Mesoblast’s Ryoncil Launch Sparks 191% Revenue Surge in FY2025
Mesoblast reports a strong FY2025 financial performance driven by the commercial launch of Ryoncil, the first FDA-approved mesenchymal stromal cell therapy for steroid-refractory acute graft-versus-host disease in children. The company is advancing multiple clinical programs targeting inflammatory diseases, heart failure, and chronic low back pain.
- FY2025 revenue from cell therapy products up 191%, led by Ryoncil launch
- Ryoncil approved by FDA and commercially available since March 2025
- Ongoing Phase 3 trials for chronic low back pain and label expansion for Ryoncil
- REVASCOR progressing toward accelerated FDA approval for heart failure
- Strong market opportunities across inflammatory diseases, heart failure, and CLBP
Mesoblast’s Breakthrough Year
Mesoblast has delivered a standout financial and operational update for the full year ended June 30, 2025, propelled by the successful commercial launch of Ryoncil. This product, the first FDA-approved mesenchymal stromal cell therapy for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in children, generated US$17.2 million in revenue from cell therapy products, marking a 191% increase over the prior year. The launch, which began in March 2025, saw rapid uptake with 32 US transplant centers onboarded and plans to reach 45 centers covering 80% of pediatric bone marrow transplants within the quarter.
Ryoncil’s Clinical and Commercial Momentum
Ryoncil’s approval and commercial availability represent a significant milestone for Mesoblast and the broader field of allogeneic cellular medicines. The therapy addresses a critical unmet need in children with SR-aGvHD, a condition with high mortality and costly hospital stays. Clinical data underpinning Ryoncil show a 70% overall response rate at Day 28, a key predictor of survival, with long-term survival rates near 50% at four years. The company is also advancing label expansion trials to extend Ryoncil’s use to adults with severe SR-aGvHD and inflammatory colitis, potentially tripling the addressable patient population.
Pipeline Progress and Market Potential
Beyond Ryoncil, Mesoblast is actively progressing its pipeline, including Phase 3 trials for rexlemestrocel-L targeting chronic low back pain (CLBP) and preparing for an accelerated approval filing for REVASCOR in heart failure with reduced ejection fraction (HFrEF). The heart failure program recently aligned with the FDA on key regulatory requirements, aiming to leverage the Regenerative Medicine Advanced Therapy designation. Mesoblast highlights substantial market opportunities, with addressable markets estimated at over US$1 billion for SR-aGvHD, US$5 billion for inflammatory bowel disease, and more than US$10 billion each for heart failure and CLBP.
Financial Discipline Amid Growth
While revenues surged, Mesoblast’s net operating cash spend increased modestly by 3% to US$50 million, reflecting investments in commercial infrastructure and product launch activities. Gross margins on product sales remain robust at 90%, underscoring operational efficiency. The company ended the fiscal year with a strong cash position of US$162 million, providing a solid runway to support ongoing clinical development and commercialization efforts.
Looking Ahead
Mesoblast’s FY2025 results mark a pivotal step in translating its allogeneic cellular medicine platform into commercial success and clinical impact. The company’s strategic focus on expanding indications for Ryoncil, advancing late-stage trials for rexlemestrocel-L, and pursuing accelerated approval for REVASCOR sets the stage for continued growth. Investors and stakeholders will be watching closely as upcoming clinical data and regulatory milestones unfold, potentially reshaping treatment paradigms in inflammatory diseases and heart failure.
Bottom Line?
Mesoblast’s momentum from Ryoncil’s launch and pipeline progress positions it for transformative growth, but upcoming trial results and regulatory decisions will be critical to watch.
Questions in the middle?
- How will Mesoblast’s adult SR-aGvHD trial impact Ryoncil’s market potential?
- What are the timelines and expectations for REVASCOR’s accelerated FDA approval?
- Can rexlemestrocel-L’s Phase 3 trial deliver definitive evidence for chronic low back pain treatment?
