Mesoblast (MESO)

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Dr. Gregory George MD PhD Joins Mesoblast Board
Newsfilter· 2025-02-23 23:33
Core Insights - Mesoblast Limited has appointed Dr. Gregory George, its largest shareholder, to the Board of Directors, which is expected to enhance the company's operational efficiency as it transitions into a commercial organization [1][3]. Company Overview - Mesoblast is a global leader in developing allogeneic cellular medicines aimed at treating severe inflammatory diseases, utilizing its proprietary mesenchymal lineage cell therapy technology [4]. - The company has a strong 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]. Leadership and Expertise - Dr. Gregory George has a background as a medical scientist and founded the largest privately owned ambulatory surgical center company in the U.S., bringing valuable operational experience to Mesoblast [2][3]. - The CEO, Dr. Silviu Itescu, emphasized that Dr. George's operational skills will be crucial for Mesoblast's growth and efficiency [3]. Product Development - Mesoblast's RYONCIL® (remestemcel-L) is the first FDA-approved mesenchymal stromal cell therapy for treating steroid-refractory acute graft versus host disease in pediatric patients aged 2 months and older [5]. - The company is developing additional therapies for various inflammatory diseases and conditions, including heart failure and chronic low back pain, leveraging its allogeneic stromal cell technology platforms [6]. Manufacturing Capabilities - Mesoblast employs proprietary manufacturing processes that yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability to patients worldwide [8].
Ryoncil® Commercial Launch Update and Product Pipeline
Newsfilter· 2025-01-31 00:11
Core Insights - Mesoblast Limited is advancing the U.S. commercial launch of Ryoncil® (remestemcel-L) for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients aged 2 months and older, with a strong focus on ensuring product availability and successful launch this quarter [1][2][6] Company Mission - Mesoblast is dedicated to bringing innovative off-the-shelf allogeneic cellular medicines to market for the treatment of serious and life-threatening inflammatory illnesses [3] Market Opportunity - The annual market potential for steroid-refractory acute GvHD exceeds $1 billion, while heart failure with reduced ejection fraction (HFrEF) and chronic low back pain (CLBP) each have addressable market potentials exceeding $10 billion [5] - Ryoncil® is the only FDA-approved MSC therapy for any indication, specifically targeting pediatric SR-aGvHD, which is a life-threatening condition [5][15] Competitive Advantage - Mesoblast possesses a robust intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection expected to extend through at least 2041 in major markets [17] - The company has demonstrated a proven scientific approach, extensive positive clinical trial results, and the ability to meet regulatory requirements of the FDA [5][14] Financials and Projections - The successful financing of $160 million (A$260 million) has positioned the company with approximately $200 million (A$322 million) in cash on hand, supporting the U.S. launch activities and expansion of clinical indications for Ryoncil® [2][5] Upcoming Milestones - The U.S. launch of Ryoncil® is planned for this quarter, pending receipt of National Drug Codes (NDC) from the FDA [8] - Mesoblast will provide an update on half-year results on February 27, 2025 [2] - The company is also pursuing FDA accelerated approval for Revascor® in end-stage HFrEF and has commenced enrollment for a Phase 3 trial of rexlemestrocel-L for CLBP [10][13]
Appendix 4C Quarterly Activity Report for Quarter Ended December 31, 2024
Newsfilter· 2025-01-30 23:20
Core Insights - Mesoblast Limited has reported significant advancements in its operations and financials for the second quarter ended December 31, 2024, including the successful FDA approval of its therapy Ryoncil® for a critical condition in children [1][6]. Financial Summary - The company raised A$260 million (US$161 million) through a global private placement primarily targeting existing major shareholders [3]. - Net operating cash spend for the quarter was US$10.1 million, reflecting an 18% reduction (US$2.2 million) compared to the same quarter in FY2024 [7]. - Cash on hand at the end of the quarter was US$38 million (A$61 million), with pro-forma cash after the recent capital raise estimated at approximately US$200 million (A$322 million) [7]. Operational Highlights - Ryoncil® (remestemcel-L) became the first FDA-approved mesenchymal stromal cell therapy for children aged 2 months and older with steroid-refractory acute graft versus host disease (SR-aGvHD) [6][9]. - A distribution network has been established with Cencora to ensure efficient delivery of the therapy to U.S. treatment centers [6]. - The confirmatory Phase 3 trial for rexlemestrocel-L in chronic low back pain patients is actively enrolling, with plans to expand trial sites due to the recent capital raise [6]. - Mesoblast intends to meet with the FDA regarding accelerated approval for its therapy in end-stage heart failure patients under the Regenerative Medicine Advanced Therapy (RMAT) designation [6]. Research and Development - A publication in the European Journal of Heart Failure highlighted the positive outcomes of Revascor® (rexlemestrocel-L) in improving survival rates in high-risk patients with ischemic heart failure [6]. - The company is developing additional therapies for various inflammatory diseases and has established commercial partnerships in Japan, Europe, and China [10]. Intellectual Property and Manufacturing - Mesoblast holds a robust global intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection until at least 2041 in major markets [11]. - The company utilizes proprietary manufacturing processes to produce industrial-scale, cryopreserved cellular medicines, ensuring availability for patients worldwide [12].
MESO Stock Surges 80% in a Month After FDA Approval of GVHD Drug
ZACKS· 2025-01-03 17:00
Core Viewpoint - Mesoblast Limited (MESO) has experienced an 80% increase in share price within one month following FDA approval of remestemcel-L for treating steroid-refractory acute graft versus host disease (SR-aGVHD) in children aged two months and older, marking a significant milestone for the company as it launches its first approved product [1][2]. Company Summary - The FDA approval of remestemcel-L, branded as Ryoncil in the U.S., is expected to provide Mesoblast with a steady income stream as the company prepares for the product launch [2]. - Mesoblast's shares have surged 202.9% over the past six months, contrasting with a 4.8% decline in the industry [3]. - The approval was based on a phase III study where 70% of patients treated with remestemcel-L achieved an overall response by Day 28, indicating a positive prognosis for survival in aGVHD [4]. - No patients discontinued Ryoncil treatment due to laboratory abnormalities, with over 85% completing the full course without interruption [5]. Pipeline and Future Prospects - Mesoblast is exploring the expansion of Ryoncil's label to include adult patients with SR-aGVHD, with a late-stage study currently underway [6]. - The company is also evaluating Ryoncil for inflammatory bowel disease indications, including ulcerative colitis and Crohn's colitis [6]. - Another late-stage candidate, rexlemestrocel-L, is being developed for heart failure and chronic low back pain (CLBP), with FDA support for an accelerated approval pathway in patients with end-stage ischemic heart failure [9]. - Mesoblast initiated patient enrollment for a late-stage study of rexlemestrocel-L in CLBP, focusing on pain reduction and quality of life improvements [10].
MESO Stock Up as FDA Approves Ryoncil for Graft Versus Host Disease
ZACKS· 2024-12-19 19:21
Mesoblast Limited (MESO) announced that the FDA has approved Ryoncil (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in children aged two months and older, including adolescents and teenagers.Following the FDA nod, Ryoncil became the first and only mesenchymal stromal cell therapy to be approved for any indication in the United States.Ryoncil is also the first FDA-approved therapy for pediatric SR-aGvHD, a life-threatening condition with high mortality rate ...
Mesoblast's Cell Therapy Treatment For Graft Versus Host Disease Gets FDA Approval, Stock Surges
Benzinga· 2024-12-19 11:38
On Wednesday, the FDA approved Mesoblast Limited’s MESO Ryoncil (remestemcel-L) as the first mesenchymal stromal cell (MSC) therapy in the U.S.Ryoncil is the only MSC therapy approved in the U.S. for any indication and the only therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in children 2 months and older, including adolescents.Ryoncil contains MSCs, a type of cell that can have various roles in the body and can differentiate into multiple other types of cells. These MSCs are isola ...
Mesoblast's RYONCIL® is the First U.S. FDA-Approved Mesenchymal Stromal Cell (MSC) Therapy
Newsfilter· 2024-12-19 00:08
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 treatment wi ...
Mesoblast to be Added to Nasdaq Biotechnology Index
Newsfilter· 2024-12-18 12:30
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 accor ...
Revascor Improves Survival and Reduces Major Morbidity in High-Risk Ischemic Heart Failure Patients With Inflammation
GlobeNewswire News Room· 2024-12-02 23:20
NEW YORK, Dec. 02, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced a key publication in the November 2024 online issue of the prestigious peer-reviewed European Journal of Heart Failure (EJHF), which reports that a single intramyocardial injection of the Company’s allogeneic cell therapy Revascor® (rexlemestrocel-L) results in improved survival in high-risk patients with ischemic heart failure and in ...
Appendix 4C Quarterly Activity Report for Quarter Ended September 30, 2024
GlobeNewswire News Room· 2024-10-30 23:11
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. Mesoblast Chief Executive Silviu Itescu said: "We have had an extremely busy and productive quarter starting right from the outset with the filing of our Biologics License Application (BLA) with the United States Food and Drug Administration (FDA) for a ...