Ryoncil® Revenues Increase 66% in Second Quarter Post Launch
Mesoblast (Nasdaq: MESO) reported gross Ryoncil sales of US$21.9 million for the quarter ended September 30, 2025, a 66% increase versus the prior quarter ended June 30, 2025 with a similar gross-to-net adjustment.
Ryoncil (remestemcel-L-rknd) is the first FDA-approved mesenchymal stromal cell product and the only product approved for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD). Management cited payer reimbursement progress and noted adoption is expected to accelerate following a permanent CMS J-Code effective October 1, 2025.
Mesoblast (Nasdaq: MESO) ha riportato vendite lorde di Ryoncil pari a 21,9 milioni di dollari USA per il trimestre terminato il 30 settembre 2025, con un aumento del 66% rispetto al trimestre precedente terminato il 30 giugno 2025, con un aggiustamento lordo-netto simile.
Ryoncil (remestemcel-L-rknd) è il primo prodotto a base di cellule stromali mesenchimali approvato dalla FDA e l'unico prodotto approvato per bambini sotto i 12 anni con malattia da rigetto acuto correlata al trapianto resistente agli steroidi (SR-aGvHD). Il management ha citato progressi nel rimborso da parte dei payer e ha osservato che l'adozione dovrebbe accelerare dopo un Codice J permanente CMS in vigore dal 1° ottobre 2025.
Mesoblast (Nasdaq: MESO) reportó ventas brutas de Ryoncil de 21,9 millones de dólares para el trimestre que terminó el 30 de septiembre de 2025, un aumento del 66% frente al trimestre anterior que terminó el 30 de junio de 2025 con un ajuste bruto a neto similar.
Ryoncil (remestemcel-L-rknd) es el primer producto de células madre mesenquimales aprobado por la FDA y el único producto aprobado para niños menores de 12 años con enfermedad injerto contra huésped aguda esteroide-resistente (SR-aGvHD). La dirección citó avances en el reembolso por parte de los pagadores y comentó que se espera que la adopción se acelere tras un Código J permanente de CMS vigente a partir del 1 de octubre de 2025.
메사볼랩(Mesoblast, Nasdaq: MESO)는 2025년 9월 30일 종료 분기의 Ryoncil 매출 총액이 미화 2190만 달러를 기록했다고 발표했으며, 2025년 6월 30일 종료 분기 대비 66% 증가했고, 총액 순액 조정은 유사하게 적용되었습니다.
Ryoncil (remestemcel-L-rknd)은 FDA에서 승인된 최초의 중간엽 줄기세포 제품이며 12세 미만의 소아에게 승인된 유일한 제품으로, 스테로이드에 반응하지 않는 급성 이식편대숙주병(SR-aGvHD)을 가진 경우에 한합니다. 경영진은 지불자 상환 진행 상황을 언급했고, 2025년 10월 1일 발효 예정인 CMS의 영구적인 J-code가 채택을 가속화할 것으로 기대한다고 밝혔습니다.
Mesoblast (Nasdaq: MESO) a annoncé des ventes brutes de Ryoncil de 21,9 millions de dollars américains pour le trimestre clos le 30 septembre 2025, soit une augmentation de 66% par rapport au trimestre précédent clos le 30 juin 2025, avec une adaptation brute-to-net similaire.
Ryoncil (remestemcel-L-rknd) est le premier produit à base de cellules stromales mésenchymateuses approuvé par la FDA et le seul produit approuvé pour les enfants de moins de 12 ans atteints de maladie du greffon contre l'hôte aiguë résistante aux corticostéroïdes (SR-aGvHD). La direction a évoqué les progrès du remboursement par les payeurs et a noté que l'adoption devrait s'accélérer après qu'un code J CMS permanent entre en vigueur le 1er octobre 2025.
Mesoblast (Nasdaq: MESO) meldete Bruttoverkäufe von Ryoncil in Höhe von 21,9 Mio. US-Dollar für das Quartal, das am 30. September 2025 endete, eine 66%-ige Steigerung gegenüber dem Vorquartal, das am 30. Juni 2025 endete, mit einer ähnlichen Brutto-zu-Netto-Anpassung.
Ryoncil (remestemcel-L-rknd) ist das erste von der FDA genehmigte Produkt auf Basis von mesenchymalen Stromazellen und das einzige Produkt, das für Kinder unter 12 Jahren mit steroidrefraktärem akuten Graft-versus-Host-Disease (SR-aGvHD) zugelassen ist. Das Management verwies auf Fortschritte bei der Kostenerstattung durch Kostenträger und bemerkte, dass die Einführung voraussichtlich nach Inkrafttreten eines permanenten CMS J-Code ab dem 1. Oktober 2025 beschleunigt wird.
ميسابلوب (ناسداك: MESO) أبلغت عن إيرادات إجمالية لـ Ryoncil تبلغ 21.9 مليون دولار أمريكي للربع المنتهي في 30 سبتمبر 2025، وهي زيادة نسبتها 66% مقارنةً بالربع السابق المنتهي في 30 يونيو 2025 مع تعديل إجمالي إلى صافي مماثل.
Ryoncil (remestemcel-L-rknd) هو أول منتج من الخلايا العقدية الوسيطة المعتمَد من FDA والوحيد المعتمد لـ الأطفال دون سن 12 عامًا المصابين بمرض الرد على الزراعة المِسنِّة الحاد المرتبط بقلّة الاستجابة للستيرويدات (SR-aGvHD). أشار الفريق الإداري إلى تقدم في سداد مُعالِجي التأمين وتوقع أن يتسارع الاعتماد بعد رمز CMS J دائم يبدأ من 1 أكتوبر 2025.
Mesoblast (纳斯达克：MESO) 报告 截至2025年9月30日季度的 Ryoncil 毛销售额为 2190 万美元，较前一季度（截至2025年6月30日）增长 66%，并且毛额到净额的调整相似。
Ryoncil（remestemcel-L-rknd）是FDA批准的第一种间充质干细胞产品，也是唯一获批用于 12岁以下儿童 的药物，适用于对类固醇反应不足的急性移植物抗宿主病（SR-aGvHD）。管理层提到支付方报销方面的进展，并指出在自2025年10月1日起生效的 CMS 永久性 J-Code 出现后，采用率预计将加速。
- Revenue US$21.9 million in Q3 2025
- Quarterly sales growth +66% QoQ
- Permanent CMS J-Code effective October 1, 2025
- Approved indication limited to children under 12 with SR-aGvHD
NEW YORK, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced gross revenue of US
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).1
Mesoblast Chief Executive Dr. Silviu Itescu said: “We are very pleased with the adoption of Ryoncil® to date and with reimbursement by both commercial and government payers. We expect adoption to be further enhanced following the permanent J-Code assigned by Centers for Medicare and Medicaid Services (CMS) which became active October 1.”
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
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.
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FAQ
How much did Mesoblast (MESO) report in Ryoncil revenue for Q3 2025?
What was the quarter-over-quarter change in Ryoncil sales for MESO in Q3 2025?
What FDA-approved indication does Ryoncil have for MESO?
How might the CMS J-Code affect MESO adoption of Ryoncil?
Did Mesoblast report any gross-to-net adjustments for Ryoncil sales in Q3 2025?
