Mesoblast Maintains Momentum With FDA on Accelerated

From GlobeNewswire: 2025-06-11 21:24:00

Mesoblast provided an update on the FDA’s accelerated approval pathway for Revascor® in treating patients with ischemic chronic heart failure and inflammation, as well as label extension for Ryoncil® in adults with SR-aGvHD. Discussions with FDA on filing for a BLA for Revascor® are underway, while a pivotal trial for Ryoncil® in adults is scheduled for July. Ryoncil® has seen a successful commercial launch in the US, with coverage expanding to over 220 million lives insured. Mesoblast CEO Dr. Silviu Itescu expressed optimism about the company’s progress and upcoming sales update in the quarterly report.



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