Mesoblast has reached its goal of treating 300 patients in its pivotal Phase 3 trial of rexlemestrocel-L, a cell therapy for chronic low back pain caused by degenerative disc disease. This trial aims to confirm pain reduction benefits seen in earlier studies, with results expected by mid-2027. The therapy has FDA RMAT designation, which could speed up approval. Success could lead to a major new treatment option for millions suffering from chronic low back pain and reduce opioid use.
Mesoblast has transitioned into a commercial-stage company, anchored by its FDA-approved product Ryoncil, which treats pediatric steroid-refractory acute graft-versus-host disease (SR-aGvHD). The approval and established manufacturing and reimburseme...
Mesoblast Limited reported net revenue of $36 million for the fourth quarter and $115 million for the full fiscal year ending June 30, 2026, driven by strong sales of its FDA-approved cellular therapy Ryoncil® for pediatric steroid-refractory acute g...
