Mesoblast Limited Surges as Ryoncil U.S. Revenue Jumps 66% in September Quarter

Highlights:

• Mesoblast Limited (ASX: MSB) shares surged ~10.5% at the time of writing after reporting a 66% increase in U.S. Ryoncil revenue for the September quarter.
• The rally was driven by strong adoption and the activation of a permanent J-Code by U.S. CMS, streamlining reimbursement for Ryoncil.
• Ryoncil remains the only FDA-approved therapy for children under 12 diagnosed with steroid-refractory acute graft-versus-host disease (SR-aGvHD), highlighting its pivotal role in this specialized treatment area.

Mesoblast Limited (ASX: MSB) shares climbed around 10.5% at the time of writing after the company announced that U.S. revenue from Ryoncil, its treatment for severe complications in children following bone marrow transplants, rose by 66% in the September quarter. This strong result underscores a pivotal moment for the biotech as it strengthens its foothold in the allogeneic cell therapy market.

Revenue Growth Lifts Investor Sentiment

For the quarter ending September 30, Mesoblast reported US $21.9 million in gross revenue from Ryoncil, representing a 66% increase from the previous quarter. At the time of writing, this figure reflects the most recent financial data released by the company.

The sharp rise in revenue boosted investor sentiment, driving a significant double-digit increase in the company’s share price. Analysts have credited both increased market adoption and improved reimbursement mechanisms in the United States for this rally.

CMS Reimbursement Support Drives Uptake

Industry observers attribute part of the market’s positive response to the activation of a permanent J-Code by the U.S. Centers for Medicare & Medicaid Services (CMS) on October 1. The new code streamlines billing and reimbursement for hospitals, which Mesoblast believes will help accelerate Ryoncil’s uptake across the U.S. healthcare system.

A Breakthrough Therapy in a Specialized Market

Ryoncil (remestemcel-L) occupies a pivotal place in Mesoblast’s portfolio as it was the first mesenchymal stromal cell (MSC) therapy to receive FDA approval for any condition. It remains the exclusive approved treatment for children under 12 diagnosed with steroid-refractory acute graft-versus-host disease (SR-aGvHD), highlighting its critical importance in this niche area of the market.

Although the therapy targets a rare condition, the notable revenue growth reflects steady progress in a specialized, high-barrier market. Mesoblast is also pursuing opportunities to expand the use of its cell-based therapies in adult and other inflammatory diseases.

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