FDA green light for Rezurock in chronic graft-versus-host disease

Shares of USA-based Kadmon Holdings (Nasdaq: KDMN) shot up more than 20% to $4.28 on Friday, after the company revealed its pharma unit had received its first regulatory approval, for Rezurock (belumosudil).

The US Food and Drug Administration approved Kadmon Pharmaceuticals’ New Drug Application (NDA) for Rezurock, a kinase inhibitor, for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.

Efficacy was evaluated in KD025-213 (NCT03640481), a randomized, open-label, multicenter dose-ranging trial that included 65 patients with chronic GVHD who were treated with belumosudil 200mg taken orally once daily.