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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 m

Key Takeaway: Mesoblast Limited has reaffirmed that its allogeneic cell therapy products, particularly Ryoncil, are manufactured from U.S. donors and are exempt from tariffs. Ryoncil, the only FDA-approved mesenchymal stromal cell therapy for steroid-refractory acute graft versus host disease in pediatric patients, is underscored by a robust global patent portfolio. The company is also pursuing further developments and potential approvals for additional inflammatory diseases while maintaining strategic commercial partnerships across key international markets.
Price reaction · baseline $15.86 (2025-09-26 close) · clean, no other MESO news in the window
day 0 close · peak
+1%

Market Sentiment Analysis

POSITIVE FACTORS

  • Mesoblast's cell therapy products are designated as U.S. origin, avoiding tariffs.
  • Ryoncil is the first FDA-approved MSC therapy for pediatric patients.
  • Strong global patent portfolio protects Mesoblast's innovations until at least 2041.
  • The company is engaged in various partnerships in key markets internationally.

CONCERNS & RISKS

  • Forward-looking statements include risks that actual results may differ materially.
  • Potential for market withdrawal of product candidates due to patient adverse events.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+91%
120-day peak, hindsight
Typical move
31.6%
average across 4 past catalysts
Lead asset
Prochymal
Phase 2 · Pulmonary Disease, Chronic Obstructive

Full Press Release Details

MESOBLAST CELL THERAPY PRODUCTS ARE DESIGNATED U.S. ORIGIN AND NOT SUBJECT TO TARIFFS Melbourne, Australia; and New York, USA; September 26, 2025: Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today reiterated that its allogeneic cell therapy products are manufactured from U.S. donors in the U.S. and designated as U.S. origin products not subject to tariffs on imported branded or patented pharmaceutical products. Ryoncil (remestemcel-L) is the only allogeneic mesenchymal stromal cell therapy approved by U.S. Food and Drug Administration (FDA) for any indication. As documented in the Company's Biologic License Application (BLA), Ryoncil is designated a U.S. Country of Origin' product in line with U.S. FDA and Customs regulatory guidance. Ryoncil is approved for treatment of pediatric patients 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft versus host disease (SR-aGvHD), a condition with high mortality rates. Mesoblast continues to ensure that all its products, whether for SR-aGvHD, chronic heart failure, chronic back pain, or other inflammatory indications, are manufactured from U.S. donors at U.S. sites. 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 are expected to provide commercial protection extending through to at least 2041 in 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 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 Exhibit 99.1
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 Allison Worldwide Emma Neal T: +1 603 545 4843 E: emma.neal@allisonworldwide.com Media - Australia BlueDot Media Steve Dabkowski T: +61 419 880 486 E: steve@bluedot.net.au

Frequently Asked Questions

What are Mesoblast's cell therapy products designated as?

Mesoblast's cell therapy products are designated as U.S. origin.

Is Ryoncil approved by the FDA for pediatric patients?

Yes, Ryoncil is approved for pediatric patients aged 2 months and older.

What condition does Ryoncil treat?

Ryoncil treats steroid-refractory acute graft versus host disease (SR-aGvHD).

Where are Mesoblast's cell therapies manufactured?

Mesoblast manufactures its cell therapies from U.S. donors at U.S. locations.

What does Mesoblast's intellectual property cover?

Mesoblast's intellectual property covers cell compositions, manufacturing methods, and indications.

Last updated: Sep 29, 2025