Mesoblast seeks FDA meeting for accelerated approval of Revascor in treating heart failure

From GlobeNewswire: 2025-04-02 19:15:00

Mesoblast plans to meet with the FDA to discuss accelerated approval for Revascor in treating patients with heart failure and inflammation. The meeting will focus on feedback on chemistry, manufacturing, and design for a confirmatory trial. Mesoblast is a leader in allogeneic cellular medicines for inflammatory diseases and has received guidance from the FDA on accelerated approval based on clinical trials. The company’s RYONCIL is the first FDA-approved mesenchymal stromal cell therapy. Mesoblast is committed to developing cell therapies for various inflammatory conditions and has a strong global intellectual property portfolio. The company’s proprietary manufacturing processes yield off-the-shelf cellular medicines planned to be available worldwide. Mesoblast has locations in Australia, the US, and Singapore and is listed on the ASX and Nasdaq. For more information, visit www.mesoblast.com.



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