Mesoblast (ASX:MSB) is set to launch its Ryoncil mesenchymal stromal cell therapy in the US during the first quarter for pediatric patients two months and older with steroid-refractory acute graft-versus-host disease, according to a Friday Australian bourse filing.
The therapy was approved by the US Food and Drug Administration in December 2024. The firm is now awaiting national drug codes from the regulator, which will allow for the publication of product pricing in the US price compendia.
The firm's commercial inventory has been manufactured and a distribution network has been established using specialty pharmaceutical services and distribution firm Cencora.
Its commercial launch strategy will initially target centers with experience using the therapy at high volume, followed by a broader staged rollout.
The firm has been working on finalizing product availability, including logistics, regulatory documentation, and contractual arrangements ahead of the launch, its chief executive Silviu Itescu said.
It is also collaborating with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) in the US to conduct a trial in adults with the disease.
The firm's shares rose almost 2% in recent trading on Friday.
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