- Mesoblast (MESO, Financial) advances FDA discussions for Revascor® and Ryoncil® approvals.
- Ryoncil® launches commercially, surpassing expectations with over 20 transplant centers onboarded.
- Ryoncil® achieves extensive insurance coverage, reaching 220 million US lives with impending full Medicaid coverage.
Mesoblast (MESO), a leader in allogeneic cellular medicines for inflammatory diseases, is gaining momentum with the FDA for its products Revascor® and Ryoncil®. In early June, Mesoblast engaged in a Type B meeting with the FDA under the Regenerative Medicines Advanced Therapy (RMAT) designation for Revascor®, focusing on topics essential for a potential Biologics License Application (BLA) filing. The discussions achieved general alignment on chemistry, manufacturing & controls (CMC), potency assays, and the confirmatory trial design, indicating progress towards accelerated approval for treating ischemic chronic heart failure.
For Ryoncil®, which is already FDA-approved for pediatric patients with steroid-refractory acute graft versus host disease (SR-aGvHD), Mesoblast plans to conduct a pivotal trial in adults with the same condition. This trial, to be conducted with the NIH-funded Bone Marrow Transplant Clinical Trials Network, aims to expand Ryoncil's label to adult treatment. The successful commercial launch of Ryoncil® since March 2025 exceeds expectations, with over 20 transplant centers onboarded in the first quarter.
Insurance coverage for Ryoncil® has expanded significantly, now reaching over 220 million US lives through commercial and government payers. To date, 37 out of 51 states provide Medicaid coverage through Orphan Drug Lists or a medical exception process. By July 1, 2025, all states will offer mandatory coverage for 24 million lives, which is crucial for the commercial success of high-cost cell therapies like Ryoncil®.
Mesoblast's Chief Executive, Dr. Silviu Itescu, expressed satisfaction with the FDA interactions and the robust commercial start of Ryoncil®. The company's strategic initiatives in clinical trials and commercial partnerships continue to enhance Mesoblast’s footprint in the biotechnology sector.
