Mesoblast receives FDA clearance for Duchenne muscular dystrophy trial

Go back to Mesoblast receives FDA clearance for Duchenne muscular dystrophy trial

Mesoblast Receives IND Clearance From FDA to Directly Proceed to Registrational Trial for Approval of Ryoncil® in Duchenne Muscular Dystrophy - CORRECTION

April 10, 2026 4:09 PM EDT

Working with Parent Project Muscular Dystrophy and the Duchenne Registry on patient identification and trial awareness efforts 

~15,000 children are living with DMD in the U.S.

NEW YORK, April 10, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX: MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance to directly proceed for a registrational clinical trial evaluating Ryoncil® (remestemcel-L-rknd) in Duchenne muscular dystrophy (DMD), which affects... More