Mesoblast Ltd
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Mesoblast Ltd
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Mesoblast Ltd
Mesoblast is a biotechnology company that develops cell-based medicines, especially treatments made from donated adult stem cells. Its main work is to research, test, and seek approval for therapies aimed at hard-to-treat inflammatory and immune-related diseases, as well as some serious spine and heart conditions. The company does not sell a broad range of consumer products. It makes money when its drug candidates are licensed, approved, or commercialized through partners, and potentially through product sales and royalty streams tied to those therapies. Its customers are mainly hospitals, doctors, and larger pharmaceutical partners rather than end consumers. What makes Mesoblast different is that it sits in the cell-therapy part of drug development, where the product is living cells rather than a standard pill or injection. That makes the science, manufacturing, and regulatory path more complex than for many drugmakers, but it also gives the company a focused role as a specialist developer of regenerative medicines.
Mesoblast is a biotechnology company that develops cell-based medicines, especially treatments made from donated adult stem cells. Its main work is to research, test, and seek approval for therapies aimed at hard-to-treat inflammatory and immune-related diseases, as well as some serious spine and heart conditions.
The company does not sell a broad range of consumer products. It makes money when its drug candidates are licensed, approved, or commercialized through partners, and potentially through product sales and royalty streams tied to those therapies. Its customers are mainly hospitals, doctors, and larger pharmaceutical partners rather than end consumers.
What makes Mesoblast different is that it sits in the cell-therapy part of drug development, where the product is living cells rather than a standard pill or injection. That makes the science, manufacturing, and regulatory path more complex than for many drugmakers, but it also gives the company a focused role as a specialist developer of regenerative medicines.
Strong Launch: Ryoncil sales grew quarter-on-quarter after its April 2025 launch, reaching $49 million in net revenue for the first half of fiscal 2026.
Revenue Guidance: Mesoblast guided full-year fiscal 2026 Ryoncil net revenues to $110–120 million.
High Gross Margin: The company achieved a gross margin of around 93% for the period.
Cash & Credit: Mesoblast ended December 2025 with $130 million in cash and secured a new $125 million nondilutive credit facility.
Label Expansion: Active plans are underway to expand Ryoncil's label into adult indications, with clinical trials in progress.
Pipeline Progress: Key late-stage programs include Rexlemestrocel for chronic low back pain and Revascor for heart failure; BLA filings are planned in the near future.
Pediatric Adoption: Ryoncil is on track to achieve 20% market share in the pediatric segment by fiscal year-end, with notable repeat usage at treatment centers.
FDA Engagement: Management described constructive discussions with the FDA across multiple programs, including confirmation of pivotal trial endpoints.