Mesoblast receives 7 years of exclusive approval from US FDA for Ryoncil, positive.

From Yahoo Finance: 2025-06-29 13:28:00

Mesoblast Limited (NASDAQ: MESO) received 7 years of orphan-drug exclusive approval from the US FDA for Ryoncil® to treat steroid-refractory acute graft versus host disease in pediatric patients 2 months and older.

Mesoblast (MESO) also has biologic exclusivity until December 2036, with a strong US intellectual property position on MSC composition of matter, manufacturing, and indications, including SR-aGvHD, providing a barrier to entry for competitors until 2044.

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Read more: Mesoblast (MESO) Gets 7 Years of Orphan-drug Exclusive Approval from US FDA for Ryoncil