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Mesoblast Limited (MESO)’s Ryoncil® Gains U.S.-Origin Status, Avoids Import Tariffs
Yahoo Finance· 2025-10-01 17:46
Group 1 - Mesoblast Limited (NASDAQ:MESO) is a leader in developing allogeneic, off-the-shelf cellular medicines for inflammatory diseases, targeting severe conditions by modulating immune responses and promoting tissue repair [2] - The company's lead product, Ryoncil® (remestemcel-L), is the first FDA-approved allogeneic mesenchymal stromal cell therapy for pediatric patients with steroid-refractory acute graft versus host disease (SR-aGvHD) [2] - In late September 2025, Mesoblast reaffirmed that all its cell therapy products, including Ryoncil®, are manufactured from U.S. donors, which exempts them from pharmaceutical import tariffs, providing a commercial advantage [3] Group 2 - Mesoblast is advancing the commercial launch of Ryoncil® and progressing regulatory pathways for other therapies, including a Biologic License Application for Revascor® aimed at treating ischemic heart failure, which is under FDA review [4] - The company is also expanding the development of rexlemestrocel-L for chronic conditions such as heart failure and low back pain [4]