Ryoncil® Granted J-Code by CMS, Streamlining Reimbursement and Expanding Patient Access

10/02/2025 – 09:04 PM

NEW YORK, Oct. 02, 2025 — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), a global player in allogeneic cellular medicines targeting inflammatory diseases, announced a significant milestone today as the permanent Healthcare Common Procedure Coding System (HCPCS) J-Code, J3402, for Ryoncil^® (remestemcel-L-rknd) became active on October 1, 2025. This code, assigned by United States Medicare & Medicaid Services (CMS), streamlines billing and reimbursement processes, which the company believes will enhance access to this critical therapy.

The activation of J3402 signifies a major step forward for Ryoncil^®, as it provides a standardized billing pathway for Medicaid. This is expected to greatly facilitate reimbursement for healthcare providers, and potentially broaden patient access, particularly for the vulnerable pediatric population suffering from steroid-refractory acute graft-versus-host disease (SR-aGvHD). Industry analysts see this J-code as a potentially positive development, but caution that commercial payer adoption will be crucial to fully realize Ryoncil’s commercial potential.

Ryoncil^® holds a unique position in the market as the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication. It is also the sole therapy approved for children under the age of 12 grappling with SR-aGvHD, a severe and life-threatening complication following stem cell transplantation. The disease occurs when the donor’s immune cells attack the recipient’s tissues.

Mesoblast Chief Executive Dr. Silviu Itescu underscored the importance of the J-Code, stating, “A permanent J-Code is a critical element for successful commercialization of rare disease products, ensuring more efficient billing and enabling timely access to Ryoncil^® for children with life-threatening SR-aGvHD.” This comment underscores the logistical hurdles that often impede adoption of novel therapies, and how standardization of the billing process by CMS is one step forward toward more reliably accessing these drugs for patients that need them.

Healthcare providers can now utilize J3402 for claims submitted for services rendered on or after October 1, 2025. Mesoblast directs providers to ryoncil.com for comprehensive coding and billing guidance. Experts note that although the J-Code is a positive step, ultimate coverage decisions rest with individual payers, and consistent reimbursement across various insurance plans is not assured.

About Mesoblast
Mesoblast (the Company) is a global leader focused on developing allogeneic (off-the-shelf) cellular medicines. Mesoblast is concentrating its efforts on severe and life-threatening inflammatory conditions. The company’s proprietary mesenchymal lineage cell therapy technology platform leverages cells to respond to substantial inflammation by releasing anti-inflammatory factors. These, in turn, modulate multiple effector arms of the immune system, leading to a decline in the damaging inflammatory processes.

Mesoblast’s Ryoncil^® (remestemcel-L-rknd) represents a pioneering approach to treating steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged two months and older and currently is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Prescribing Information is available at www.ryoncil.com.

Mesoblast is dedicated to building additional cell therapies for distinct indications which are based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Currently, Ryoncil^® is being developed for other 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 ongoing established commercial partnerships in Japan, Europe and China.

About Mesoblast intellectual property: With over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications, Mesoblast’s global intellectual property portfolio is extensive. Commercial protection of these patents and patent applications is expected through at least 2041 in the core markets.

About Mesoblast manufacturing: Mesoblast’s exclusive manufacturing processes create scalable, cryopreserved, and off-the-shelf, cellular medicines. Designed to meet pharmaceutical release needs these cell therapies are planned to be globally available to patients.

Mesoblast maintains international locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). More information can be found at www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

References / Footnotes

1. https://www.cms.gov/files/document/r13425cp.pdf
2. Please see the full Prescribing Information at www.ryoncil.com.
3. Coding and coverage decisions are made by payers, and coverage cannot be guaranteed.

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.

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