Mesoblast (MESO) Gets 7 Years of Orphan-drug Exclusive Approval from US FDA for Ryoncil
Mesoblast Limited (NASDAQ:MESO) is one of the 7 Best ASX Stocks to Buy Now. The company announced that it received 7 years of orphan-drug exclusive approval from the US FDA for Ryoncil® (remestemcel-L) for treating steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older. This period of statutory exclusivity exhibits that the US FDA will not be approving any other mesenchymal stromal or stem cell (MSC) products for this indication during a 7-year period from the approval date of Ryoncil®.
A biotechnologist in a lab suit studying a syringe with a mesenchymal lineage cells inside.
Furthermore, Mesoblast Limited (NASDAQ:MESO) possesses biologic exclusivity preventing another sponsor from referencing the Ryoncil® biologic license application (BLA) till December 2036, 12 years from the 1st approval, preventing market entry by the biosimilar. Apart from such statutory exclusivities, Mesoblast Limited (NASDAQ:MESO) possesses a robust US intellectual property position on MSC composition of matter, manufacturing, and indications, including SR-aGvHD, which offers a commercial barrier to entry against the competitors through 2044.
While we acknowledge the potential of MESO to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than MESO and that has 100x upside potential, check out our report about this cheapest AI stock.
READ NEXT: 13 Cheap AI Stocks to Buy According to Analysts and 11 Unstoppable Growth Stocks to Invest in Now
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