October 3, 2025 — Leads & Copy — Mesoblast Limited (Nasdaq:MESO; ASX:MSB) announced that a specific Healthcare Common Procedure Coding System (HCPCS) J-Code assigned to Ryoncil® (remestemcel-L-rknd) by United States Medicare & Medicaid Services (CMS) became active for billing and reimbursement on October 1, 2025. Formal recognition by CMS is a significant milestone as the product becomes easier to bill and pay for.
The new permanent J-Code, J3402, provides a standardized, clear, permanent, and specific billing pathway for Ryoncil® by Medicaid, facilitating reimbursement and broader patient access. Commercial payers also look to the permanent J-code to update their coverage systems.
Ryoncil® is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication, and the only product approved for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD).
Mesoblast Chief Executive Dr. Silviu Itescu said 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.
Healthcare providers can begin using J3402 for claims submitted on or after October 1, 2025. For detailed coding and billing guidance, providers are encouraged to consult ryoncil.com.
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. Mesoblast’s Ryoncil® (remestemcel-L-rknd) is the first FDA-approved mesenchymal stromal cell (MSC) therapy for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older.
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.
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. The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines.
The company has locations in Australia, the United States and Singapore.
Contact:
Paul Hughes
T: +61 3 9639 6036
Emma Neal
T: +1 603 545 4843
E: emma.neal@allisonworldwide.com
Steve Dabkowski
T: +61 419 880 486
E: steve@bluedot.net.au
Source: Mesoblast Limited
