reports
Independent Study Presented at American Society of Hematology (ASH) An...
Independent Study Presented at American Society of Hematology (ASH) Annual Meeting Concludes Remestemcel-L Superior to Ruxolitinib in Clinical Outcomes as Treatment for SR-aGvHD NEW YORK, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that an independent peer-reviewed comparative analysis of efficacy and safety between remestemcel-L and ruxolitinib for treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) was presented at the 67th ASH Annual meeting i...
Mesoblast Participation at Piper Sandler Conference
Mesoblast Participation at Piper Sandler Conference NEW YORK, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced its participation at the Piper Sandler 37th Annual Healthcare Conference in New York on December 2–4, 2025. Silviu Itescu, Chief Executive of Mesoblast, is scheduled for a fireside chat at 12.00 p.m. ET on Thursday, December 4, 2025. A live webcast of the event will be available using this weblink . A replay of the webcast will be available following the completi...
Mesoblast Trading Update at Annual General Meeting Highlights Continue...
Mesoblast Trading Update at Annual General Meeting Highlights Continued Strong Growth in Ryoncil® Revenue NEW YORK, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided a trading update, together with a comprehensive operational overview, as part of the Chief Executive’s Annual General Meeting (AGM) address. For the quarter ending December 31, 2025, management expects gross revenue of more than US$30.0 million from sales of Ryoncil® (remestemcel-L-rknd). This represents more th...
Mesoblast and BMT CTN to Initiate Pivotal Trial of Ryoncil® as Part of...
Mesoblast and BMT CTN to Initiate Pivotal Trial of Ryoncil® as Part of First-Line Regimen in Adults with Severe Acute GVHD Refractory to Steroids NEW YORK, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that given the high rate of non-responsiveness to therapies in adults with severe acute graft versus host disease (aGvHD) who fail corticosteroids, and the high mortality in these patients, Mesoblast and the United States National Institutes of Health (NIH)-funded Blood an...
James M. O’Brien Appointed Chief Financial Officer at Mesoblast
James M. O’Brien Appointed Chief Financial Officer at Mesoblast NEW YORK, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that in connection with the Company’s transition to a fully integrated commercial organization it has appointed James M. O’Brien as its US-based Chief Financial Officer (CFO). Jim has extensive experience in all aspects of financial management and planning having spent the majority of his career with multi-national public and private companies in the li...
Mesoblast to Meet With FDA Next Month to Discuss Rexlemestrocel-L and ...
Mesoblast to Meet With FDA Next Month to Discuss Rexlemestrocel-L and Opioid Cessation NEW YORK, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the U.S. Food & Drug Administration (FDA) has scheduled a meeting in early December to discuss Mesoblast's data on opioid reduction and cessation from its first Phase 3 study (MSB-DR003) of rexlemestrocel-L in patients with chronic low back pain (CLBP). In Mesoblast's first randomized controlled Phase 3 trial of 404 patients...
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...
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