reports
Ryoncil® Net Revenues Increase 69% in Second Quarter Post Launch
Ryoncil® Net Revenues Increase 69% in Second Quarter Post Launch Activity Report for Quarter Ended September 30, 2025 (Appendix 4C) NEW YORK, Oct. 19, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the first quarter ended September 30, 2025. Mesoblast Chief Executive Dr. Silviu Itescu said, “Revenues from sales of Ryoncil® continue to increase, driven by greater physician adoption with reimbursement from both commercial and government paye...
Ryoncil® Revenues Increase 66% in Second Quarter Post Launch
Ryoncil® Revenues Increase 66% in Second Quarter Post Launch 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$21.9 million on Ryoncil® (remestemcel-L-rknd) sales for the quarter ended September 30, 2025. This represents a 66% increase on the prior quarter ended June 30, 2025, with similar gross to net adjustment. Ryoncil® is the first mesenchymal stromal cell (MSC) product by the U.S. Food and Drug Administration (FDA) for any indication, and...
Ryoncil® Receives J-Code From Medicare & Medicaid Services (CMS) Facil...
Ryoncil® Receives J-Code From Medicare & Medicaid Services (CMS) Facilitating Reimbursement and Broader Patient Access NEW YORK, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that a specific Healthcare Common Procedure Coding System (HCPCS) J-Code assigned to Ryoncil® (remestemcel-L-rknd) by United States Medicare & Medicaid Services (CMS) became active for billing and reimbursement on October 1, 2025.1 Formal recognition by CMS is a significant milestone for Ryoncil® as...
Mesoblast Cell Therapy Products are Designated U.S. Origin and Not Sub...
Mesoblast Cell Therapy Products are Designated U.S. Origin and Not Subject to Tariffs NEW YORK, Sept. 26, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reiterated that its allogeneic cell therapy products are manufactured from U.S. donors in the U.S. and designated as U.S. origin products not subject to tariffs on imported branded or patented pharmaceutical products. Ryoncil® (remestemcel-L) is the only allogeneic mesenchymal stromal cell therapy by U.S. Food and Drug Administration (FDA...
Successful Commercial Launch of Ryoncil® Highlighted at Global Healthc...
Successful Commercial Launch of Ryoncil® Highlighted at Global Healthcare Conferences NEW YORK, Sept. 14, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced that the successful commercial launch of Ryoncil® (remestemcel-L-rknd), the only mesenchymal stromal cell (MSC) product approved by the United States Food and Drug Administration (FDA), was highlighted this past week in presentations at the Morgan Stanley and Cantor Fitzgerald Annual Global Healthcare Conferences held in New York. Me...
Mesoblast Ltd: 1 director
A director at Mesoblast Ltd bought 12,899,082 shares at 1.461USD and the significance rating of the trade was 68/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two years clea...
Mesoblast Enters Into Option To Issue US$50 Million Convertible Notes
Mesoblast Enters Into Option To Issue US$50 Million Convertible Notes NEW YORK, Sept. 03, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced it has entered into convertible note subscription agreements with SurgCenter principals and existing Mesoblast shareholders, Gregory George and William Gueck (“Investors”) to issue, at its sole discretion, up to US$50.0 million (A$76.8 million)1 of unsecured convertible notes. The funding is available at Mesoblast’s option, following shareholder ...
Banner Year for Mesoblast With First FDA Product Approval and Successf...
Banner Year for Mesoblast With First FDA Product Approval and Successful Commercial Launch of Ryoncil® Financial Results and Operational Update for the Full Year Ended June 30, 2025 NEW YORK, Aug. 28, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today provided financial results and an operational update for the period ended June 30, 2025. Mesoblast Chief Executive Dr. Silviu Itescu said, “This has been a banner year for the Company, with achievement of FDA approval for Ryoncil®, the first an...
Mesoblast Financial Results and Corporate Update Webcast
Mesoblast Financial Results and Corporate Update Webcast NEW YORK, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the full year ended June 30, 2025. The webcast will begin at 6.30pm EDT, Thursday, August 28; 8.30am AEST, Friday, August 29, 2025. It can be accessed via: The archived webcast will be available on the Investor page of the Company’s website: About Mesoblast Mesoblast (the Company) is a ...
Successful Commercial Launch of Ryoncil®
Successful Commercial Launch of Ryoncil® Activity Report for Quarter Ended June 30, 2025 (Appendix 4C) NEW YORK, July 17, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced gross revenue from sales of Ryoncil® (remestemcel-L-rknd) through the first quarter post product launch. Ryoncil® is the first and only FDA mesenchymal stromal cell (MSC) product in the Unites States and became commercially available for purchase on March 28, 2025, within one quarter of receiving F...
Mesoblast and FDA Align on Key Items for Revascor® Biologic License Ap...
Mesoblast and FDA Align on Key Items for Revascor® Biologic License Application in Ischemic Heart Failure NEW YORK, June 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced alignment with the United States Food and Drug Administration (FDA) on items required for filing a Biologics License Application (BLA) for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic heart failure with reduced ejection fraction (HFrEF) and inflammation. In follow-up to the successful Type B ...
Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway ...
Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD NEW YORK, June 11, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on continued momentum with United States Food and Drug Administration (FDA) regarding both accelerated approval pathway for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF...
FDA Provides Seven Years of Orphan-Drug Exclusive Approval for Ryoncil...
FDA Provides Seven Years of Orphan-Drug Exclusive Approval for Ryoncil® NEW YORK, May 14, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has received seven years of orphan-drug exclusive approval from U.S. Food and Drug Administration (FDA) for Ryoncil® (remestemcel-L) for treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older. This period of statutory exclusivity means that the FDA will not approve another m...
Appendix 4c Quarterly Activity Report for Quarter Ended March 31, 2025
Appendix 4c Quarterly Activity Report for Quarter Ended March 31, 2025 NEW YORK, April 29, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the third quarter ended March 31, 2025. “We were very pleased to have made Ryoncil® (remestemcel-L) commercially available to treat children with acute GVHD within one quarter of receiving FDA approval as the first mesenchymal stromal cell (MSC) therapy in the US for any indication,” said Dr. Silviu Itesc...
Mesoblast Appoints Corporate Finance Leader Lyn Cobley To Board
Mesoblast Appoints Corporate Finance Leader Lyn Cobley To Board NEW YORK, April 28, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has appointed Lyn Cobley to its Board of Directors. Ms. Cobley has been a global leader in the financial services industry with over 30 years’ experience in senior positions at international and domestic banks. Ms. Cobley has served as CEO of Westpac Institutional Bank, Group Treasurer of Commonwealth Bank of Australia, and held senior roles at Barclay...
Mesoblast Extends Payer Coverage For Ryoncil® to Over 100 Million US L...
Mesoblast Extends Payer Coverage For Ryoncil® to Over 100 Million US Lives NEW YORK, April 16, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has continued to expand coverage for Ryoncil® (remestemcel-L), the first mesenchymal stromal cell (MSC) therapy by U.S. Food and Drug Administration (FDA) for any indication, to 104 million US lives insured by government and commercial payers. To date, 37 of the 51 states provide fee-for-service Medicaid coverage for Ryoncil® through Orpha...
Mesoblast Allogeneic Cell Therapy Products Are Designated ‘U.S. Countr...
Mesoblast Allogeneic Cell Therapy Products Are Designated ‘U.S. Country of Origin’ and Not Subject to U.S. Tariffs 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 proprie...
Mesoblast Files Request for Type B Meeting with FDA to Discuss Acceler...
Mesoblast Files Request for Type B Meeting with FDA to Discuss Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure NEW YORK, April 02, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on its plans to meet with the United States Food and Drug Administration (FDA) to discuss the accelerated approval pathway for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation. Meso...
First Three Children to Commence Treatment With Ryoncil®
First Three Children to Commence Treatment With Ryoncil® United States Centers for Medicare and Medicaid Services (CMS) Mandates Ryoncil® Coverage NEW YORK, March 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has entered into the Medicaid National Drug Rebate Agreement (NDRA) with the U.S. Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, for Ryoncil® (remestemcel-L), the first mesenchymal stromal cell (MSC) therapy by U.S. Food and D...
Ryoncil® is Now Available for Purchase in the United States
Ryoncil® is Now Available for Purchase in the United States NEW YORK, March 26, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that Ryoncil® (remestemcel-L) the first mesenchymal stromal cell (MSC) therapy by U.S. Food and Drug Administration (FDA) for any indication, is now available for purchase in the United States. Ryoncil® is approved for treatment of pediatric patients 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft versus hos...
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