Cell therapy’s outlook brightens as Mesoblast clears ODAC hurdle

Mesoblast is looking ahead to Ryoncil’s Sept. 30 PDUFA date after ODAC panelists shrugged off FDA reviewers’ concerns over assays and backed approval of the stem cell therapy.

Mesoblast Ltd. ( ASX:MSB; NASDAQ:MESO) on Friday announced the Oncologic Drugs Advisory Committee voted 9-1 in favor of Ryoncil remestemcel-L to treat pediatric patients with steroid-refractory acute graft-versus-host disease (GvHD). The therapy comprises allogeneic culture-expanded mesenchymal stem cells...