust demand for both medicines” and progress “towards profitability.”

Revuforj net revenue was $49 million in the first quarter, and Metzger said the product grew “by double digits quarter-over-quarter, primarily driven by new NPM1 patients.” The company pointed to momentum following Revuforj’s addition to NCCN guidelines for relapsed/refractory NPM1-mutated AML in September 2025 and the FDA’s expanded label in October 2025.

Chief Commercial Officer Steven Closter said the launch is now “a little over a year” old and that Revuforj net revenue is “annualizing at nearly $200 million.” He said the company added “about 330 new patients” in the first quarter, up about 10% sequentially, driven by new NPM1 patients. Closter added that early indicators suggest “at least 40% of new starts in the first quarter were NPM1 patients,” compared to about 10% prior to the NCCN guideline update.

Closter said the company estimates NPM1 contributed “at least 30% of the $49 million in net revenue” in the quarter when including both new starts and patients continuing therapy from prior months.

Transplant dynamics in KMT2A: short-term headwind, longer-term duration opportunity

Management repeatedly emphasized the role of stem cell transplant in the KMT2A segment and its implications for duration of therapy. Metzger said a recent analysis indicates Revuforj is enabling “nearly half of KMT2A patients to receive a potentially curative stem cell transplant,” up from the company’s prior estimate of 33% and above the 25% transplant rate observed in the clinical trial.

Metzger said the higher transplant rate can create a near-term impact on revenue because patients pause therapy, but he characterized it as “first and foremost a very positive outcome for patients” and said it should support “durable and sustainable growth” as more patients return to therapy post-transplant.

Closter provided additional details from claims-based analyses. He said that around 45% of transplanted KMT2A patients have restarted therapy after pausing treatment for “one to two quarters,” and that the company expects restart rates to rise over time. Long-term, he said Syndax expects “up to 70%-80% of transplanted patients” to return to therapy for “one to two years,” citing clinical trial experience and physician feedback.

During Q&A, Metzger said he did not expect the transplant rate to move “much higher than 50%,” indicating the company may be near a peak in the proportion of KMT2A patients proceeding to transplant. He also said the return-to-therapy timeline appears “more like five, six months, maybe even longer” for some patients, compared with earlier expectations of three to four months, though he added he did not think that would represent the majority of patients.

In response to a question about what investors should look for in upcoming multi-center real-world data, Chief Medical Officer and Head of R&D Nick Botwood said the company expects broad genetic subtype coverage, including NUP98, and continued evidence of “extensive use in combinations of therapy” in the real world. He also flagged transplant rates and post-transplant maintenance as key points of interest, noting physicians are already seeking to use revumenib in maintenance despite it not being promoted for that purpose.

Niktimvo first-quarter net revenue of $55 million; mix shift expected to support growth

Niktimvo net revenue was $55 million in the first quarter, which Metzger said reflected “consistent new patient starts,” partially offset by natural attrition among a large cohort of later-line patients who started during the first quarter of launch last year.

Closter said Niktimvo is “annualizing at over $200 million.” He reported that about “5,000 infusions were administered” in the first quarter and “approximately 300 new patients started,” adding that severe weather affected patient access to infusion drugs during the quarter. He said the company expects indicators of demand to support resumed growth next quarter as it adds “new, less advanced patients.”

On commercial adoption, Closter said that within one year of launch, Niktimvo captured 32% of the “third line plus” market, with most use in fourth line and increasing uptake in third line. He said that of patients who started at launch in the first quarter of last year, “60%-70% remained on therapy” in the first quarter of this year, which he said highlights the potential for longer durations, particularly as the mix shifts toward third-line patients.

Pipeline: frontline menin inhibitor trials advance; axatilimab readouts expected in Q4

Botwood outlined progress in pivotal frontline trials of revumenib, including EVOLVE-2 (revumenib plus venetoclax and azacitidine in newly diagnosed unfit NPM1 or KMT2A AML) and REVEAL (revumenib plus intensive chemotherapy in newly diagnosed fit NPM1 patients, including adults and children 12 and older). He said global site activation and enrollment are underway and that Syndax is “well-positioned to be the first to deliver pivotal frontline data for a menin inhibitor.”

Botwood said EVOLVE-2 has dual primary endpoints of complete remission and overall survival in the NPM1 population, while REVEAL has dual primary endpoints of MRD-negative complete remission and event-free survival. He also described the RAVEN phase II trial testing revumenib plus venetoclax/azacitidine in newly diagnosed KMT2A patients considered fit for intensive chemotherapy, reflecting interest in moving from intensive chemotherapy backbones to “more tolerable” ven-HMA approaches.

The company also previewed a substantial slate of near-term scientific updates. Botwood said at least 15 revumenib abstracts were accepted for ASCO or EHA, with key second-quarter datasets expected to include real-world evidence, post-transplant maintenance data (including an ASCO oral presentation), and updated combination data from multiple trials.

For axatilimab, Botwood said Syndax expects two top-line phase II readouts in the fourth quarter: axatilimab plus ruxolitinib in chronic GVHD (a timeline “pulled in due to faster than anticipated accrual”) and the phase II MAXPIRe idiopathic pulmonary fibrosis (IPF) trial. He said MAXPIRe completed enrollment and “exceeded our original enrollment target of 135 patients.” The trial’s primary endpoint is the annualized rate of decline in forced vital capacity (FVC) measured at 26 weeks, with background anti-fibrotic therapy allowed but not required. Botwood said the company is confident in a 26-week endpoint and plans to use standard models to annualize FVC decline out to 52 weeks.

In discussing NUP98, Botwood said Syndax expects additional data this year and said the company is considering submissions for NCCN guideline inclusion for the subset. He estimated NUP98 rearrangements occur in “up to 5% of AML cases” and described the group as having high unmet need.

Financial update: revenue growth, Niktimvo profit share, and stable expense outlook

Chief Financial Officer Keith Goldan said total revenue was $64.9 million in the quarter, up 224% year-over-year. Revuforj net revenue was $48.9 million, up 144% from the same period last year. Goldan said results came despite “typical first quarter dynamics,” including winter storms that had a transient impact in February and the growing number of KMT2A patients pausing Revuforj for transplant.

For Niktimvo, Goldan said Syndax recorded $15.9 million in collaboration revenue, representing its 50% share of net commercial profit. He said that figure was 29% of Niktimvo product revenue reported by Incyte, within the company’s guided 25% to 30% range.

Goldan reiterated 2026 guidance for combined R&D plus SG&A expenses of approximately $400 million, excluding $50 million in estimated non-cash stock-based compensation. He said Syndax ended the quarter with $352.1 million in cash, cash equivalents, and marketable securities as of March 31, 2026.

On gross-to-net dynamics, Goldan said Syndax continues to expect gross-to-net to settle in the 20% to 25% range and cited typical first-quarter seasonality related to commercial deductible resets and Medicare Part D coverage dynamics.

Management said it does not provide revenue guidance. Asked about access, Closter said Revuforj formulary coverage stands at 97% of covered lives, and that step edits exist in “literally three plans” and apply only to the 270 mg dose, representing less than 1% of covered lives. He said the step was “practically ineffective” and that, to date, “there’s not one patient that has had to walk through a step for Revuforj.”

Looking ahead, Metzger reiterated expectations for continued growth driven by NPM1 uptake and evolving transplant and maintenance dynamics in KMT2A, alongside potential fourth-quarter readouts in chronic GVHD and IPF that the company said could open additional markets.

About Syndax Pharmaceuticals NASDAQ: SNDX

Syndax Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for the treatment of cancer. Headquartered in Waltham, Massachusetts, the company focuses on small-molecule inhibitors that target key epigenetic and protein interaction pathways. Syndax's research platform aims to enhance the effectiveness of existing therapies and address high unmet medical needs in oncology.

The company's lead investigational candidate, entinostat, is a selective class I histone deacetylase (HDAC) inhibitor being evaluated for multiple solid tumor and hematologic indications.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.