05:59 PM EDT, 08/14/2024 (MT Newswires) -- Incyte ( INCY ) and Syndax Pharmaceuticals ( SNDX ) said late Wednesday that the US Food and Drug Administration has approved niktimvo to treat chronic graft-versus-host disease.

The treatment is for patients who have endured failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kilograms or 88.2 pounds.

Chronic GVHD occurs when donated stem cells in a transfer initiate an immune response and attack the transplant recipient's organs.

The FDA approval follows data from a global study evaluating the safety and efficacy of niktimvo in 241 adult and pediatric patients.

Shares of Syndax were up 3.8% in after-hours activity.