隶属于 Mesoblast Ltd.
Mesoblast Ltd. is a biopharmaceutical company, which engages in the research, development, and market of mesenchymal lineage adult stem cell technology platform. Its medicines target cardiovascular diseases, spine orthopedic disorders, oncology and hematology, immune-mediated, and inflammatory diseases. The company was founded by Silviu Itescu on June 8, 2004 and is headquartered in Melbourne, Australia.
相关临床试验
38
17 进行中
药物批准
2
批准总数
监管机构
1
监管机构数
成立时间
2001
进行中（未招募）
15
39.5%
已完成
18
47.4%
No Longer Available
3
7.9%
尚未招募
2
5.3%
- DelveInsight's latest pipeline report reveals a robust heart failure therapeutic landscape with over 70 companies actively developing more than 75 pipeline drugs across various clinical stages. - Recent clinical trials include Boehringer Ingelheim's vicadrostat combination study, Novo Nordisk's CDR132L Phase 2 trial, and Help Therapeutics' stem cell therapy evaluation. - Leading pipeline therapies span multiple approaches including mesenchymal stem cells, controlled metabolic accelerators, and iPSC-derived cardiomyocytes from companies like Mesoblast, Rivus Pharmaceuticals, and Heartseed. - The pipeline encompasses treatments across all development stages from discovery to Phase III, with diverse mechanisms including gene therapy, small molecules, and regenerative medicine approaches.
- DelveInsight's 2025 pipeline analysis reveals a robust heart failure therapeutic landscape with over 70 companies developing 75+ pipeline therapies across various stages of clinical development. - Eli Lilly's tirzepatide demonstrated statistically significant improvements in both primary endpoints for heart failure with preserved ejection fraction and obesity in the Phase 3 SUMMIT trial. - Cytokinetics initiated patient enrollment for the Phase 3 COMET-HF confirmatory trial evaluating omecamtiv mecarbil, a novel cardiac myosin activator for symptomatic heart failure patients. - Leading pipeline candidates include Mesoblast's Rexlemestrocel-L in Phase III trials, Rivus Pharmaceuticals' HU 6 controlled metabolic accelerator, and Heartseed's iPSC-derived cardiomyocyte therapy HS-001.
- NextCell Pharma has appointed Dr. Eric Strati, former executive at Takeda, Mesoblast, and Novartis, to its Board of Advisors to advance commercial strategy for ProTrans, its type 1 diabetes cell therapy. - Dr. Strati brings critical expertise from launching two approved MSC-based therapies (Alofisel and Ryoncil), strengthening NextCell's capabilities as it prepares for pivotal trials and partnership opportunities. - Recent analysis from the ProTrans-Young study shows promising trends in preserving insulin production in patients aged 12-21 years, with full trial results expected in the second half of 2026.
- Mesoblast received US FDA orphan drug approval for Ryoncil, granting seven years of market exclusivity and driving a 15% share price increase over one week. - The approval significantly strengthens Mesoblast's competitive positioning, with expanded insurance coverage now reaching 104 million US lives. - Despite the regulatory milestone, Mesoblast remains unprofitable with A$47.93 million in net losses, though analysts forecast 56.7% annual revenue growth. - The company's shares still trade approximately 88% below consensus analyst price targets, suggesting potential for further market adjustments.
- The myocardial infarction therapeutics pipeline is robust, featuring over 45 companies developing more than 50 potential drugs. - Key companies like Boehringer Ingelheim and Idorsia Pharmaceuticals are advancing novel therapies to improve outcomes post-myocardial infarction. - Several promising therapies, including Selatogrel and FDY-5301, are in Phase III trials, showing potential for significant advancements. - Recent clinical trial activities, such as the commencement of the PERFECT study and completion of enrollment in the Iocyte AMI-3 trial, highlight ongoing research efforts.
• The FDA granted breakthrough therapy designation to STK-001 for Dravet syndrome, highlighting its potential to improve upon current treatments by restoring NaV1.1 protein levels. • Tolebrutinib received breakthrough therapy designation for non-relapsing secondary progressive multiple sclerosis based on phase 3 trial results showing delayed disability progression. • The FDA placed a clinical hold on PepGen’s PGN-EDO51 phase 2 study for Duchenne muscular dystrophy, pending further clarification from the agency.
• Mesoblast's mesenchymal stromal cell (MSC) therapy has gained FDA approval for steroid-refractory acute graft-versus-host disease (SR-aGVHD). • This approval marks a significant advancement in regenerative medicine, highlighting the potential of MSC therapies. • Pluri Inc. congratulates Mesoblast, emphasizing the importance of this milestone for the entire field of cellular medicine. • The FDA's decision underscores the opportunity to accelerate the development of MSC-based therapies globally, according to Pluri.
- The FDA has approved Ryoncil (remestemcel-L-rknd) as the first mesenchymal stromal cell (MSC) therapy for steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients. - Ryoncil's approval was based on a Phase III trial demonstrating a 70% overall response rate in children with SR-aGVHD after 28 days of treatment. - This allogeneic, bone marrow-derived MSC therapy offers a new treatment option for children with SR-aGVHD who do not respond to steroid treatment. - Ryoncil is administered intravenously and should be monitored for infusion reactions; common side effects include infections, fever, hemorrhage, and abdominal pain.
- Mesoblast's Ryoncil has been approved by the FDA for treating children with a severe blood disorder, marking a significant milestone for the company. - The FDA's decision led to a surge in Mesoblast's stock price, highlighting the market's positive response to the approval of this cell therapy. - Ryoncil represents a groundbreaking advancement in cell therapy, offering a new treatment option for a serious condition affecting pediatric patients. - This approval underscores the potential of cell-based therapies in addressing unmet medical needs in vulnerable populations.
- Several ASX-listed biotech companies are anticipating crucial Phase III clinical trial results in 2025, which could significantly impact their market value and future prospects. - Dimerix expects results from its ACTION3 Phase III trial of DMX-200 for focal segmental glomerulosclerosis (FSGS) by mid-2025, a rare kidney condition with no approved treatments. - Opthea anticipates Phase III trial results for sozinibercept (OPT-302) in combination with aflibercept or ranibizumab for wet age-related macular degeneration (wet-AMD) in 2025. - Recce Pharmaceuticals is set to commence a Phase III trial in Indonesia for RECCE 327 as a topical gel to treat diabetic foot infections (DFI) in early 2025.
