Mesoblast cell therapy Fast Track'd for COVID-19-related acute respiratory distress syndrome

 

• The FDA designates Mesoblast Limited's (NASDAQ:MESO) Phase 3-stage Ryoncil (remestemcel-L) for Fast Track review for the treatment of acute respiratory distress syndrome (ARDS) due to COVID-19.
• Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
• Remestemcel-L is an allogeneic mesenchymal stem cell product. It consists of culture-expanded mesenchymal stromal cells derived from the bone marrow of an unrelated donor. It is thought to have immunomodulatory properties to counteract the cytokine storms that are implicated in various inflammatory conditions by downregulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.
• https://seekingalpha.com/news/3640734-mesoblast-cell-therapy-fast-trackd-for-covidminus-19-related-acute-respiratory-distress