Mesoblast Reports US$115 Million In First-Year Ryoncil Revenue As FDA Expansion Plans Advance

Mesoblast Limited has reported strong financial and operational progress for the fourth quarter and full fiscal year ended June 30, 2026, driven by the continued commercial success of its flagship cell therapy, Ryoncil®. The company highlighted growing adoption of the treatment across major paediatric centres in the United States and outlined significant advances across its clinical development pipeline. According to Chief Executive Officer Dr. Silviu Itescu, the strong commercial performance of Ryoncil® provides a solid foundation for future growth while supporting the company's plans to achieve additional regulatory approvals.

Ryoncil® generated net revenue of US$36 million during the fourth quarter, bringing total revenue for its first full year following FDA approval to US$115 million, including US$66.5 million during the second half of the fiscal year. Mesoblast also reported a net operating cash spend of US$43.8 million for the full year, with operating cash spend falling to US$13.4 million during the second half. At the end of June 2026, the company held US$103 million in cash after drawing US$50 million from its existing five-year financing facility to repay all outstanding debt obligations.

Mesoblast is continuing to expand the commercial and clinical potential of Ryoncil®, which is currently approved by the U.S. Food and Drug Administration (FDA) for children with steroid-refractory acute graft-versus-host disease (SR-aGvHD). The company has now begun a registration trial aimed at extending the therapy's indication to adults with SR-aGvHD, a market estimated to be three times larger than the paediatric population. 

Patient enrolment is underway, and up to 40 clinical sites across the United States are expected to participate, covering approximately 60% of the country's annual adult allogeneic bone marrow transplant population. In addition, Mesoblast received FDA Investigational New Drug (IND) clearance to begin a registrational trial evaluating Ryoncil® in ambulatory children aged 5 to 9 years with Duchenne muscular dystrophy (DMD).

The company also reported progress with rexlemestrocel-L, its investigational therapy for chronic low back pain associated with degenerative disc disease. Mesoblast achieved its target of enrolling at least 300 patients in its pivotal Phase 3 clinical trial, with participants now being followed through the 12-month primary endpoint to evaluate pain reduction compared with placebo. The company also received a Biologics License Application (BLA) filing number from the FDA for rexlemestrocel-L in the prevention of life-threatening gastrointestinal bleeding in patients with end-stage heart failure supported by a left ventricular assist device (LVAD) and has requested a modular review of the application.

Beyond its clinical programmes, Mesoblast continued to strengthen its research and development strategy during the quarter. The company hosted its inaugural R&D Day in New York, where it unveiled next-generation mesenchymal stromal cell (MSC) technologies and announced the acquisition of an exclusive worldwide licence for a patented chimeric antigen receptor (CAR) technology platform. The new platform is designed to enhance the precision and potency of MSC-based therapies and is expected to support the development of treatments for ulcerative colitis, Crohn's disease, lupus nephritis, and other B-cell autoimmune diseases.

Overall, the fourth-quarter results highlight Mesoblast's continued commercial growth alongside steady progress across its clinical pipeline. With increasing Ryoncil® adoption, multiple late-stage development programmes advancing, and investments in next-generation cell therapy technologies, the company is positioning itself for future regulatory milestones and long-term expansion in the field of inflammatory and immune-mediated diseases.