Mesoblast (ASX:MSB) Receives 7-Year FDA Orphan Drug Approval for Ryoncil™
Regulatory Approval
Mesoblast has received seven years of orphan-drug exclusive approval from the FDA for Ryoncil™ (remestemcel-L), used to treat steroid-refractory acute graft versus host disease in pediatric patients aged two months and older. This exclusivity prevents the FDA from approving another MSC product for this indication until 2032.
Intellectual Property
Additionally, Mesoblast holds biologic exclusivity until December 2036, blocking biosimilars. The company’s robust IP portfolio, with over 1,000 patents and applications, offers protection against competitors until at least 2044.
Future Development
Mesoblast aims to develop more cell therapies using its remestemcel-L and rexlemestrocel-L platforms, targeting various inflammatory diseases and expanding partnerships in Japan, Europe, and China.
Motley Fool contributor Abbie Stokes has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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