Welcome to our dedicated page for Mesoblast news (Ticker: MESO), a resource for investors and traders seeking the latest updates and insights on Mesoblast stock.
Mesoblast Limited (MESO) is a global leader in developing innovative allogeneic cellular medicines for inflammatory diseases and degenerative conditions. This page provides investors and industry stakeholders with timely updates on clinical advancements, regulatory decisions, and strategic developments shaping the company's trajectory in regenerative medicine.
Access consolidated updates on Mesoblast's pipeline progress, including late-stage trial results for chronic heart failure therapies and manufacturing expansions. Track critical milestones like FDA submissions and international partnership announcements alongside earnings reports and peer-reviewed research publications.
Our news collection serves as a definitive resource for understanding Mesoblast's position in cellular therapeutics, featuring verified updates on:
- Regulatory progress for product candidates across global markets
- Clinical trial outcomes in inflammatory and cardiovascular diseases
- Strategic collaborations with pharmaceutical partners and research institutions
- Manufacturing innovations enabling scalable production of off-the-shelf therapies
Bookmark this page for streamlined monitoring of Mesoblast's advancements in mesenchymal lineage cell technologies and their impact on patient care standards.
Mesoblast Limited (NASDAQ:MESO; ASX:MSB) has successfully completed a global private placement, raising approximately US$40 million at A$0.85 per share, primarily from existing major shareholders in the US, UK, and Australia. The funds will support the commercialization of remestemcel-L for treating children with steroid-refractory acute graft versus host disease (SR-aGVHD), pending FDA approval, with a PDUFA goal date set for August 2, 2023. Additionally, proceeds will aid in the ongoing manufacturing of this product and the initiation of a Phase 3 clinical trial for rexlemestrocel-L aimed at chronic low back pain. CEO Dr. Silviu Itescu emphasized the company's commitment to bringing innovative treatments to market and acknowledged the strong support from major shareholders.
Mesoblast Limited (Nasdaq: MESO) announced the FDA's ongoing review of its Biologics License Application (BLA) resubmission for remestemcel-L, targeting pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD). The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 2, 2023, and scheduled a Pre-License Inspection of the company’s manufacturing facility in Singapore. If approved, remestemcel-L will be the first allogeneic, off-the-shelf therapy for children under 12 with SR-aGVHD, addressing a significant unmet need. The therapy has shown promising survival data in clinical trials.
Mesoblast Limited (Nasdaq: MESO) announced the FDA has accepted their resubmission of the Biologics License Application for remestemcel-L, a therapy for children with steroid-refractory acute graft versus host disease (SR-aGVHD). The FDA set a PDUFA goal date of August 2, 2023. If approved, remestemcel-L will be the first allogeneic 'off-the-shelf' medicine in the US and the first therapy for children under 12 with SR-aGVHD. The resubmission includes new long-term survival data and manufacturing improvements. The FDA has granted fast track and priority review designations for the therapy, highlighting the urgent need for effective treatments for SR-aGVHD.
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