Mesoblast books US$115M from first full year of Ryoncil sales in US

Mesoblast has put a number on its first full year as a commercial-stage company in the US: net revenue of US$115M for fiscal 2026, all tied to Ryoncil. The company describes the product as the first mesenchymal stromal cell therapy cleared by the US Food and Drug Administration. The figure comes from a corporate presentation, and the material available does not break down quarterly trends or give a profit measure.

The company also reported progress on reimbursement and funding. It says 98% of US covered lives now have a J-code in place, the billing identifier that matters for how a specialist product is claimed and paid. Separately, Mesoblast cited a US$125M five-year credit facility that replaces two more expensive facilities. Pricing terms and the cost saving were not provided in the summary we have seen.

Beyond the current indication, the company is working to widen Ryoncil's use. A registration trial in adults with steroid-refractory acute graft-versus-host disease is enrolling, and the FDA has cleared an investigational new drug application for a Phase 3 study in paediatric Duchenne muscular dystrophy. Both are label-expansion steps rather than approvals, and no timelines were given.

In the wider pipeline, Mesoblast says 350 patients have been treated in its Phase 3 trial of rexlemestrocel-L in chronic low back pain. It also reports FDA alignment on a filing path for the same product in end-stage heart failure, though the presentation did not describe what that path involves. That claim is the company's own and should be treated as such until more detail emerges.

Mesoblast also noted changes to its management and board. The summary of the presentation did not say who is affected or when.