Syndax Pharmaceuticals Nears Critical Regulatory Milestone

Syndax Pharmaceuticals stands at a pivotal juncture, with a significant regulatory decision for its flagship cancer therapy scheduled for late October 2025. The US Food and Drug Administration (FDA) has granted priority review for Revumenib, seeking an expanded label for treating a specific form of acute myeloid leukemia (AML). This development presents a potential catalyst for the company’s stock, which has been navigating a challenging period.

Beyond the FDA’s upcoming verdict, the drug’s commercial prospects received a substantial boost from its recent inclusion in the prestigious NCCN clinical practice guidelines. This endorsement typically facilitates broader market access and accelerates adoption within the US medical community.

Recent quarterly performance underscores the therapy’s growing commercial traction. Syndax reported that Revumenib generated $28.6 million in Q2 revenue, marking a substantial 43% sequential increase from the previous quarter. This growth is particularly notable given that approximately one-third of patients temporarily paused treatment to undergo stem cell transplants. Furthermore, the company benefits from an additional, steady revenue stream through its partnership product, Niktimbo.

Should investors sell immediately? Or is it worth buying Syndax?

Financially, Syndax maintains a robust position to support its ongoing operations and strategic initiatives. The company holds approximately $518 million in liquid assets, providing a considerable runway. This strong financial health is further evidenced by a high liquidity ratio of 5.8 and a minimal debt-to-equity ratio of just 0.03.

The weeks leading to the October 25th FDA decision will be crucial for Syndax. The outcome will determine whether recent regulatory and commercial achievements can successfully rebuild sustained investor confidence or if the biotech firm must continue to contend with market skepticism.