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SNDX: Recent FDA Approvals Will Expand Market Opportunity In AML Therapy

Published
24 Mar 25
Updated
18 Dec 25
Views
239
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AnalystConsensusTarget's Fair Value
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1Y
46.2%
7D
-1.4%

Author's Valuation

US$39.3146.5% undervalued intrinsic discount

AnalystConsensusTarget Fair Value

Last Update 18 Dec 25

SNDX: Expanded Leukemia Approval Will Drive Stronger Long Term Commercial Momentum

Analysts have nudged their average price target on Syndax Pharmaceuticals modestly higher, to about $39.31 per share from roughly $39.31, citing strengthened conviction in long term growth and profitability following supportive regulatory developments and recent target increases from multiple covering firms.

Analyst Commentary

Recent target increases and reiterated positive ratings underscore a growing confidence among coverage in Syndax Pharmaceuticals, particularly around its lead asset Revuforj and the companys ability to convert regulatory wins into durable revenue growth.

Bullish Takeaways

  • Bullish analysts view the higher price targets as validation that the current share price underestimates long term revenue potential from Revuforj in relapsed or refractory acute myeloid leukemia.
  • They emphasize that the FDA sNDA approval supports a clearer regulatory pathway, which reduces execution risk and strengthens visibility into near term commercialization milestones.
  • The maintenance of Buy ratings alongside target hikes is seen as a signal that near term volatility following labeling updates has not altered the fundamental growth thesis.
  • Some bullish analysts argue that the recent stock reaction to revised safety language was disproportionate, creating what they see as an attractive entry point relative to updated risk adjusted valuations.

Bearish Takeaways

  • Bearish analysts and more cautious investors focus on the added QTc prolongation Black Box warning, which could limit the pace of adoption despite the high need in the relapsed or refractory AML setting.
  • There is concern that ongoing safety monitoring requirements may add friction to real world prescribing dynamics, potentially delaying the ramp toward consensus revenue estimates.
  • Cautious voices flag that even with increased price targets, the upside is partly contingent on flawless execution in launch strategy and physician education around the benefit risk profile.
  • Some remain wary that any additional safety signals or competitive data in AML could compress valuation multiples, particularly if they challenge current assumptions embedded in models.

What's in the News

  • FDA approved Revuforj (revumenib) for relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation in adult and pediatric patients one year and older who lack satisfactory alternatives, making it the first and only therapy approved for both NPM1 mutated AML and KMT2A translocated acute leukemia (company announcement).
  • The National Comprehensive Cancer Network updated its Clinical Practice Guidelines in Oncology to include revumenib as a category 2A recommendation for relapsed or refractory AML with an NPM1 mutation, and reaffirmed category 2A recommendations for KMT2A rearranged acute leukemia, based on positive AUGMENT 101 trial results published in Blood in 2025 (NCCN Guidelines, Blood 2025).
  • Syndax highlighted multiple Revuforj presentations across the acute leukemia treatment continuum at the 67th American Society of Hematology Annual Meeting in Orlando, underscoring both efficacy data and key safety findings, including differentiation syndrome and QTc prolongation rates from clinical trials (ASH 2025 presentations).
  • The company emphasized continued investment across its pipeline, led by FDA approved Revuforj and Niktimvo, as it advances several clinical trials aimed at expanding treatment options across the cancer care continuum (company pipeline update).

Valuation Changes

  • Fair Value Estimate: Unchanged at approximately $39.31 per share, reflecting stable long term assumptions despite recent regulatory and market developments.
  • Discount Rate: Fell slightly from about 7.37 percent to roughly 7.36 percent, implying a marginally lower perceived risk profile in the updated model.
  • Revenue Growth: Essentially unchanged at approximately 84.22 percent, indicating no material revisions to long term top line expansion expectations.
  • Net Profit Margin: Stable at around 14.42 percent, suggesting no meaningful change in anticipated long term profitability.
  • Future P/E: Edged down slightly from about 43.15x to roughly 43.15x, a negligible move that keeps valuation multiples broadly consistent with prior assumptions.

Key Takeaways

  • Expanding drug adoption, earlier-line usage, and new regulatory approvals are set to drive broader market access and boost long-term revenue growth.
  • Strong late-stage pipeline, fixed costs, and leading positions in precision oncology create operating leverage and sustained momentum for multi-year profitability.
  • The company's heavy reliance on two late-stage drugs and ambitious label expansions amplifies business risks from regulatory, competitive, and market adoption uncertainties.

Catalysts

About Syndax Pharmaceuticals
    A commercial-stage biopharmaceutical company, develops therapies for the treatment of cancer.
What are the underlying business or industry changes driving this perspective?
  • Accelerating adoption of Revuforj and Niktimvo, amid an aging global population and rising cancer incidence, significantly expands Syndax's addressable market and supports sustained long-term revenue growth.
  • Ongoing shift to earlier-line use of Revuforj and increasing post-transplant maintenance therapy materially lengthen average treatment duration and patient retention-both acting as strong multipliers for net revenue and future earnings.
  • Imminent regulatory milestones-including the anticipated sNDA approval and guideline inclusion for Revuforj in relapsed/refractory mutant NPM1 AML-would substantially expand approved patient populations and catalyze a step-function increase in revenues.
  • Fixed operating expense base, together with expanding product sales and cash flow contributions from both franchises, is positioned to drive significant operating leverage, boosting net margins and accelerating the pathway to profitability.
  • Late-stage pipeline advancements (including frontline trials, lifecycle management, and expansion into new indications like IPF for Niktimvo), coupled with strong clinical data and market-leading positions in precision oncology, provide robust long-term growth avenues aligned with surging demand for innovative, targeted therapies-supporting sustained multi-year earnings momentum.

Syndax Pharmaceuticals Earnings and Revenue Growth

Syndax Pharmaceuticals Future Earnings and Revenue Growth

Assumptions

How have these above catalysts been quantified?
  • Analysts are assuming Syndax Pharmaceuticals's revenue will grow by 97.8% annually over the next 3 years.
  • Analysts assume that profit margins will increase from -429.8% today to 7.2% in 3 years time.
  • Analysts expect earnings to reach $43.5 million (and earnings per share of $0.18) by about September 2028, up from $-335.0 million today. However, there is a considerable amount of disagreement amongst the analysts with the most bullish expecting $53.3 million in earnings, and the most bearish expecting $-61.7 million.
  • In order for the above numbers to justify the analysts price target, the company would need to trade at a PE ratio of 90.6x on those 2028 earnings, up from -4.1x today. This future PE is greater than the current PE for the US Biotechs industry at 15.5x.
  • Analysts expect the number of shares outstanding to grow by 0.92% per year for the next 3 years.
  • To value all of this in today's terms, we will use a discount rate of 7.03%, as per the Simply Wall St company report.

Syndax Pharmaceuticals Future Earnings Per Share Growth

Syndax Pharmaceuticals Future Earnings Per Share Growth

Risks

What could happen that would invalidate this narrative?
  • Heavy reliance on the continued commercial success and label expansion of only two late-stage assets (Revuforj and Niktimvo) increases business risk; any clinical, regulatory, or competitive setback for these drugs would have a disproportionate negative impact on future revenue growth and earnings.
  • Despite strong early uptake, high future revenue and margin projections depend on further label expansions (such as anticipated NPM1 approval for Revuforj and expansion of Niktimvo into additional indications); unexpected delays, negative trial data, or increased FDA scrutiny could lengthen timelines or limit addressable populations, negatively impacting both revenue growth and net margins.
  • Intensifying competition from larger, better-resourced oncology and rare disease pharmaceutical companies may erode Syndax's market share, put downward pressure on pricing, and compress both top-line revenue and net margins over the long term.
  • Sustained high R&D and SG&A expenses, combined with uncertainty around the pace and robustness of long-term commercial adoption-especially if market penetration or treatment duration forecasts are overly optimistic-could result in persistent net losses and delayed profitability, directly impacting earnings.
  • Long-term healthcare payer cost pressures, reimbursement risk, and increasing global cost-consciousness in oncology and rare disease markets may restrict pricing power, limit the achievable market opportunity for Syndax's therapies, and compress peak revenues and profitability.

Valuation

How have all the factors above been brought together to estimate a fair value?
  • The analysts have a consensus price target of $36.545 for Syndax Pharmaceuticals based on their expectations of its future earnings growth, profit margins and other risk factors. However, there is a degree of disagreement amongst analysts, with the most bullish reporting a price target of $56.0, and the most bearish reporting a price target of just $19.0.
  • In order for you to agree with the analyst's consensus, you'd need to believe that by 2028, revenues will be $603.4 million, earnings will come to $43.5 million, and it would be trading on a PE ratio of 90.6x, assuming you use a discount rate of 7.0%.
  • Given the current share price of $16.13, the analyst price target of $36.55 is 55.9% higher.
  • We always encourage you to reach your own conclusions though. So sense check these analyst numbers against your own assumptions and expectations based on your understanding of the business and what you believe is probable.

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Disclaimer

AnalystConsensusTarget is a tool utilizing a Large Language Model (LLM) that ingests data on consensus price targets, forecasted revenue and earnings figures, as well as the transcripts of earnings calls to produce qualitative analysis. The narratives produced by AnalystConsensusTarget are general in nature and are based solely on analyst data and publicly-available material published by the respective companies. These scenarios are not indicative of the company's future performance and are exploratory in nature. Simply Wall St has no position in the company(s) mentioned. Simply Wall St may provide the securities issuer or related entities with website advertising services for a fee, on an arm's length basis. These relationships have no impact on the way we conduct our business, the content we host, or how our content is served to users. The price targets and estimates used are consensus data, and do not constitute a recommendation to buy or sell any stock, and they do not take account of your objectives, or your financial situation. Note that AnalystConsensusTarget's analysis may not factor in the latest price-sensitive company announcements or qualitative material.

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