Mesoblast gains FDA clearance for a new Ryoncil potency assay

Mesoblast ($MESO) received FDA approval to use a new potency assay for the release and stability testing of newly manufactured commercial Ryoncil batches. The TIBA assay is intended to identify changes in product potency, including those associated with manufacturing processes or the addition of production facilities. It complements the company’s existing testing methods.

The decision concerns quality control for an already approved cell therapy, not a new treatment indication or an additional drug approval. Ryoncil’s US indication remains pediatric steroid-refractory acute graft-versus-host disease in patients aged two months and older. Mesoblast did not quantify an immediate increase in production capacity or revenue from the assay decision. Its significance is the regulatory acceptance of an additional method for monitoring commercial product consistency.

Sources:

• Mesoblast — commercial potency-assay announcement