Mesoblast Achieves FDA Approval for Ryoncil®

Tip Ranks
2025.11.25 14:58
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Mesoblast Limited announced FDA approval for Ryoncil®, a therapy for steroid-refractory acute graft-versus-host disease in children, marking a major milestone. This approval transitions Mesoblast from development to commercialization, validating its scientific platform and strategy. The company plans to expand Ryoncil®'s use and seek further FDA approvals. Despite financial challenges, Mesoblast shows potential for future growth. The stock is rated Hold with a $14.50 target.

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An update from Mesoblast ( (MESO) ) is now available.

On November 25, 2025, Mesoblast Limited announced at its Annual General Meeting that it has achieved FDA approval for Ryoncil®, a mesenchymal stromal cell therapy for steroid-refractory acute graft-versus-host disease in children. This approval marks a significant milestone for Mesoblast, transitioning the company from development to commercialization with strong sales and reimbursement coverage. The success of Ryoncil® validates Mesoblast’s scientific platform and commercialization strategy, and the company is now expanding its use to additional indications and preparing for further FDA approvals for other products in its pipeline.

The most recent analyst rating on (MESO) stock is a Hold with a $14.50 price target. To see the full list of analyst forecasts on Mesoblast stock, see the MESO Stock Forecast page.

Spark’s Take on MESO Stock

According to Spark, TipRanks’ AI Analyst, MESO is a Neutral.

Mesoblast’s overall stock score is driven by financial challenges and bearish technical indicators. Despite strong revenue growth and positive earnings call highlights, the company’s profitability issues and negative valuation metrics weigh heavily on the score. The potential for future growth, as indicated in the earnings call, provides some optimism.

To see Spark’s full report on MESO stock, click here.

More about Mesoblast

Mesoblast is a leading company in the development of allogeneic cellular medicines aimed at treating severe and life-threatening inflammatory conditions. The company’s proprietary mesenchymal lineage cell therapy technology platform focuses on responding to severe inflammation by releasing anti-inflammatory factors, significantly reducing the damaging inflammatory process. Mesoblast has a strong global intellectual property portfolio and is listed on the Australian Securities Exchange and Nasdaq.

Average Trading Volume: 240,229

Technical Sentiment Signal: Buy

Current Market Cap: $1.93B

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