Mesoblast is a commercial-stage biotechnology company that develops and sells allogeneic (off-the-shelf) cell therapies for severe inflammatory diseases. Its products are based on mesenchymal lineage cells derived from bone marrow donors, which suppress damaging immune responses when introduced to areas of severe inflammation. Cells are manufactured by Lonza under a long-term outsourcing agreement, cryopreserved, and distributed via specialty cold-chain logistics — because a single donor yields thousands of doses, no patient-specific manufacturing is required. Mesoblast's lead commercial product is Ryoncil, FDA-approved in December 2024 for steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients. Ryoncil is the only approved therapy for this population and carries orphan-drug and biologic exclusivity through 2036, with composition-of-matter patents through at least 2044. Ryoncil is sold to roughly 45 U.S. transplant centers at a wholesale cost of approximately $194,000 per infusion, with a full treatment course of 8 infusions totaling roughly $1.55M per patient. Beyond Ryoncil, Mesoblast is developing Revascor for end-stage ischemic heart failure, targeting FDA accelerated approval by end of 2025, and rexlemestrocel-L for chronic low back pain, with a Phase 3 trial currently enrolling. Mesoblast also receives royalties from licensees, including JCR Pharmaceuticals in Japan and Takeda in Europe, who market MSC-based products under license. For large-distribution indications like CLBP, Mesoblast plans to partner commercially rather than build its own sales force.
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