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 develops allogeneic cellular medicines for severe inflammatory conditions through a proprietary mesenchymal lineage cell therapy platform. Its commercial and pipeline updates center on Ryoncil® (remestemcel-L-rknd), an FDA-approved mesenchymal stromal cell therapy for pediatric steroid-refractory acute graft-versus-host disease, and on additional cell therapy programs for chronic low back pain, heart failure, Duchenne muscular dystrophy and inflammatory or autoimmune diseases.
Recurring company news covers Ryoncil launch and revenue trends, clinical and regulatory developments involving rexlemestrocel-L and Ryoncil label-extension programs, FDA clearances and designations, R&D presentations, technology licensing and platform expansion such as CAR-engineered MSC products, and quarterly cash-flow reporting filed with the Australian Securities Exchange.
Mesoblast Limited (Nasdaq:MESO) plans to host a webcast on August 26, 2020, at 6 PM EDT to present its financial and operational highlights for FY2020, ending June 30, 2020. The company focuses on developing allogeneic cellular medicines for inflammatory diseases and has received FDA priority review for RYONCIL™ to treat pediatric acute graft versus host disease, with a potential U.S. launch in 2020. Mesoblast is conducting Phase 3 trials for advanced heart failure and chronic low back pain and has commercial partnerships in Europe and China.
Mesoblast Limited (Nasdaq: MESO) announced that the FDA's Oncologic Drugs Advisory Committee voted in favor of remestemcel-L (RYONCIL™) for treating steroid-refractory acute graft versus host disease (SR-aGVHD) in children. Dr. Fred Grossman emphasized the critical need for approved therapies for this condition. The FDA has accepted the Biologics License Application for RYONCIL with a priority review, expected to conclude by September 30, 2020. If approved, Mesoblast plans to launch RYONCIL in the US within the year. Acute GVHD affects 50% of bone marrow transplant patients, with severe cases having a potential 90% mortality rate.
Mesoblast Limited (NASDAQ:MESO) announced an upcoming meeting of the FDA's Oncologic Drugs Advisory Committee (ODAC) on August 13, 2020, which will evaluate data supporting the Biologics License Application (BLA) for RYONCIL™ (remestemcel-L) aimed at treating steroid-refractory acute graft versus host disease (SR-aGVHD) in children. Currently, there are no FDA-approved therapies for this condition. The ODAC will review clinical trial results and vote on the efficacy of remestemcel-L, with a final FDA decision expected by September 30, 2020.