Mesoblast Advances U.S. Commercial Launch of Ryoncil® for Pediatric SR-aGvHD, with Key Milestones Ahead

31 January 2025 | Friday | News

The company focuses on rapid availability of its FDA-approved treatment for steroid-refractory acute graft-versus-host disease in children, backed by a strong financing position to support growth and expansion.
Picture Courtesy | Public Domain

Picture Courtesy | Public Domain

Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases,  provided an update on the progress of the U.S. commercial launch of Ryoncil® (remestemcel-L) for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients 2 months and older and key upcoming milestones for its late-stage pipeline.

”We are committed to making our FDA approved product Ryoncil® available as quickly as possible to the many children with SR-aGVHD in need of life-saving therapy,” said Dr. Silviu Itescu, Chief Executive of Mesoblast. “The team has been working relentlessly on finalizing product availability, including logistics, regulatory documentation, and contractual arrangements to ensure a successful launch of Ryoncil® this quarter.”

“The successful financing of US$160 million (A$260 million) this month, which provides the Company with proforma cash on hand of approximately US$200 million (A$322 million), puts us in a strong position to execute the U.S. commercial launch activities of Ryoncil®, to expand the clinical indications of the product, and ensure that commercial manufacturing will meet projected product uptake and demand.”

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