Ryoncil® Delivers Net Revenue of US$36M for the Fourth Quarter Ended 30 June 2026
Rhea-AI Summary
Mesoblast (Nasdaq:MESO; ASX:MSB) reported preliminary net revenue from Ryoncil® (remestemcel-L-rknd) of US$36 million for the quarter and US$115 million for the first full year ended June 30, 2026. Management said revenues have exceeded initial projections and that they expect revenue growth to continue in the next fiscal year, supported by momentum across major U.S. pediatric centers.
According to Mesoblast, the company’s capital position is strong and operational activities are well funded through revenue growth, with a new five-year facility supporting strategic initiatives for label extensions and potential blockbuster products. Ryoncil is described as the first mesenchymal stromal cell product approved by the U.S. FDA for any indication and the only FDA-approved therapy for children under 12 with steroid-refractory acute graft-versus-host disease. The revenue figures are based on management’s preliminary estimates and remain subject to customary year-end closing and audit procedures.
Positive
- US$36M Ryoncil® net revenue in Q4 FY2026
- First full-year Ryoncil® net revenue of US$115M ended June 30, 2026
- Management states revenues have exceeded initial projections for Ryoncil®
- Company reports strong capital position and operations funded through revenue growth
- Ryoncil® is the only FDA-approved therapy for SR-aGvHD in children under 12
Negative
- Reported revenue figures are preliminary and subject to year-end closing and audit procedures
News Market Reaction – MESO
In the Jul 10 session, MESO gained 4.11%, reflecting a moderate positive market reaction. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 30 | BLA filing update | Positive | +4.1% | FDA BLA filing number and modular review request for rexlemestrocel-L. |
| Jun 24 | Credit facility draw | Positive | -6.8% | US$50m non-dilutive facility draw to refinance higher-cost debt. |
| Apr 29 | Ryoncil revenue update | Positive | +0.8% | Quarterly Ryoncil revenues and improved net operating cash spend. |
| Apr 28 | Phase 3 recruitment | Positive | +2.2% | Pivotal Phase 3 chronic low back pain trial met recruitment target. |
| Apr 14 | CAR platform acquisition | Positive | +7.8% | Acquisition of CAR technology platform to engineer MSC-based products. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
MESO has generally traded in line with positive operational and clinical catalysts, with one notable divergence on financing news.
Key Terms
mesenchymal stromal cell medical
u.s. food and drug administration regulatory
steroid-refractory acute graft-versus-host disease medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Continued Growth Underpins First Full Year Net Revenue of US
NEW YORK, July 09, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced Ryoncil® (remestemcel-L-rknd) net revenue of US
Dr. Itescu added: “We anticipate continued revenue growth in the coming fiscal year in line with momentum we are seeing across major U.S. pediatric centers. Our capital position is strong, operational activities are well funded through revenue growth, and the new five-year facility has freed up our label extension and blockbuster products for strategic initiatives.”
Ryoncil® is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication and is the only FDA-approved product for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD).1
The results presented herein are based on management’s preliminary estimates and remain subject to completion of customary year end closing and audit procedures.
About Mesoblast
Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.
Mesoblast’s Ryoncil® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com.
Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China.
About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications provide commercial protection extending through to at least 2044 in all major markets.
About Mesoblast manufacturing: The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.
Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast
References / Footnotes
- Please see the full Prescribing Information at www.ryoncil.com
Forward-Looking Statements
This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.
Release authorized by the Chief Executive.
For more information, please contact:
| Corporate Communications / Investors | |
| Paul Hughes | |
| T: +61 3 9639 6036 | |
| Media – Global | Media – Australia |
| Rubenstein | BlueDot Media |
| Caroline Nelson | Steve Dabkowski |
| T: +1 703 489 3037 | T: +61 419 880 486 |
| E: cnelson@rubenstein.com | E: steve@bluedot.net.au |
