FDA Approval of Two First-in-Class Medicines
In 2024, Syndax received FDA approval for Revuforj, a menin inhibitor for relapsed/refractory acute leukemia, and Niktimvo for chronic Graft versus Host Disease, marking the company's entry into product revenue with $7.7 million from Revuforj in the initial five weeks of launch.
Strong Financial Position and Partnerships
Syndax strengthened its balance sheet with $350 million from a deal with Royalty Pharma, positioning the company to fund operations through profitability. The company also launched Niktimvo in partnership with Incyte.
Positive Clinical Data for Revuforj
Clinical trials showed Revuforj's effectiveness in treating acute leukemias, with potential for label expansion to include mutant NPM1 AML, representing a $2 billion market opportunity.
Encouraging Commercial Launch of Revuforj
Revuforj generated $7.7 million in net revenue in a partial quarter, with strong early patient demand and positive feedback on product profile and accessibility.
Niktimvo Potential Market Opportunity
Niktimvo targets a $1.5 billion to $2 billion market for third-line or later chronic GVHD treatment in the US, with potential for further expansion into earlier lines of treatment and other diseases.