United States Food & Drug Administration Notifies Mesoblast Limited of Available Clinical Data from Phase 3 Trial Appear Sufficient to Support BLA Submission for Remestemcel-L in Children with Steroid-Refractory Acute Graft Versus Host Disease

Mesoblast Limited is an Australia-based is developing a range of late-stage product candidates derived from its proprietary mesenchymal lineage cell therapy technology platforms. The Company’s Remestemcel-L is mesenchymal lineage stromal cell product platform and is in late-stage development for treatment of systemic inflammatory diseases, including Pediatric steroid refractory acute Graft versus Host Disease (SR-aGVHD), acute respiratory distress syndrome (ARDS) and Biologic refractory inflammatory bowel disease. Its Rexlemestrocel-L is mesenchymal lineage precursor cell product platform and is in late-stage development for treatment of advanced chronic heart failure (CHF) and chronic low back pain (CLBP) due to degenerative disc disease. Two products are commercialized in Japan and Europe by the Company’s licensees, and it has a commercial partnership in Europe and China for certain Phase III assets.