Incyte, Syndax announce FDA approval of Niktimvo

Incyte (INCY) and Syndax Pharmaceuticals (SNDX) announced that the U.S. FDA has approved Niktimvo, an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 88.2 lbs. In the United States, Niktimvo will be co-commercialized by Incyte and Syndax Pharmaceuticals. Incyte has exclusive commercialization rights for Niktimvo outside of the U.S. To facilitate patient dosing and limit product waste, following the FDA’s approval of Niktimvo (as a 50mg vial), Incyte and Syndax will seek approval to launch two smaller vial sizes. Following FDA approval of the new vial sizes, the companies anticipate launching Niktimvo in the U.S., no later than early first quarter 2025.