By Digifin Pty Ltd · About this coverage
Key Points
- FDA approved TIBA potency assay for commercial Ryoncil lot release
- TIBA used with existing IL-2Rα inhibition and CAP potency assays
- Applies to release and stability monitoring of commercial product lots
- Ryoncil remains FDA-approved MSC therapy for paediatric SR-aGvHD
About Mesoblast (ASX:MSB)
Mesoblast Limited is an ASX and Nasdaq-listed biotechnology company with locations in Australia, the United States and Singapore. It develops allogeneic mesenchymal lineage cell therapies for inflammatory diseases, including the FDA-approved product Ryoncil for steroid-refractory acute graft versus host disease.
Mesoblast Limited (ASX:MSB) has received United States Food and Drug Administration approval to implement a new potency assay for release and stability monitoring of commercial lots of its FDA-approved mesenchymal stromal cell product Ryoncil (remestemcel-L-rknd).
The new assay is the T-cell Proliferation Inhibition BioAssay (TIBA). Mesoblast says TIBA will provide sensitivity to detect shifts in potency that could arise from manufacturing process changes or production in new facilities. It will be used as part of a matrix to release each commercial batch of RYONCIL with existing potency assays that determine IL-2Rα inhibition and CAP (Cell Adhesion and Proliferation), as per the product's Biologics License. The company states RYONCIL is the first industrially manufactured allogeneic MSC product approved by the FDA for any indication, and the only MSC product approved for patients with steroid-refractory acute graft versus host disease aged 2 months or older.
The release does not quantify manufacturing volumes, sales, pricing, or timelines for additional indications under development.
Source: Mesoblast Limited (ASX:MSB), 24 September 2026. Summary content supplied by Digifin Pty Ltd.
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