Mesoblast Receives IND Clearance From FDA to Directly Proceed to Registrational Trial for Approval of Ryoncil® in Duchenne Muscular Dystrophy - CORRECTION
Mesoblast Limited - American Depositary Shares (MESO)
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Source: GlobeNewswire
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 approximately 15,000 children in the U.S.1 Ryoncil® is the first mesenchymal stromal cell (MSC) product approved by FDA, and the only product approved for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD)2. This new registrational trial builds on Ryoncil’s® proven safety in children, evidence of efficacy in DMD preclinical models, and FDA-
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News
- Mesoblast Acquires Chimeric Antigen Receptor (CAR) Platform Technology for Precision-Enhanced Cell ProductsGlobeNewswire
- ASX April 2026 Stocks Estimated To Be Trading Below Fair Value [Yahoo! Finance]Yahoo! Finance
- Mesoblast R&D Day: Ryonsel Gains Traction, Back Pain Phase III Nears Finish, New Shots on Goal [Yahoo! Finance]Yahoo! Finance
- Mesoblast R&D Day Features Significant Commercial Progress & Platform InnovationGlobeNewswire
- Mesoblast Receives IND Clearance from FDA to Directly Proceed to Registrational Trial for Approval of Ryoncil® in Duchenne Muscular Dystrophy [Yahoo! Finance]Yahoo! Finance
MESO
Sec Filings
- 4/13/26 - Form 4
- 4/10/26 - Form 4
- 4/1/26 - Form 3
- MESO's page on the SEC website