reports
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 Ltd: 1 director
A director at Mesoblast Ltd bought 500,000 shares at 1.044USD and the significance rating of the trade was 64/100. 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 clearly...
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...
Ryoncil® Product Information Now Available in All Four Major Drug Pric...
Ryoncil® Product Information Now Available in All Four Major Drug Pricing Compendia in United States 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 for all information required to order product, including product manufacturing details, National Drug Codes (NDC) for kit purchase, and kit pricing...
Mesoblast CEO to Deliver Featured Presentation at ISCT North America V...
Mesoblast CEO to Deliver Featured Presentation at ISCT North America Virtual Town Hall NEW YORK, March 12, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that Chief Executive Silviu Itescu will deliver the Featured Presentation at the International Cell & Gene Therapy (ISCT) North America Regional Virtual Town Hall at 4.00pm EDT, Wednesday, March 12th; 7.00am AEDT, Thursday, March 13th, 2025. The presentation, titled “Ryoncil® - The First FDA Approved Mesenchymal Stromal Cell The...
Mesoblast Added to S&P/ASX 200 INDEX
Mesoblast Added to S&P/ASX 200 INDEX 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). The S&P/ASX 200 is recognized as the institutional investable benchmark in Australia. Index constituents are drawn from eligible companies listed on the ASX. The S&P/ASX 200 is designed to measure the performance of the 200 largest index-eligible stoc...
Mesoblast Sets Ryoncil® Price Based on Economic Value of Treatment Wit...
Mesoblast Sets Ryoncil® Price Based on Economic Value of Treatment With Planned Product Availability This Quarter Financial Results and Operational Update for Half-Year Ended December 31, 2024 NEW YORK, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided financial results and an operational update for the period ended December 31, 2024, “Our FDA approved product Ryoncil® will be available in the coming weeks to the children with SR-aGvHD in need of life-saving therapy,” said...
Mesoblast Financial Results and Corporate Update Webcast
Mesoblast Financial Results and Corporate Update Webcast 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. The webcast will begin at 5.00pm EST, Wednesday, February 26th; 9.00am AEDT, Thursday, February 27th, 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 Compa...
Dr. Gregory George MD PhD Joins Mesoblast Board
Dr. Gregory George MD PhD Joins Mesoblast Board 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. Dr. George founded and managed the largest privately owned ambulatory surgical center company in the United States, SurgCenter Development. Dr. George brings to the Board his background as a medical scientist with unique operational experience having built a st...
Ryoncil® FDA Approval and Market Launch Highlighted at Tandem Transpla...
Ryoncil® FDA Approval and Market Launch Highlighted at Tandem Transplantation Meetings 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 Society for Transplantation and Cellular Therapy (ASTCT) and the Center for Blood and Marrow Transplant Research (CIBMTR), the industry’s premier conference taking place ...
Ryoncil® Commercial Launch Update and Product Pipeline
Ryoncil® Commercial Launch Update and Product Pipeline 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 months and older and key upcoming milestones for its late-stage pipeline. ”We are committed to making our FDA approved product Ryoncil® available as quickly as possible to the many c...
Appendix 4C Quarterly Activity Report for Quarter Ended December 31, 2...
Appendix 4C Quarterly Activity Report for Quarter Ended December 31, 2024 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. ACTIVITY REPORT On December 18, 2024, Ryoncil® (remestemcel-L) became the first mesenchymal stromal cell (MSC) therapy by U.S. FDA for any indication.FDA approved Ryoncil® as the first and only therapy for children aged 2 months and older, including ...
Mesoblast’s RYONCIL® is the First U.S. FDA-Approved Mesenchymal Stroma...
Mesoblast’s RYONCIL® is the First U.S. FDA-Approved Mesenchymal Stromal Cell (MSC) Therapy RYONCIL (remestemcel-L) is the first MSC product approved by FDA for any indication.RYONCIL is the first FDA-approved therapy for children aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft versus host disease (SR-aGvHD), a life-threatening condition with high mortality rates.In a single-arm, multi-center, Phase 3 trial of children with SR-aGvHD, 89% of whom had high severity Grade C or Grade D disease, 70% achieved an overall response by Day 28 of treatm...
Mesoblast to be Added to Nasdaq Biotechnology Index
Mesoblast to be Added to Nasdaq Biotechnology Index NEW YORK, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced its upcoming addition to the Nasdaq Biotechnology Index (Nasdaq: NBI) as part of the annual reconstitution of the 2024 Nasdaq index. Mesoblast’s inclusion in the NBI will be effective after the U.S. market opens on Monday, December 23, 2024. The Nasdaq Biotechnology Index contains securities of Nasdaq-listed companies classified according to the Industry Classif...
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