Decision On Kadmon's Belumosudil US Application In Chronic GVHD Pushed Back By Three Months

The FDA has extended the review period for Kadmon Holdings Inc's (NASDAQ: KDMN) marketing application seeking approval for belumosudil to treat chronic graft-versus-host disease (cGVHD).

• The goal date for the Priority Review of belumosudil has been extended to August 30, from May 30.
• The FDA extended the date to allow time to review Kadmon's additional information in response to a recent FDA information request.
• In November last year, the FDA accepted and granted Priority Review for belumosudil application to treat patients with cGVHD.
• Belumosudil (KD025) is a selective oral inhibitor of Rho-associated coiled-coil kinase 2, a signaling pathway that modulates inflammatory response and pro-fibrotic processes.
• Price Action: KDMN shares are trading 8.33% lower at $4.51 in premarket trading on the last check Thursday.