Mesoblast Allogeneic Cell Therapy Products Are Designated ‘U.S. Country of Origin’ and Not Subject to U.S. Tariffs
Mesoblast (Nasdaq:MESO) announced that its allogeneic cellular products, including Ryoncil® and Revascor®, will not be subject to U.S. tariffs as they are designated as 'U.S. Country of Origin' products. The company's products are manufactured from U.S. donors within the United States.
Ryoncil® holds the distinction of being the only FDA-approved allogeneic mesenchymal stromal cell therapy for any indication. It is specifically approved for treating pediatric patients 2 months and older with steroid-refractory acute graft versus host disease (SR-aGvHD), a high-mortality condition.
Mesoblast (Nasdaq:MESO) ha annunciato che i suoi prodotti cellulari allogenici, inclusi Ryoncil® e Revascor®, non saranno soggetti a dazi negli Stati Uniti poiché sono designati come prodotti di 'Origine Nazionale Statunitense'. I prodotti dell'azienda sono fabbricati da donatori statunitensi all'interno degli Stati Uniti.
Ryoncil® detiene la distinzione di essere l'unica terapia cellulare mesenchimale stromale allogenica approvata dalla FDA per qualsiasi indicazione. È specificamente approvata per il trattamento di pazienti pediatrici di 2 mesi e oltre con malattia acuta da rigetto contro l'ospite (SR-aGvHD) resistente agli steroidi, una condizione ad alta mortalità.
Mesoblast (Nasdaq:MESO) anunció que sus productos celulares alogénicos, incluidos Ryoncil® y Revascor®, no estarán sujetos a aranceles en EE. UU. ya que están designados como productos de 'País de Origen de EE. UU.'. Los productos de la empresa se fabrican a partir de donantes estadounidenses dentro de los Estados Unidos.
Ryoncil® tiene la distinción de ser la única terapia celular estromal mesenquimal alogénica aprobada por la FDA para cualquier indicación. Está específicamente aprobada para tratar a pacientes pediátricos de 2 meses en adelante con enfermedad injerto contra huésped aguda refractaria a esteroides (SR-aGvHD), una condición de alta mortalidad.
Mesoblast (Nasdaq:MESO)는 Ryoncil®과 Revascor®를 포함한 자가세포 제품이 '미국 원산지' 제품으로 지정되어 미국의 관세 적용을 받지 않게 될 것이라고 발표했습니다. 이 회사의 제품은 미국 내의 미국 기증자로부터 제조됩니다.
Ryoncil®은 어떤 적응증에 대해서도 FDA의 승인을 받은 유일한 동종 중간엽 줄기세포 치료제라는 차별성을 가지고 있습니다. 이는 스테로이드 내성 급성 이식편 대 숙주 질환(SR-aGvHD)으로 고통받는 2개월 이상의 소아 환자를 치료하는 데 특별히 승인되었습니다. 이 질환은 높은 사망률을 동반합니다.
Mesoblast (Nasdaq:MESO) a annoncé que ses produits cellulaires allogéniques, y compris Ryoncil® et Revascor®, ne seront pas soumis aux tarifs américains car ils sont désignés comme des produits d' 'Origine des États-Unis'. Les produits de l'entreprise sont fabriqués à partir de donneurs américains sur le sol américain.
Ryoncil® a la distinction d'être la seule thérapie cellulaire stromale mésenchymateuse allogénique approuvée par la FDA pour toute indication. Elle est spécifiquement approuvée pour traiter les patients pédiatriques âgés de 2 mois et plus atteints de maladie aiguë du greffon contre l'hôte réfractaire aux stéroïdes (SR-aGvHD), une condition à forte mortalité.
Mesoblast (Nasdaq:MESO) gab bekannt, dass ihre allogenen Zellprodukte, einschließlich Ryoncil® und Revascor®, nicht den US-Zöllen unterliegen, da sie als 'US-Herkunftsprodukte' eingestuft sind. Die Produkte des Unternehmens werden von US-Spendern innerhalb der Vereinigten Staaten hergestellt.
Ryoncil® hat die Auszeichnung, die einzige von der FDA genehmigte allogene mesenchymale Stammzelltherapie für jede Indikation zu sein. Es ist speziell für die Behandlung von pädiatrischen Patienten ab 2 Monaten mit steroid-refraktärer akuter Transplantat-gegen-Wirt-Krankheit (SR-aGvHD) zugelassen, einer Erkrankung mit hoher Sterblichkeit.
- Products exempt from U.S. tariffs due to U.S. Country of Origin designation
- FDA approval for Ryoncil as the only allogeneic mesenchymal stromal cell therapy
- None.
NEW YORK, April 03, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the status of its products in relation to the U.S. Government’s announcement on tariffs for imported products. Mesoblast believes that its allogeneic cellular products, including Ryoncil® and Revascor®, will not be subject to the tariffs.
Mesoblast develops allogeneic products based on its proprietary remestemcel-L and rexlemestrocel-L mesenchymal lineage stromal and precursor cell platform technologies. Its allogeneic cellular products derived from these platforms are manufactured from U.S. donors in the U.S. and designated as U.S. origin products.
Ryoncil® (remestemcel-L) is the only allogeneic mesenchymal stromal cell therapy approved by U.S. Food and Drug Administration (FDA) for any indication. 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. Ryoncil® is designated a ‘U.S. Country of Origin’ product as documented in the Company’s Biologic License Application (BLA), in line with US FDA and Customs regulatory guidance.
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) 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 X: @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 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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| Media – Global |
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| Emma Neal |
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| Media – Australia |
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| Steve Dabkowski |
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FAQ
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