Mesoblast Secures FDA Clearance for New Ryoncil Commercial Potency Assay
Mesoblast Limited (ASX: MSB) announced on 24 September 2026 that it has received approval from the US Food and Drug Administration (FDA) to implement a new potency assay for the commercial release and stability monitoring of its flagship mesenchymal stromal cell therapy product Ryoncil.
The newly approved T cell Proliferation Inhibition BioAssay (TIBA) will function within an existing testing matrix alongside current IL-2Ra inhibition and CAP (Cell Adhesion and Proliferation) assays required under the productβs Biologics License. This multi assay release protocol ensures each commercial batch maintains clinical efficacy, batch to batch consistency and adequate potency sensitivity during future manufacturing scale up or production facility transitions.
Management emphasized that the regulatory green light reinforces ongoing quality control alignment with the FDA following Ryoncilβs initial market approval. As the first industrially produced allogeneic MSC therapy cleared by the regulator, the platform addresses high unmet medical needs in pediatric patients aged two months and older suffering from steroid refractory acute graft versus host disease (SR-aGvHD).
The assay clearance supports Mesoblastβs broader commercial strategy to scale its cryopreserved, off the shelf allogeneic cell platforms across international markets. Remestemcel-L is concurrently undergoing development for adult SR-aGvHD and biologic resistant inflammatory bowel disease while the group advances rexlemestrocel-L programs in heart failure and chronic low back pain backed by a patent portfolio extending to 2044.
(Source: Company Announcements)
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