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,... Read more...