FDA ApprovalRyoncil gains approval in the US for pediatric steroid refractory acute graft vs host disease, marking a significant milestone for Mesoblast and validating FDA's supportive stance on cell therapy.
Market OpportunityRyoncil is positioned for a market opportunity of approximately $500 million due to the high pricing range similar to CAR-T and gene therapy, driven by the high unmet need in pediatric SR-aGvHD.
Pipeline PotentialSignificant potential for Mesoblast in its late-stage pipeline, including heart failure (HF), with potentially two near-term filings, as well as the ongoing P3 in chronic lower back pain (CLBP).