J-Code
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Ryoncil® Net Revenues Increase 69% in Second Quarter Post-Launch
Mesoblast (MESO) reported Q1 FY2026 results with cell therapy revenue of $20.6M, up from $12.9M sequentially. Ryoncil gross sales rose 66% to $21.9M; net sales increased 69% to $19.1M after adjustments. A permanent Ryoncil J-code (J3402) became active 10/1/25 and federal Medicaid coverage is mandatory from 7/1/25. The company held $145M cash and secured convertible note agreements for up to $50M (subject to approval). They onboarded 40 transplant centers with coverage over 260M lives.
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Ryoncil® Granted J-Code by CMS, Streamlining Reimbursement and Expanding Patient Access
Mesoblast Limited announced that the permanent J-Code J3402 for Ryoncil, its cell therapy for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients, became effective on October 1, 2025. Assigned by CMS, the code aims to streamline billing and reimbursement, potentially broadening patient access to this first FDA-approved mesenchymal stromal cell product. While seen as positive, commercial payer adoption is crucial for realizing Ryoncil’s full potential. Healthcare providers can now utilize J3402 for claims submitted for services rendered on or after October 1, 2025.