Mesoblast Secures Seven-Year FDA Orphan-Drug Exclusivity for Ryoncil®

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

Mesoblast Limited has received a seven-year orphan-drug exclusive approval from the FDA for its product Ryoncil® (remestemcel-L), used in treating steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients. This exclusivity prevents the approval of similar mesenchymal stromal or stem cell products for the same indication during this period. Additionally, Mesoblast holds biologic exclusivity until December 2036, protecting against biosimilar market entry. These exclusivities, combined with Mesoblast’s strong intellectual property portfolio, provide a significant commercial barrier to competitors, reinforcing the company’s market position and offering long-term protection in major markets.

The most recent analyst rating on (AU:MSB) stock is a Buy with a A$3.40 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 severe and life-threatening inflammatory conditions. The company specializes in therapies using its proprietary mesenchymal lineage cell therapy technology platform, which targets severe inflammation by releasing anti-inflammatory factors. Mesoblast’s flagship product, Ryoncil® (remestemcel-L), is the first FDA-approved mesenchymal stromal cell therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients. The company is also developing additional cell therapies for other inflammatory diseases and has established commercial partnerships in Japan, Europe, and China.

Average Trading Volume: 6,858,041

Technical Sentiment Signal: Buy

Current Market Cap: A$2.2B

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