Remestemcel-L (RYONCIL®)
Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD) in children
Phase 3BLA under Priority Review (PDUFA Aug 2, 2024)
Key Facts
Indication
Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD) in children
Phase
Phase 3
Status
BLA under Priority Review (PDUFA Aug 2, 2024)
Company
About Mesoblast
Mesoblast is a global leader in developing allogeneic (off-the-shelf) cellular medicines derived from its proprietary mesenchymal lineage cell technology platform. Its most advanced candidate, remestemcel-L, has a Biologics License Application (BLA) under priority review with the FDA for pediatric SR-aGVHD, with a PDUFA date of August 2, 2024. The company's strategic focus is on advancing its late-stage pipeline in inflammatory conditions with high unmet need while leveraging its scalable manufacturing platform.
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