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 (NASDAQ: MESO; ASX: MSB) generates frequent news flow as it advances and commercializes allogeneic cellular medicines for severe inflammatory diseases. Company announcements highlight developments around its mesenchymal lineage cell therapy platform, led by Ryoncil (remestemcel-L-rknd) for pediatric steroid-refractory acute graft versus host disease (SR-aGvHD), as well as pipeline programs using remestemcel-L and rexlemestrocel-L.
News items commonly cover Ryoncil revenue trends, adoption across U.S. transplant centers, and reimbursement milestones such as assignment of a permanent HCPCS J-Code and expansion of coverage by commercial and government payers. Mesoblast also reports on trading updates, including quarterly activity reports that summarize revenue from cell therapy products and cash flow information released to the Australian Securities Exchange.
Investors following MESO news will see updates on clinical and regulatory progress, including pivotal trial plans for Ryoncil in adults with severe SR-aGvHD in collaboration with the NIH-funded Blood and Marrow Transplant Clinical Trials Network, and ongoing Phase 3 work with rexlemestrocel-L in chronic low back pain associated with degenerative disc disease. Company releases also discuss regulatory designations such as RMAT status for rexlemestrocel-L.
Corporate news includes financing arrangements like new credit facilities and convertible note programs, changes in board and executive roles, and participation in healthcare conferences. This news page aggregates Mesoblast’s press releases and related coverage so readers can review product performance, clinical milestones, capital structure updates, and governance developments in one place.
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.