FDA Approvals
Syndax Scores Two FDA Approvals in 2024
Fierce Pharma
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January 2, 2025
Small biotech Syndax gained two FDA approvals in 2024 for Niktimvo (chronic graft-versus-host disease) and Revuforj (lysine methyltransferase 2A leukemia), showcasing the success of smaller companies.
In 2024, Syndax, a relatively small Massachusetts biotech with only 107 employees at the start of 2023, achieved two significant FDA approvals. This is noteworthy because most multiple approvals went to large pharmaceutical companies. Their first approval, in August, was for Niktimvo, in partnership with Incyte, to treat chronic graft-versus-host disease. Then, in November, they received approval for Revuforj, the first menin inhibitor for a specific type of leukemia. These approvals highlight the increasing capacity of smaller biotech firms to compete with industry giants and bring innovative treatments to market.