Mesoblast has completed patient recruitment for its pivotal Phase 3 trial testing rexlemestrocel-L, a cell therapy for chronic low back pain linked to degenerative disc disease. The trial involves 300 patients receiving either the therapy or placebo, aiming to confirm earlier positive results showing pain reduction and decreased opioid use. Top-line results are expected by mid-2027, with plans for FDA approval filing in Q3 2027. This therapy could address a major unmet need, potentially generating over $10 billion in peak revenue.
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...
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...
