Mesoblast Limited
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- Mesoblast Limited (ASX:MSB; Nasdaq:MESO), a commercial-stage regenerative medicine company founded in 2004 and headquartered in Melbourne, Australia, develops and commercializes allogeneic cellular medicines derived from its proprietary mesenchymal lineage cell technology platform to treat complex inflammatory diseases with significant unmet needs; its lead products include Ryoncil (remestemcel-L), the first FDA-approved mesenchymal stromal cell therapy for steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients aged two months and older, Remestemcel-L for moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 and biologic-resistant inflammatory bowel disease, Revascor (rexlemestrocel-L or MPC-150-IM) for advanced chronic heart failure, MPC-06-ID for chronic low back pain due to degenerative disc disease, MPC-25-IC for ischemic stroke, and an emerging pipeline of next-generation stromal cell therapies. The company operates manufacturing facilities for industrial-scale production of off-the-shelf cells sourced from healthy adult bone marrow donors, conducts late-stage clinical trials across cardiovascular, orthopedic, hematologic, and respiratory indications, and maintains subsidiaries and commercial partnerships in the United States, Australia, Singapore, Japan, Europe, and China with licensees including JCR Pharmaceuticals, Tasly Pharmaceutical Group, and Grünenthal for regional distribution and development. Recent developments include FDA approval of Ryoncil in early 2025 followed by its successful U.S. commercial launch generating $11.3 million in net product sales through June 2025 with biologic exclusivity until December 2036, addition to the S&P/ASX 200 Index in March 2025, a July 2025 Type B meeting with the FDA to plan a pivotal trial in adults with SR-aGVHD conducted via the NIH-funded bone marrow transplant network, ongoing Phase 3 trials for Revascor in heart failure and MPC-06-ID in back pain, strategic alliances such as the 2022 global partnership with Novartis for MSC-100-IV inflammatory therapies, and a strengthened balance sheet with $161.6 million in cash reserves supporting pipeline expansion despite a $102.1 million FY2025 net loss from R&D investments, commercial buildup, and refinancing activities.
Mesoblast Reports Ryoncil® Net Revenues of US$30.3m and Improved Net Operating Cash Spend for the Quarter to US$4.1 Million
Mesoblast Reports Ryoncil® Net Revenues of US$30.3m and Improved Net Operating Cash Spend for the Quarter to US$4.1 Million
Mesoblast Achieves Patient Recruitment Target in Pivotal Phase 3 Trial for Chronic Low Back Pain
Mesoblast Acquires Chimeric Antigen Receptor (CAR) Platform Technology for Precision-Enhanced Cell Products
First Look: JPM beats, RVMD surges, NXST-TGNA paused
Gregory George Acquires 1,981,890 Shares of Mesoblast (NASDAQ:MESO) Stock
Gregory George Purchases 4,000,000 Shares of Mesoblast (NASDAQ:MESO) Stock
Gregory George Buys 2,324,072 Shares of Mesoblast (NASDAQ:MESO) Stock
Mesoblast Receives IND Clearance From FDA to Directly Proceed to Registrational Trial for Approval of Ryoncil® in Duchenne Muscular Dystrophy - CORRECTION
Mesoblast Limited (MESO) Discusses Cellular Medicine Platforms and Innovations at R&D Day Transcript
Why Mesoblast's Move Into DMD Warrants A Speculative Buy (Upgrade)
Mesoblast R&D Day Features Significant Commercial Progress & Platform Innovation
Mesoblast Receives IND Clearance from FDA to Directly Proceed to Registrational Trial for Approval of Ryoncil® in Duchenne Muscular Dystrophy
Ryoncil® Continues Successful First Year Launch with Net Sales of US$30.3M in March Quarter
Mesoblast to Host R&D Day on April 8, 2026
Dr. Teresa Montagut Appointed as Clinical Development and Medical Affairs Head at Mesoblast
Cell Therapies Moving From Lab to Factory Floor, and the Stocks Behind Them
Mesoblast (NASDAQ:MESO) Shares Gap Down – What’s Next?
Mesoblast Limited (MESO) Q2 2026 Earnings Call Transcript
Ryoncil® Profits Underpinning Substantial Growth Pipeline