Mesoblast Advances FDA Approvals for Revascor® and Ryoncil®

Mesoblast Limited ( (AU:MSB) ) just unveiled an announcement.

Mesoblast Limited has reported progress with the FDA on the accelerated approval pathway for its product Revascor® in treating ischemic chronic heart failure and a label extension for Ryoncil® in adults with steroid-refractory acute graft versus host disease (SR-aGvHD). The company held a Type B meeting with the FDA to discuss a potential Biologics License Application for Revascor® and plans a meeting in July to discuss a pivotal trial for Ryoncil® in adults. Ryoncil® has been commercially available in the U.S. since March 2025, with significant uptake and coverage expansion, indicating strong market acceptance and potential growth in the cellular medicine industry.

The most recent analyst rating on (AU:MSB) stock is a Buy with a A$1.10 price target. To see the full list of analyst forecasts on Mesoblast Limited stock, see the AU:MSB Stock Forecast page.

More about Mesoblast Limited

Mesoblast Limited is a global leader in developing allogeneic cellular medicines for treating severe and life-threatening inflammatory conditions. The company specializes in mesenchymal lineage cell therapy technology, which releases anti-inflammatory factors to modulate the immune system and reduce inflammation. Mesoblast’s product offerings include RYONCIL® for treating steroid-refractory acute graft versus host disease (SR-aGvHD) and rexlemestrocel-L for heart failure and chronic low back pain. The company is active in markets such as Japan, Europe, and China and holds a robust intellectual property portfolio.

Average Trading Volume: 6,217,748

Technical Sentiment Signal: Buy

Current Market Cap: A$2.38B

See more insights into MSB stock on TipRanks’ Stock Analysis page.