Will FDA Approval of Revuforj for AML Transform Syndax Pharmaceuticals' (SNDX) Investment Narrative?

• In late October 2025, Syndax Pharmaceuticals announced that the U.S. FDA approved Revuforj® (revumenib) for the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation in adult and pediatric patients as young as one year old who lack satisfactory alternative treatment options.
• This regulatory milestone establishes Revuforj as the first and only FDA-approved therapy for both NPM1-mutated and KMT2A-translocated relapsed or refractory AML, potentially broadening its clinical reach and significance within precision oncology.
• With Revuforj's new FDA approval expanding its indicated patient population, we'll now explore how this milestone impacts Syndax's investment narrative.

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Syndax Pharmaceuticals Investment Narrative Recap

To be a Syndax Pharmaceuticals shareholder right now, you primarily need to believe that the company’s precision oncology therapies, especially Revuforj and Niktimvo, can deliver strong and sustained commercial adoption. The recent FDA approval of Revuforj for NPM1-mutated AML addresses the most anticipated short-term catalyst by expanding its treatable patient base, but it also underscores the company's ongoing reliance on just two late-stage assets as a concentrated risk.

One related announcement worth spotlighting is the National Comprehensive Cancer Network’s (NCCN) recent category 2A guideline upgrade for revumenib in R/R AML with an NPM1 mutation. This peer-reviewed endorsement could accelerate clinical adoption and compound the revenue impact of the new FDA label, strengthening the company's short-term outlook while reinforcing expectations tied to expanded patient access.

However, just as potential for new patient growth rises, investors should also follow what happens if competitive pressure or regulatory setbacks affect these key drugs...

Read the full narrative on Syndax Pharmaceuticals (it's free!)

Syndax Pharmaceuticals' narrative projects $603.4 million revenue and $43.5 million earnings by 2028. This requires 97.8% yearly revenue growth and a $378.5 million earnings increase from -$335.0 million today.

Uncover how Syndax Pharmaceuticals' forecasts yield a $36.55 fair value, a 167% upside to its current price.

Exploring Other Perspectives

Six individual investors in the Simply Wall St Community see Syndax’s fair value ranging widely from US$9.64 up to US$209.92 per share. While many focus on opportunities from a broadened Revuforj label, others weigh the outsized risks tied to reliance on just two commercial drugs, making it critical to consider multiple viewpoints.

Explore 6 other fair value estimates on Syndax Pharmaceuticals - why the stock might be a potential multi-bagger!

Build Your Own Syndax Pharmaceuticals Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Syndax Pharmaceuticals research is our analysis highlighting 2 key rewards that could impact your investment decision.
• Our free Syndax Pharmaceuticals research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Syndax Pharmaceuticals' overall financial health at a glance.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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