Syndax Pharmaceuticals (SNDX) Is Up 26.1% After FDA Priority Review for Revuforj and Revenue Surge

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  • Syndax Pharmaceuticals recently reported second quarter 2025 results, showing revenues of US$37.96 million, up sharply from US$3.5 million a year earlier, and a net loss of US$71.85 million, compared with US$68.06 million previously.
  • Alongside this earnings release, the company announced that the FDA has granted Priority Review for Revuforj’s supplemental New Drug Application in relapsed or refractory mutant NPM1 acute myeloid leukemia, highlighting expanding opportunities in its targeted therapies portfolio.
  • We'll examine how Revuforj’s FDA Priority Review could reshape Syndax Pharmaceuticals’ investment narrative by accelerating potential revenue expansion.

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Syndax Pharmaceuticals Investment Narrative Recap

To be a shareholder in Syndax Pharmaceuticals, you need to believe in the company’s capacity to translate continued regulatory progress into meaningful, durable commercial growth, especially as it relies on expanding indications for its lead therapies, Revuforj and Niktimvo. The recent FDA Priority Review for Revuforj in relapsed or refractory mutant NPM1 acute myeloid leukemia represents a significant short-term catalyst by potentially accelerating its label expansion, although the risk of setbacks in regulatory or clinical outcomes remains firmly in view.

The June 24, 2025 FDA Priority Review announcement is directly relevant here, as it set the stage for this quarter's sharp 983% year-on-year revenue jump; rapid progress toward broader approval for Revuforj is integral to Synadix’s growth thesis and current investor enthusiasm. However, the company’s continued large net losses highlight the ongoing challenge of high investment in commercialization and R&D alongside advancing regulatory milestones.

By contrast, investors should be aware that any unexpected delay or negative regulatory outcome on Revuforj’s expanded use could...

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

Syndax Pharmaceuticals is projected to reach $540.8 million in revenue and $17.3 million in earnings by 2028. This outlook is based on an annual revenue growth rate of 90.7% and an earnings increase of $352.3 million from current earnings of -$335.0 million.

Uncover how Syndax Pharmaceuticals' forecasts yield a $36.36 fair value, a 131% upside to its current price.

Exploring Other Perspectives

SNDX Community Fair Values as at Aug 2025

Four fair value estimates from the Simply Wall St Community place Syndax Pharmaceuticals anywhere between US$9.64 and US$305.94 per share. Rapid regulatory milestones for Revuforj could alter the company’s revenue potential, but many market participants still see considerable uncertainty in the path ahead.

Explore 4 other fair value estimates on Syndax Pharmaceuticals - why the stock might be a potential multi-bagger!

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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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