Mesoblast Announces First Revenue Figures for Ryoncil, Offering Early Glimpse of Commercial Trajectory
Mesoblast has reported US$13.2 million in gross revenue for Ryoncil (remestemcel-L) in the first quarter following its March 28th launch. This initial performance provides a crucial early data point for assessing the commercial viability of the first and only FDA-approved mesenchymal stromal cell (MSC) product in the United States. The treatment addresses steroid-refractory acute graft-versus-host disease (SR-aGVHD) in children, a market with significant unmet need. The key question now is whether this early momentum can be sustained and scaled.
The company’s strategic focus on onboarding major transplant centers appears to be progressing, with over 25 centers already integrated and the remaining priority centers expected to be onboarded this quarter. These 45 centers represent approximately 80% of US pediatric transplants, highlighting the concentrated nature of the target market and the importance of effective HCP engagement. Securing payer coverage is another critical piece of the puzzle. With over 250 million lives now covered by commercial and government payers, along with newly effective mandatory Medicaid coverage, access barriers are diminishing. This development will be closely watched by other cell therapy companies navigating the complex reimbursement landscape.
The broader context of this launch is significant. Ryoncil’s entry represents a landmark moment for the advanced therapies sector, potentially paving the way for other MSC-based products. The seven-year orphan drug exclusivity and twelve-year biologic exclusivity provide Mesoblast with a substantial window to establish market dominance. However, the long-term success of Ryoncil will depend not only on market access and uptake but also on building a robust body of real-world evidence to solidify its clinical value proposition and justify its premium pricing.
Looking ahead, Mesoblast’s strategy appears to be two-pronged: solidifying its position in the pediatric SR-aGVHD market while simultaneously pursuing label expansion into adult SR-aGVHD. The planned pivotal trial in adults, to be conducted with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN), could significantly expand the addressable market for Ryoncil. The FDA’s feedback on this trial design will be a critical inflection point. Further, Mesoblast’s pipeline activities in other inflammatory diseases, including biologically resistant inflammatory bowel disease, signal an ambition to leverage its MSC platform across multiple indications. The company’s success in navigating these complex development and commercialization pathways will be a crucial bellwether for the future of MSC-based therapies.
Source link: https://www.globenewswire.com/news-release/2025/07/18/3117698/0/en/Successful-Commercial-Launch-of-Ryoncil.html
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
