Appendix 4C Quarterly Activity Report for Quarter Ended June 30, 2024
Mesoblast (MESO) GlobeNewswire News Room·2024-07-31 01:13
"Our BLA resubmission for approval of Ryoncil® (remestemcel-L) in the treatment of children with acute graft versus host disease (SR-aGVHD) was accepted as a complete response, we received feedback from FDA on the potential accelerated approval pathway for Revascor® (rexlemestrocel-L) in end-stage heart failure patients, and our confirmatory Phase 3 trial in inflammatory back pain is actively enrolling with a primary endpoint of pain reduction aligned with FDA." FDA informed Mesoblast at the end of March 20 ...