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Mesoblast Limited (ASX: MSB; NASDAQ: MESO) is a leading biotechnology company specializing in innovative cell-based medicines. Leveraging its proprietary mesenchymal lineage adult stem cells (MLCs) technology, Mesoblast has established a robust portfolio of advanced cellular medicines. These 'off-the-shelf' allogeneic products use cells from a single donor to treat multiple recipients, eliminating the need for cell matching.
In Japan, Mesoblast's licensee has launched an MLC-based product for acute graft versus host disease (aGVHD) in both children and adults. This marks the first fully approved allogeneic cell-based product in Japan. In the United States, Mesoblast is poised to have its first industrially manufactured allogeneic cell-based product approved.
Mesoblast's lead product candidates include MPC-150-IM for chronic heart failure, MPC-06-ID for chronic low back pain due to disc degeneration, and MSC-100-IV for acute graft versus host disease. The company's pipeline also features remestemcel-L for steroid-refractory aGVHD, moderate to severe acute respiratory distress syndrome (ARDS), and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for advanced chronic heart failure and chronic low back pain.
Mesoblast boasts a strong global intellectual property portfolio, ensuring protection until at least 2041 in major markets. The company's proprietary manufacturing processes produce industrial-scale, cryopreserved, off-the-shelf cellular medicines, intended to be readily available worldwide. Two of its products have already been commercialized in Japan and Europe by its licensees.
Headquartered in Australia, with locations in the United States and Singapore, Mesoblast is listed on the Australian Securities Exchange and NASDAQ. For more information, visit the official website at www.mesoblast.com.
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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