Mesoblast

What Mesoblast does

Mesoblast Limited is a commercial-stage biotechnology company founded in 2004 by physician scientist Silviu Itescu and dual-listed on the ASX (MSB) and NASDAQ (MESO). The company develops allogeneic (off-the-shelf) cellular medicines derived from a proprietary mesenchymal lineage cell (MLC) platform sourced from healthy adult donor bone marrow. These cells are expanded at industrial scale using proprietary media formulations and 2D/3D bioreactor technology, yielding cryopreserved cellular products that can be administered without donor-recipient matching or recipient immune suppression.

The company's commercial product is Ryoncil (remestemcel-L-rknd), the first FDA-approved mesenchymal stromal cell therapy for any indication, approved in December 2024 and commercially launched in April 2025 for pediatric steroid-refractory acute graft-versus-host disease (SR-aGvHD). Ryoncil generated approximately US$100 million in cumulative net revenues within its first year of launch, with Q3 FY2026 net revenues of US$30.3 million and full-year FY2026 guidance of US$110-120 million at 93% gross margin. The late-stage pipeline includes Revascor (rexlemestrocel-L) for chronic heart failure, MPC-06-ID for chronic discogenic low back pain, MPC-25-Osteo for spinal fusion, MPC-300-IV for biologic-refractory rheumatoid arthritis and diabetic nephropathy, and an expanding set of indications including adult SR-aGvHD and Duchenne muscular dystrophy.

Mesoblast monetizes through direct U.S. sales of Ryoncil to transplant centers, supplemented by licensing and royalty revenue from international partners including JCR Pharmaceuticals (Japan/TEMCELL), Grunenthal (Europe/Latin America), Tasly (China), and Takeda (Alofisel). In April 2026, the company acquired an exclusive worldwide license to a CAR technology platform from Mayo Clinic to engineer targeted MSC products for inflammatory and autoimmune diseases. The company operates from Melbourne, Australia with U.S. operations in New York and process development in Singapore, supported by a long-term manufacturing alliance with Lonza.

Name

Mesoblast

Legal name

Mesoblast Ltd.

Website

https://mesoblast.com

Company type

Public

Founded year

2004

Operating status

Operating

Headcount range

51–100 employees

Short description

Mesoblast is a commercial-stage biotech developing allogeneic off-the-shelf mesenchymal lineage cell therapies for severe inflammatory conditions. Its FDA-approved Ryoncil treats pediatric SR-aGvHD, with a late-stage pipeline targeting heart failure, chronic low back pain, and autoimmune diseases.

Ownership category

akta.pro rank

Product category

Regenerative Medicine Cellular Therapies

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Cell Therapy Developers (Allogeneic/Off-the-shelf) (HLAAABAB)

akta.pro secondary industries

Stem Cell Therapies (MSC/iPSC/HSC-derived) (HLAAABAE), Cell Therapy Enabling Technologies (gene editing, cell engineering, delivery methods) (HLAAABAL), Cell Therapy Manufacturing Services (GMP, autologous/allogeneic) (HLAAAKAC), Stem Cell–Based Regenerative Therapies (HLAAAGAA), Transplantation & Advanced Therapies Pharmaceuticals (incl. Cell & Gene Therapies) (HLAIAAAO)

Keywords

• Allogeneic cell therapy
• Regenerative medicine
• Mesenchymal stromal cells
• Cellular medicines
• Biologic therapeutics

Headquarters

HQ city

Melbourne

HQ country

Australia

HQ region

Oceania

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Ryoncil Product Sales: Commercial revenue from FDA-approved product Ryoncil (remestemcel-L-rknd) for pediatric SR-aGvHD. Launched April 2025, generating $48.7M net revenue in H1 FY2026 with 93% gross margin. Full-year FY2026 guidance of $110-120M net revenue.
2. Licensing and Royalty Revenue: JCR Pharmaceuticals in Japan receives royalties on TEMCELL sales; potential milestones from Grunenthal (Europe/Latin America MPC-06-ID), Tasly (China Revascor/MPC-25-IC), and Takeda (Alofisel) with up to €20M plus royalties.
3. CAR Technology Licensing: Mayo Clinic received shares as consideration for exclusive worldwide CAR technology license, with ongoing in-kind support including GMP manufacturing activities.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

Mesoblast develops, manufactures, and commercializes allogeneic (off-the-shelf) cellular medicines based on proprietary mesenchymal lineage cell (MLC) technology for severe and life-threatening inflammatory conditions. Its marketed product, Ryoncil (remestemcel-L-rknd), is the first FDA-approved mesenchymal stromal cell therapy, indicated for steroid-refractory acute graft-versus-host disease in pediatric patients and commercially launched in the United States in April 2025. The company also advances a late-stage pipeline including Revascor for chronic heart failure and MPC-06-ID for chronic discogenic low back pain.

Product overview

Mesoblast is a commercial-stage biotechnology company and world leader in developing allogeneic (off-the-shelf) cellular medicines for severe and life-threatening inflammatory conditions. The company's proprietary mesenchymal lineage cell technology platform yields industrial-scale, cryopreserved, off-the-shelf cellular medicines that can be administered without donor-recipient matching or recipient immune suppression. The marketed product portfolio centers on Ryoncil (remestemcel-L-rknd), the first FDA-approved mesenchymal stromal cell therapy for pediatric SR-aGvHD, launched commercially in April 2025. The late-stage pipeline includes Revascor (rexlemestrocel-L) for chronic heart failure, MPC-06-ID (rexlemestrocel-L) for chronic discogenic low back pain, MPC-300-IV for biologic-refractory rheumatoid arthritis and diabetic nephropathy, MPC-25-Osteo for spinal fusion, and MPC-25-IC for acute myocardial infarction. In April 2026, Mesoblast acquired an exclusive worldwide license to a CAR technology platform from Mayo Clinic to enhance targeted homing of its MSC products for autoimmune and inflammatory diseases.

Differentiator

Problem solved

Functional benefit

Brands

• Ryoncil: FDA-approved mesenchymal stromal cell therapy for steroid-refractory acute graft-versus-host disease in pediatric patients
• Revascor
• MPC-06-ID
• TEMCELL

Products and services

• Ryoncil (remestemcel-L-rknd) FDA-approved allogeneic mesenchymal stromal cell therapy indicated for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients 2 months of age and older; the first MSC product approved by the US FDA for any indication, administered intravenously at 2 x 10^6 MSCs/kg twice weekly for four consecutive weeks.
• Revascor (rexlemestrocel-L) Phase 3 product candidate consisting of 150 million mesenchymal precursor cells administered by direct injection into heart muscle for treatment of advanced and end-stage chronic heart failure, targeting cardiac inflammation to improve heart failure outcomes.
• MPC-06-ID (rexlemestrocel-L) Phase 3 product candidate consisting of 6 million mesenchymal precursor cells injected directly into damaged intervertebral discs for treatment of chronic low back pain caused by disc degeneration, targeting disc inflammation and aiming to restore disc function.
• MPC-25-Osteo Phase 3-ready product candidate consisting of 25 million mesenchymal precursor cells delivered on a collagen ceramic carrier material for lumbar spinal fusion procedures.
• MPC-25-IC Phase 2 product candidate for treatment of acute myocardial infarction via intracoronary infusion, delivered during angioplasty procedures to protect at-risk heart muscle cells from dying.
• MPC-300-IV Phase 2 product candidate comprising 300 million mesenchymal precursor cells delivered intravenously for treatment of biologic-refractory rheumatoid arthritis and diabetic nephropathy, targeting multiple inflammatory pathways simultaneously.
• remestemcel-L for Crohn's Disease Tier 2 product candidate consisting of 100-200 million mesenchymal stem cells delivered intravenously for treatment of Crohn's disease refractory to steroids and immunosuppressants, targeting T-cell mediated inflammatory responses.
• MPC-300-IV for Diabetic Nephropathy Phase 2 product candidate targeting diabetic kidney disease through intravenous delivery of up to 300 million mesenchymal precursor cells, addressing inflammatory pathways involved in renal complications of type 2 diabetes.

Quantifiable outcome

• Day-28 overall response rate of 66% (204/309 patients) in pediatric SR-aGvHD
• +5 more outcomes

Named customers1 record

Segments5 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Seven partnerships are on record, tiered core.

• JCR Pharmaceuticals Co. LtdcoreStrategic or Co-development Partner · 1 January 2018JCR has exclusive rights in Japan to Mesoblast's technology for hematologic malignancies using hematopoietic stem cell transplants. Received Japanese Government regulatory approval for TEMCELL HS Inj., the first allogeneic cell-based product to receive full approval in Japan. Expanded partnership in 2018 to cover wound healing in Epidermolysis Bullosa patients.
• Grunenthal GmbHcoreStrategic or Co-development PartnerStrategic partnership to develop and commercialize MPC-06-ID for chronic low back pain in Europe and Latin America. Companies agreed on development plan for European regulatory requirements, collaborating on Phase 3 trial design with results expected to support both FDA and EMA approvals.
• Tasly Pharmaceutical GroupcoreStrategic or Co-development PartnerTasly has rights in China to develop, manufacture and commercialize Revascor for chronic heart failure and MPC-25-IC for acute myocardial infarction. Parties plan to leverage each other's clinical trial results to expedite regulatory submissions.
• Lonza GroupcoreTechnology or IntegrationLong-term commercial manufacturing alliance providing capacity for global supply of proprietary product candidates. Access to Lonza's cell therapy facilities in Singapore, with potential for purpose-built facility to meet long-term commercial objectives.
• Mayo CliniccoreTechnology or IntegrationMesoblast acquired exclusive worldwide license to patented CAR technology platform from Mayo Clinic, published in Nature Biomedical Engineering. CAR technology enhances MSC products for targeted homing to inflamed tissue. Mayo Clinic provides in-kind support including GMP manufacturing activities.
• Blood and Marrow Transplant Clinical Trials Network (BMT CTN)coreStrategic or Co-development PartnerCollaborative partnership to initiate pivotal Phase 3 trial of Ryoncil for adults with severe acute GVHD refractory to corticosteroids. Enrollment expected to begin Q1 2026. Trial aims to extend Ryoncil from pediatric to adult indication.
• Parent Project Muscular DystrophycoreStrategic or Co-development PartnerPatient advocacy collaboration supporting Ryoncil registrational trial in Duchenne muscular dystrophy. Partnership includes patient identification and trial awareness support through the Duchenne Registry.

Scale indicators10 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Athersys: Athersys developed MultiStem, an allogeneic bone marrow-derived multipotent adult progenitor cell therapy targeting inflammatory conditions including GvHD and ischemic stroke. It is a direct allogeneic cell therapy peer to Mesoblast's Ryoncil platform, with comparable off-the-shelf manufacturing and similar target indications.
• Pluristem Therapeutics: Pluristem develops allogeneic placenta-derived mesenchymal-like adherent stromal cell therapies (PLX cells) for inflammatory and ischemic conditions. Direct cell therapy peer with shared allogeneic, off-the-shelf approach overlapping Mesoblast's indication strategy in GvHD and peripheral artery disease.
• JCR Pharmaceuticals: JCR Pharmaceuticals commercializes Mesoblast's remestemcel-L as TEMCELL HS Inj. in Japan for acute GvHD — the first allogeneic cell therapy fully approved in Japan. As Mesoblast's exclusive Japan licensee, JCR is both partner and direct commercial peer in the same MSC product.
• Bluebird Bio: Bluebird Bio develops gene and cell therapies for severe genetic diseases and oncology. Direct peer in commercial/clinical-stage advanced therapy with similar high-cost, single-administration pricing models and rare-disease commercialization playbook.
• Atara Biotherapeutics: Atara developed tabelecleucel, an allogeneic T-cell immunotherapy for Epstein-Barr virus-driven diseases including post-transplant lymphoproliferative disease, with overlap in the transplant/immunocompromised patient setting served by Ryoncil.

Emerging players

• Fate Therapeutics: Fate Therapeutics develops off-the-shelf iPSC-derived NK and T-cell immunotherapies primarily for oncology. Emerging player in the broader allogeneic cell therapy space with similar industrialization, GMP manufacturing, and pipeline-expansion approach but different modality (engineered immune cells vs. MSC).
• Adaptimmune Therapeutics: Adaptimmune develops engineered T-cell receptor (TCR) therapies for solid tumors. Emerging player in cell-based therapy commercialization with overlapping regulatory, manufacturing, and pricing considerations but different modality.
• CRISPR Therapeutics: CRISPR Therapeutics pioneered CRISPR/Cas9 gene-editing therapies (Casgevy, co-developed with Vertex) for sickle cell disease and beta-thalassemia. Emerging peer in the broader cell and gene therapy category with shared GMP manufacturing and regulatory pathway considerations.

Broad incumbents

• Takeda Pharmaceutical: Takeda acquired TiGenix and commercializes Alofisel, a competing allogeneic MSC therapy for complex perianal fistulas in Crohn's disease. As a major pharmaceutical incumbent and Mesoblast's licensor-counterparty on Alofisel royalties, Takeda is a broad incumbent peer in the cell therapy space.
• Vertex Pharmaceuticals: Vertex Pharmaceuticals is a broad incumbent in advanced therapies through its Casgevy partnership with CRISPR Therapeutics (first FDA-approved CRISPR gene therapy). While focused on gene editing rather than MSC, Vertex is a relevant commercial-stage advanced-therapy peer for capital allocation and pricing-power comparisons.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/mesoblast
• LinkedInlinkedin.com/company/mesoblast

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Subsidiaries1 record

Funding overview

Funding rounds11 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments1 record

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Mesoblast