- Kadmon Holdings (NASDAQ:KDMN) is up 7% premarket on light volume following its announcement that the FDA has designated KD025 a Breakthrough Therapy for the treatment of patients with chronic graft-versus-host disease (cGVHD) who have failed to respond to two or more prior lines of systemic therapy.
- A Phase 2 study is currently recruiting patients.
- Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
- Small molecule KD025 inhibits an pro-inflammatory enzyme called rho-associated coiled-coil kinase 2 (ROCK2). Inhibiting the enzyme down-regulates the ability of the immune system's T cells to secrete IL-21 and IL-17, thereby dampening the immune response.
- Previously: Kadmon to launch registration study for KD025 in GvHD; shares up 3% (April 10)