Early success in GvHD sets up NDA for Kadmon’s lead

With its lead clinical candidate meeting the primary endpoint at an interim analysis of a pivotal trial for third-line chronic graft-versus-host disease, Kadmon plans to submit an NDA next year for KD025 following next half's primary analysis.

On a conference call Monday, Kadmon Holdings Inc. (NYSE:KDMN) President and CEO Harlan Waksal said the ρ-associated coiled-coil containing protein kinase 2 (ROCK2) inhibitor cleared a hurdle “much higher than the primary analysis” by meeting at this stage...