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28.01.2026
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Ryoncil® Net Revenues Increase for the Quarter to US$30M
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Activity Report for Quarter Ended December 31, 2025 (Appendix 4C) Activity Report for Quarter Ended December 31, 2025 (Appendix 4C)...
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26.01.2026
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Real-World Commercial Experience with Ryoncil® Shows 84% Survival of Children with SR-aGvHD After Completing 28-Days of Treatment
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NEW YORK, Jan. 26, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on use of Ryoncil® (remestemcel-L-rknd) since commercially available in March 2025 for the approved label in children 2 months and older with steroid-refractory ac...
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19.01.2026
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FDA Acknowledges Effects on Pain Intensity Favor Rexlemestrocel-L, Confirms 12-Month Reduction in Back Pain Supports Product Efficacy
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Approval Label May Include Opioid Reduction Approval Label May Include Opioid Reduction...
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08.01.2026
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Ryoncil® Sales Increase 60% in December Quarter to US$35.1M
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Strong Balance Sheet Reflects Revenue Growth and New $125M Five-Year Facility Strong Balance Sheet Reflects Revenue Growth and New $125M Five-Year Facility...
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23.01.2026
© Globe Newswire
01.01.2026
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Mesoblast Announces Changes to Board of Directors' Leadership Roles
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NEW YORK, Jan. 01, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that as foreshadowed at the recent Annual General Meeting the Board will undertake a number of changes in line with the Company's evolution to a revenue-generating commerci...
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29.12.2025
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Mesoblast Retires Senior Debt with Non-Dilutive, Lower Cost, Five-Year Credit Line
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Mesoblast has option to draw down up to US$125 million by June 30, 2026...
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11.12.2025
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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
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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 h...
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03.12.2025
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Mesoblast Participation at Piper Sandler Conference
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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....
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24.11.2025
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Mesoblast Trading Update at Annual General Meeting Highlights Continued Strong Growth in Ryoncil® Revenue
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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....
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20.11.2025
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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
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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 i...
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17.11.2025
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James M. O’Brien Appointed Chief Financial Officer at Mesoblast
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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 (CF...
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04.11.2025
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Mesoblast to Meet With FDA Next Month to Discuss Rexlemestrocel-L and Opioid Cessation
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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 Ph...
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19.10.2025
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Ryoncil® Net Revenues Increase 69% in Second Quarter Post Launch
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Activity Report for Quarter Ended September 30, 2025 (Appendix 4C) Activity Report for Quarter Ended September 30, 2025 (Appendix 4C)...
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06.10.2025
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Ryoncil® Revenues Increase 66% in Second Quarter Post Launch
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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...
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03.10.2025
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Ryoncil® Receives J-Code From Medicare & Medicaid Services (CMS) Facilitating Reimbursement and Broader Patient Access
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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) b...
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26.09.2025
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Mesoblast Cell Therapy Products are Designated U.S. Origin and Not Subject to Tariffs
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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...
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15.09.2025
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Successful Commercial Launch of Ryoncil® Highlighted at Global Healthcare Conferences
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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 Administratio...
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04.09.2025
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Mesoblast Enters Into Option To Issue US$50 Million Convertible Notes
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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”)...
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29.08.2025
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Banner Year for Mesoblast With First FDA Product Approval and Successful Commercial Launch of Ryoncil®
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Financial Results and Operational Update for the Full Year Ended June 30, 2025 Financial Results and Operational Update for the Full Year Ended June 30, 2025...
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27.08.2025
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Mesoblast Financial Results and Corporate Update Webcast
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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....
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© Globe Newswire
18.07.2025
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Successful Commercial Launch of Ryoncil®
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Activity Report for Quarter Ended June 30, 2025 (Appendix 4C) Activity Report for Quarter Ended June 30, 2025 (Appendix 4C)...
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01.07.2025
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Mesoblast and FDA Align on Key Items for Revascor® Biologic License Application in Ischemic Heart Failure
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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 treat...
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12.06.2025
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Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD
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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 o...
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15.05.2025
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FDA Provides Seven Years of Orphan-Drug Exclusive Approval for Ryoncil®
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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 acut...
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© Globe Newswire
30.04.2025
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Appendix 4c Quarterly Activity Report for Quarter Ended March 31, 2025
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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....
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28.04.2025
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Mesoblast Appoints Corporate Finance Leader Lyn Cobley To Board
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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 positio...
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© Globe Newswire
17.04.2025
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Mesoblast Extends Payer Coverage For Ryoncil® to Over 100 Million US Lives
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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 approved by U.S. Food and Drug Administration (FDA) for any...
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© Globe Newswire
03.04.2025
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Mesoblast Allogeneic Cell Therapy Products Are Designated ‘U.S. Country of Origin’ and Not Subject to U.S. Tariffs
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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...
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© Globe Newswire
02.04.2025
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Mesoblast Files Request for Type B Meeting with FDA to Discuss Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure
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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 treatme...
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© Globe Newswire
30.03.2025
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First Three Children to Commence Treatment With Ryoncil®
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United States Centers for Medicare and Medicaid Services (CMS) Mandates Ryoncil® Coverage United States Centers for Medicare and Medicaid Services (CMS) Mandates Ryoncil® Coverage...
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27.03.2025
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Ryoncil® is Now Available for Purchase in the United States
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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 approved by U.S. Food and Drug Administration (FDA) for any indication, is now available for...
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© Globe Newswire
13.03.2025
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Ryoncil® Product Information Now Available in All Four Major Drug Pricing Compendia in United States
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NEW YORK, March 13, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that pricing information for Ryoncil® is now available in all four major drug pricing compendia in the United States. These pricing compendia provide the official source f...
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© Globe Newswire
06.03.2025
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Mesoblast Added to S&P/ASX 200 INDEX
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NEW YORK, March 06, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced its addition to the S&P Dow Jones Indices’ S&P/ASX 200 Index effective March 6, 2025 on the Australian Stock Exchange (ASX)....
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© Globe Newswire
26.02.2025
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Mesoblast Sets Ryoncil® Price Based on Economic Value of Treatment With Planned Product Availability This Quarter
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Financial Results and Operational Update for Half-Year Ended December 31, 2024 Financial Results and Operational Update for Half-Year Ended December 31, 2024...
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25.02.2025
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Mesoblast Financial Results and Corporate Update Webcast
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NEW YORK, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the half year ended December 31, 2024....
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23.02.2025
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Dr. Gregory George MD PhD Joins Mesoblast Board
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NEW YORK, Feb. 23, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has appointed Dr. Gregory George MD PhD, Mesoblast’s largest shareholder, to its Board of Directors....
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13.02.2025
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Ryoncil® FDA Approval and Market Launch Highlighted at Tandem Transplantation Meetings
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NEW YORK, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, today announced that its recently approved product Ryoncil® (remestemcel-L) is being highlighted at the 2025 Transplantation & Cellular Therapy Tandem Meetings of the American Societ...
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31.01.2025
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Ryoncil® Commercial Launch Update and Product Pipeline
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NEW YORK, Jan. 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the progress of the U.S. commercial launch of Ryoncil® (remestemcel-L) for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients 2...
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© Globe Newswire
30.01.2025
MESO
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Appendix 4C Quarterly Activity Report for Quarter Ended December 31, 2024
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NEW YORK, Jan. 30, 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 second quarter ended December 31, 2024....
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19.12.2024
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Mesoblast’s RYONCIL® is the First U.S. FDA-Approved Mesenchymal Stromal Cell (MSC) Therapy
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NEW YORK, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced the Food and Drug Administration (FDA) approved Ryoncil® (remestemcel-L) as the first mesenchymal stromal cell (MSC) therapy in the United States. RYONCIL is the only MSC t...
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© Globe Newswire
04.12.2024
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FDA Grants Revascor® (Rexlemestrocel-L) Regenerative Medicine Advanced Therapy (RMAT) Designation in Children with Congenital Heart Disease
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Earlier this year FDA granted REVASCOR both Rare Pediatric Disease Designation (RPDD) and Orphan-Drug Designation (ODD) for congenital heart disease Earlier this year FDA granted REVASCOR both Rare Pediatric Disease Designation (RPDD) and Orphan-Drug Designation (ODD) for congenital heart disease...
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© Globe Newswire
02.12.2024
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Revascor Improves Survival and Reduces Major Morbidity in High-Risk Ischemic Heart Failure Patients With Inflammation
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Phase 3 trial results published in European Journal of Heart Failure identify key target population for Mesoblast allogeneic cell therapy Phase 3 trial results published in European Journal of Heart Failure identify key target population for Mesoblast allogeneic cell therapy...
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© Globe Newswire
30.10.2024
MESO
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Appendix 4C Quarterly Activity Report for Quarter Ended September 30, 2024
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NEW YORK, Oct. 30, 2024 (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, 2024....
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© Globe Newswire
30.09.2024
MESO
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Mesoblast Option to Issue Up to US$50 Million Convertible Notes for Product Launch
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NEW YORK, Sept. 29, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced it has entered into a convertible note subscription agreement with its largest shareholder Gregory George (“Investor”) for issue, at its sole discretion, up to US$50.0 mil...
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© Globe Newswire
28.08.2024
MESO
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Mesoblast Reports Financial Results and Operational Update for Fiscal Year Ended June 30, 2024
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Potential first product approval and preparing for commercial launch Potential first product approval and preparing for commercial launch...
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27.08.2024
MESO
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Mesoblast Financial Results and Corporate Update Webcast
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NEW YORK, Aug. 27, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), 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, 2024....
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© Globe Newswire
31.07.2024
MESO
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Appendix 4C Quarterly Activity Report for Quarter Ended June 30, 2024
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Ryoncil BLA Submission Under FDA Review for Approval in Children with SR-aGVHD Ryoncil BLA Submission Under FDA Review for Approval in Children with SR-aGVHD...
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22.07.2024
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Patient Enrollment Commenced in Pivotal Phase 3 Trial of Rexlemestrocel-L for Chronic Low Back Pain
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NEW YORK, July 21, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that the confirmatory Phase 3 trial of its allogeneic, immunoselected, and industrially manufactured stromal cell product rexlemestrocel-L in patients with chronic low back...
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09.07.2024
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Mesoblast Resubmits Biologics License Application (BLA) with United States Food & Drug Administration (FDA) for Approval of Ryoncil® in Children with Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)
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NEW YORK, July 08, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today it has resubmitted its BLA for approval of Ryoncil® (remestemcel-L) in the treatment of children with SR-aGVHD....
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© Globe Newswire
03.06.2024
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Mesoblast Corporate Presentation at Investor Conference
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NEW YORK, June 02, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), Chief Executive Silviu Itescu provided a corporate update at the Bell Potter Emerging Leaders Conference....
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