Mesoblast to File Biologics License Application for Ryoncil® FDA Approval Next Week

Company Overview - Mesoblast is a global leader in developing allogeneic cellular medicines for inflammatory diseases, with a strong intellectual property portfolio extending to at least 2041 in major markets [1][6] - The company has proprietary manufacturing processes that produce industrial-scale, cryopreserved, off-the-shelf cellular medicines, making these therapies readily available to patients worldwide [1] Product Development - Mesoblast is preparing to file its Biologics License Application (BLA) for Ryoncil® (remestemcel-L) to treat children with steroid-refractory acute graft versus host disease (SR-aGVHD) with the FDA [5] - The company is developing product candidates based on its remestemcel-L and rexlemestrocel-L technology platforms for various indications, including inflammatory diseases and chronic conditions [7] - Two products have already been commercialized in Japan and Europe by Mesoblast's licensees, and the company has established commercial partnerships in Europe and China for certain Phase 3 assets [7] Market Presence - Mesoblast operates in Australia, the United States, and Singapore, and is listed on the Australian Securities Exchange (ASX: MSB) and Nasdaq (NASDAQ: MESO) [2]