Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD

Core Insights - Mesoblast is making progress with the FDA regarding the accelerated approval pathway for Revascor and label extension for Ryoncil [1][2][3] Group 1: FDA Interactions and Approvals - A Type B meeting was held with the FDA to discuss the potential filing for a Biologics License Application (BLA) for Revascor, with alignment on key components [2] - An upcoming meeting with the FDA is scheduled to discuss a pivotal trial of Ryoncil in adults with steroid refractory acute graft versus host disease (SR-aGvHD) [3] Group 2: Commercial Launch and Market Coverage - Ryoncil became commercially available in the U.S. on March 28, 2025, with over 20 transplant centers onboarded by the end of the quarter, exceeding expectations [4] - The company has expanded Ryoncil's coverage to over 220 million U.S. lives insured, with 37 of 51 states providing Medicaid coverage [4] Group 3: Company Overview and Future Developments - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory conditions, utilizing proprietary mesenchymal lineage cell therapy technology [6][8] - The company is committed to developing additional cell therapies for various indications, including inflammatory bowel disease and chronic low back pain [8]