Mesoblast Shares Climb on Strong Ryoncil Sales Forecast
FDA & Biotech

Mesoblast Shares Climb on Strong Ryoncil Sales Forecast

Company projects over 37% sequential quarterly growth for its recently approved cell therapy, signaling a robust commercial launch in the U.S. market.

Mesoblast Ltd. (NASDAQ: MESO) saw its shares rise in Tuesday trading after the regenerative medicine company signaled accelerating demand for its flagship cell therapy, Ryoncil (remestemcel-L), during its Annual General Meeting.

The company announced it expects gross revenue from Ryoncil to surpass $30.0 million for the quarter ending December 31, a significant sequential increase of more than 37% from the $21.9 million reported in the prior quarter. Shares of Mesoblast traded up 1.6% to $15.62 on the news, reflecting investor optimism about the drug's successful commercial trajectory following its recent regulatory approval.

This strong sales forecast is a critical validation of Mesoblast's strategy, marking a successful transition from a clinical-stage firm to a commercial-stage enterprise. The growth is directly tied to the U.S. Food and Drug Administration's (FDA) approval of Ryoncil in December 2024 for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients.

"The continued strong growth in Ryoncil revenue highlights a significant unmet need for this complication of bone marrow transplantation in children," the company stated in its trading update released via GlobeNewswire.

Acute GVHD is a life-threatening condition that can occur in patients following a bone marrow transplant, where the donor's immune cells attack the recipient's body. For pediatric patients who do not respond to steroid treatments, outcomes are often poor, making Ryoncil a vital new therapeutic option.

Adding to its commercial prospects, the FDA granted Ryoncil seven years of orphan-drug exclusivity in May 2025. This designation provides a significant competitive buffer, preventing the approval of similar mesenchymal stem cell (MSC) products for the same indication until 2032 and securing a long runway for revenue growth.

With a market capitalization of nearly $2 billion, Mesoblast is now positioned to leverage the Ryoncil revenue stream to advance its broader pipeline of allogeneic cellular therapies targeting cardiovascular and inflammatory conditions. The successful launch provides a crucial source of non-dilutive capital, reducing reliance on equity markets to fund future research and development.

Wall Street has taken a bullish stance on the company's prospects. Analyst consensus rates Mesoblast as a 'Strong Buy,' with an average 12-month price target of $35.00. This suggests a potential upside of over 120% from its current trading level, indicating that analysts believe the current share price does not fully reflect Ryoncil's long-term sales potential and the value of the company's underlying technology platform.

As Mesoblast continues its U.S. market rollout, investors will be closely monitoring the company's ability to maintain this steep growth curve. The upcoming quarterly earnings report will be a key data point to confirm if the robust demand for Ryoncil is sustained, cementing the therapy's position as a cornerstone commercial asset for the Australian biotech firm.