Welcome to our dedicated page for Mesoblast American Depositary Shares news (Ticker: MESO), a resource for investors and traders seeking the latest updates and insights on Mesoblast American Depositary Shares stock.
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 (Nasdaq:MESO; ASX:MSB) has commenced enrollment for its confirmatory Phase 3 trial of rexlemestrocel-L in patients with chronic low back pain (CLBP) due to inflammatory degenerative disc disease. The trial, aligned with FDA guidelines, involves 300 patients across multiple U.S. sites. The primary endpoint is pain reduction at 12 months, with secondary measures including improved quality of life, function, and reduced opioid usage.
The FDA has granted rexlemestrocel-L Regenerative Medicine Advanced Therapy (RMAT) designation, providing benefits such as rolling review and priority review eligibility. Dr. Alan Miller, a trial investigator, describes the therapy as potentially groundbreaking for the low back pain population.
Mesoblast (Nasdaq: MESO) has resubmitted its Biologics License Application (BLA) to the FDA for Ryoncil® (remestemcel-L), targeting treatment for children with Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD).
This follows FDA guidance that recent Phase 3 clinical data supports the application. The BLA addresses Chemistry, Manufacturing, and Control (CMC) issues.
Ryoncil® has been granted Fast Track and Priority Review designations, indicating its potential to significantly improve outcomes for children with this serious condition. Approval is expected between two to six months from resubmission.
Mesoblast (Nasdaq:MESO; ASX:MSB) announced that it will file a Biologics License Application (BLA) for its product, Ryoncil® (remestemcel-L), next week. The application seeks FDA approval to use Ryoncil® for treating children with steroid-refractory acute graft versus host disease (SR-aGVHD). If approved, this could position Mesoblast as a key player in treating pediatric inflammatory diseases, opening potential new revenue streams and solidifying its leadership in allogeneic cellular medicines.
Mesoblast (Nasdaq:MESO; ASX:MSB) presented a corporate update at the Bell Potter Emerging Leaders Conference. CEO Silviu Itescu announced that the company plans to resubmit its Biologics License Application (BLA) for Ryoncil® (remestemcel-L) for treating steroid-refractory acute graft versus host disease to the FDA this quarter, with potential approval expected in the second half of 2024. The company is also advancing Phase 3 trials for heart failure and back pain treatments, with accelerated approval pathways from the FDA for the heart failure product Revascor® (rexlemestrocel). Mesoblast has a strong intellectual property position in the U.S., with patents covering mesenchymal stem cell compositions that could extend up to 2043, providing a significant commercial advantage.
Mesoblast provided an activity report for the third quarter ended March 31, 2024, highlighting FDA clarity on licensure for remestemcel-L and rexlemestrocel-L. The FDA supports an accelerated approval pathway for rexlemestrocel-L in end-stage heart failure and remestemcel-L in pediatric graft versus host disease. Financially, Mesoblast strengthened its balance sheet, reduced debt, and implemented cost containment strategies.
FAQ
What is the current stock price of Mesoblast American Depositary Shares (MESO)?
What is the market cap of Mesoblast American Depositary Shares (MESO)?
What is Mesoblast Limited's core business?
What are the key product candidates of Mesoblast?
What is unique about Mesoblast's products?
Has Mesoblast commercialized any products?
What recent achievements has Mesoblast made?
Where is Mesoblast Limited headquartered?
How can I stay updated with Mesoblast's latest news?
What is the significance of Mesoblast's intellectual property portfolio?
What are Mesoblast's main areas of research and development?
What makes Mesoblast’s manufacturing process unique?
