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Mesoblast reports US$115M first full-year Ryoncil revenue as late-stage programmes advance

Mesoblast Ltd (MESO) · Thu 12 Nov 2026

Mesoblast says FY2026 net revenue reached US$115M in the first full year of US sales of Ryoncil, while its pipeline and label-expansion studies progressed.

Mesoblast reported net revenue of US$115M for fiscal year 2026 in a corporate presentation. It was the first full year of US sales of Ryoncil, which the company describes as the first mesenchymal stromal cell therapy approved by the US Food and Drug Administration.

On the pipeline, the company said 350 patients have been treated in its Phase 3 trial of rexlemestrocel-L in chronic low back pain. It also reported FDA alignment on a filing path for the product in end-stage heart failure. The presentation gave no further detail on that path.

Mesoblast is also expanding Ryoncil into new populations. A registration trial in adults with steroid-refractory acute graft-versus-host disease (SR-aGvHD) is now enrolling. The FDA has cleared an investigational new drug application for a Phase 3 study in paediatric Duchenne muscular dystrophy.

On commercial and corporate matters, Mesoblast cited a US$125M five-year credit facility that replaces two costlier facilities. It said 98% of US covered lives have a J-code in place, and it noted changes to management and the board. The presentation, as summarised, did not give details of the changes.

What it means for your team

  • Market-access teams may note that the company reports J-code coverage for 98% of US covered lives, which is relevant to billing and reimbursement of a cell therapy.
  • Regulatory teams can track the adult SR-aGvHD registration trial and the paediatric Duchenne Phase 3 as label-expansion steps for Ryoncil.
  • The reported FDA alignment on a filing path in end-stage heart failure is a company statement; details of the agreed path were not provided.

Company's press release (SEC filing): Mesoblast Ltd ↗

Article written by VigiEye from the official source (Mesoblast Ltd). Claims are the company's own. AI-assisted; check the source before acting.

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