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) 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.