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) and inflammation, and label extension for Ryoncil® (remestemcel-L-rknd) in adu ...

Core Insights - Mesoblast Limited has successfully launched Ryoncil (remestemcel-L) for treating children with acute graft versus host disease (GVHD) shortly after receiving FDA approval, marking it as the first approved mesenchymal stromal cell therapy in the US [2][11] - The company is well-positioned financially, with a cash reserve of US$182 million (A$290 million), allowing for the expansion of Ryoncil's indications to other serious pediatric inflammatory diseases and adult acute GVHD [5][12] - Mesoblast is also preparing for a Type B meeting with the FDA to discuss the accelerated approval pathway for Revascor (rexlemestrocel-L) in treating ischemic chronic heart failure with reduced ejection fraction [5][12] Financial Highlights - The net operating cash spend for the quarter was US$12.7 million [5] - Cash on hand at the end of the quarter was US$182 million (A$290 million) [5] - Mesoblast raised A$260 million (US$161 million) through a global private placement primarily to existing major shareholders [12] Operational Highlights - Ryoncil became commercially available in the US on March 28, 2025, with Federal Medicaid coverage, and 15 infusion kits have been purchased for patient treatment [5] - The company has onboarded ten priority transplant centers, with plans to onboard an additional ten in the current quarter [5] - Mesoblast has expanded Ryoncil coverage to over 104 million US lives insured by commercial and government payers [5] Product Development - Ryoncil is being developed for additional indications, including adult SR-aGvHD and biologic-resistant inflammatory bowel disease [13] - Revascor is under development for chronic heart failure and has received RMAT designation from the FDA [12] - The confirmatory Phase 3 trial for rexlemestrocel-L in chronic low back pain is actively enrolling patients, with a focus on opioid cessation [12] Corporate Developments - Mesoblast has strengthened its Board of Directors with the appointment of Dr. Gregory George and Ms. Lyn Cobley [12] - The company was added to the S&P/ASX 200 Index effective March 6, 2025 [12] Intellectual Property - Mesoblast holds a strong global intellectual property portfolio with over 1,000 granted patents or applications covering its mesenchymal stromal cell technology [14] Manufacturing Capabilities - The company utilizes proprietary manufacturing processes to produce industrial-scale, cryopreserved, off-the-shelf cellular medicines [15] Company Overview - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory conditions, utilizing its proprietary mesenchymal lineage cell therapy technology [10]

Company Overview - Mesoblast is a global leader in developing allogeneic cellular medicines for severe inflammatory diseases, utilizing proprietary mesenchymal lineage cell therapy technology [4][6] - The company has received FDA approval for RYONCIL (remestemcel-L), the first mesenchymal stromal cell therapy for treating steroid-refractory acute graft versus host disease in pediatric patients [5][6] Recent Developments - Mesoblast appointed Lyn Cobley to its Board of Directors, who brings over 30 years of experience in the financial services industry, including senior roles at major banks [1][3] - Cobley expressed enthusiasm about Mesoblast's recent FDA approval and the company's potential for future growth, including commercialization and new indications for prevalent diseases [3] Strategic Initiatives - The company is focused on developing additional cell therapies for various indications, including adult SR-aGvHD and biologic-resistant inflammatory bowel disease, as well as rexlemestrocel-L for heart failure and chronic low back pain [6] - Mesoblast has established commercial partnerships in key markets such as Japan, Europe, and China [6] Intellectual Property and Manufacturing - Mesoblast holds a strong global intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection expected to last until at least 2041 in major markets [7] - The company utilizes proprietary manufacturing processes to produce industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability for patients worldwide [8]

Core Insights - Mesoblast has expanded coverage for its product Ryoncil® (remestemcel-L) to 104 million insured lives in the U.S. through government and commercial payers [1][2] - Ryoncil® is the first FDA-approved mesenchymal stromal cell therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged 2 months and older [4] Coverage Expansion - 37 out of 51 states provide fee-for-service Medicaid coverage for Ryoncil®, covering 20 million lives, which is 80% of total Medicaid fee-for-service lives [2] - Mandatory coverage for an additional 24 million lives will begin on July 1, 2025 [2] - Commercial plans cover 84 million lives, excluding medical exceptions policies, indicating that the actual commercial coverage is likely higher [2] Company Overview - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory conditions, utilizing a proprietary mesenchymal lineage cell therapy technology platform [3] - The company is also developing additional therapies for other inflammatory diseases and conditions such as heart failure and chronic low back pain [5] Intellectual Property - Mesoblast holds a strong global intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection expected to last until at least 2041 in major markets [6] Manufacturing Capabilities - The company has proprietary manufacturing processes that yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability to patients worldwide [7]