Welcome to our dedicated page for Mesoblast news (Ticker: MESO), a resource for investors and traders seeking the latest updates and insights on Mesoblast stock.
Mesoblast Limited (NASDAQ: MESO; ASX: MSB) generates frequent news flow as it advances and commercializes allogeneic cellular medicines for severe inflammatory diseases. Company announcements highlight developments around its mesenchymal lineage cell therapy platform, led by Ryoncil (remestemcel-L-rknd) for pediatric steroid-refractory acute graft versus host disease (SR-aGvHD), as well as pipeline programs using remestemcel-L and rexlemestrocel-L.
News items commonly cover Ryoncil revenue trends, adoption across U.S. transplant centers, and reimbursement milestones such as assignment of a permanent HCPCS J-Code and expansion of coverage by commercial and government payers. Mesoblast also reports on trading updates, including quarterly activity reports that summarize revenue from cell therapy products and cash flow information released to the Australian Securities Exchange.
Investors following MESO news will see updates on clinical and regulatory progress, including pivotal trial plans for Ryoncil in adults with severe SR-aGvHD in collaboration with the NIH-funded Blood and Marrow Transplant Clinical Trials Network, and ongoing Phase 3 work with rexlemestrocel-L in chronic low back pain associated with degenerative disc disease. Company releases also discuss regulatory designations such as RMAT status for rexlemestrocel-L.
Corporate news includes financing arrangements like new credit facilities and convertible note programs, changes in board and executive roles, and participation in healthcare conferences. This news page aggregates Mesoblast’s press releases and related coverage so readers can review product performance, clinical milestones, capital structure updates, and governance developments in one place.
Mesoblast (MESO) has secured a significant regulatory milestone as the FDA granted seven years of orphan-drug exclusive approval for Ryoncil® (remestemcel-L), their treatment for steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients. The exclusivity prevents FDA approval of competing mesenchymal stromal or stem cell products for this indication until 2032.
Additionally, the company's biologic exclusivity extends until December 2036, preventing biosimilar competition. Mesoblast's intellectual property protection for SR-aGvHD treatments extends through 2044, creating a robust commercial barrier against competitors.
Mesoblast reported key developments for Q3 2025, highlighted by the successful US commercial launch of Ryoncil®, the first FDA-approved mesenchymal stromal cell therapy for acute GVHD in children. The company ended the quarter with a strong cash position of US$182 million.
Key operational highlights include:
- 15 Ryoncil® infusion kits sold since March 28 launch
- Coverage expanded to over 104 million US lives
- Ten priority transplant centers onboarded with MyMesoblast™ hub
- Nine key account managers deployed to accelerate center onboarding
The company is advancing other programs including Revascor® for chronic heart failure and rexlemestrocel-L for chronic low back pain. A global private placement raised A$260 million, strengthening their financial position. Mesoblast joined the S&P/ASX 200 Index in March 2025.
Mesoblast, a global leader in allogeneic cellular medicines, has appointed Lyn Cobley to its Board of Directors. Cobley brings over 30 years of financial services experience, having served as CEO of Westpac Institutional Bank and Group Treasurer of Commonwealth Bank of Australia.
The appointment follows Mesoblast's recent FDA approval of Ryoncil®. Cobley currently serves as a director of Commonwealth Bank of Australia and holds positions at Macquarie University Council and EXL APAC Advisory Council.
As an Independent Non-Executive Director, Cobley will contribute to Mesoblast's growth during key milestones, including commercialization expansion and development of treatments for highly prevalent diseases. Board Chair Jane Bell highlighted Cobley's extensive corporate finance and governance experience in regulated industries as valuable assets for the company's future.
Mesoblast (MESO) has expanded insurance coverage for its FDA-approved therapy Ryoncil® (remestemcel-L) to reach over 104 million US lives. The coverage includes both government and commercial payers.
The therapy, which is the first mesenchymal stromal cell (MSC) treatment approved by the FDA, has achieved significant coverage milestones:
- 37 out of 51 states now provide fee-for-service Medicaid coverage through Orphan Drug Lists or medical exception/prior authorization process, covering 20 million lives (80% of total Medicaid fee-for-service lives)
- Remaining states will implement mandatory coverage for 24 million lives by July 1, 2025
- Commercial plans and managed Medicaid have established policies covering 84 million lives
Additional coverage through Medical Exceptions policies exists but is not included in these figures, suggesting the total coverage is higher than reported.
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 (MESO) has filed a request for a Type B meeting with the FDA to discuss the accelerated approval pathway for Revascor® in treating ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation. The meeting, expected this quarter, will be held under Mesoblast's Regenerative Medicines Advanced Therapy (RMAT) designation.
In a previous Type B meeting, the FDA indicated Mesoblast's eligibility to file for accelerated approval for Revascor in end-stage HFrEF patients, based on data from two randomized controlled trials. The FDA also specified the requirement for a single confirmatory trial in class II/III patients with ischemic HFrEF and inflammation post-approval.
The upcoming meeting aims to obtain FDA feedback on chemistry, manufacturing & controls (CMC), align on potency assays for commercial product release, and discuss the proposed design and primary endpoint for the confirmatory trial.
Mesoblast (MESO) has entered into the Medicaid National Drug Rebate Agreement with U.S. Centers for Medicare & Medicaid Services for Ryoncil®, the first FDA-approved mesenchymal stromal cell therapy. This agreement ensures treatment access for approximately 40% of U.S. children covered by Medicaid who have steroid-refractory acute graft versus host disease (SR-aGvHD), with the remaining coverage through private insurance.
States can immediately opt to cover Ryoncil®, with mandatory coverage starting July 1, 2025. The first three children with SR-aGvHD will begin treatment this week. Ryoncil® is approved for pediatric patients 2 months and older, with a recommended course of 2×106 MSC/kg body weight per intravenous infusion, administered twice weekly for 4 consecutive weeks.
Mesoblast (MESO) has announced that Ryoncil® (remestemcel-L), the first FDA-approved mesenchymal stromal cell (MSC) therapy, is now commercially available in the United States. The therapy is approved for treating pediatric patients aged 2 months and older with steroid-refractory acute graft versus host disease (SR-aGvHD).
The recommended dosage is 2×106 MSC/kg body weight per intravenous infusion, administered twice weekly for 4 weeks. Mesoblast has established MyMesoblast™, a patient access hub, to facilitate insurance coverage and financial assistance. Nine commercial payers, covering approximately 37 million lives in the US, have published favorable medical policies. The company is also in process of entering the National Drug Rebate Agreement with Medicaid.
Mesoblast (Nasdaq:MESO; ASX:MSB) announced that pricing information for Ryoncil® is now accessible in all four major U.S. drug pricing compendia. This development follows the FDA's approval and publication of the revised Ryoncil® label, specifically updating Section 16 regarding supply and handling information.
The update includes the approval of eight new Ryoncil® kits, each with unique National Drug Codes (NDC), designed to match product dosage with patient weight-bands. Treatment centers can now order weight-appropriate kits with uniform pricing regardless of patient weight. The four major compendia are Merative Micromedex® RED BOOK®, First Databank FDB MedKnowledge® Drug Pricing, Elsevier Gold Standard Drug Database, and Wolters Kluwer Medi-Span® Price Rx®.