Mostafa Rashidi Suja

Mesoblast Operational and Financial Highlights for Quarter Ended September 30, 2022

Retrieved on: 
Sunday, October 30, 2022

NEW YORK, Oct. 30, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the fourth quarter ended September 30, 2022.

Key Points: 
  • NEW YORK, Oct. 30, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the fourth quarter ended September 30, 2022.
  • The Company plans to have clearance from the FDA by year-end 2022 for the pivotal trial with primary endpoint 12-month reduction in pain.
  • Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets.
  • Mesoblast is developing product candidates for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms.

Mesoblast Submits New Information to FDA IND File in Response to Items in the CRL to the Remestemcel-L BLA for SR-aGVHD

Retrieved on: 
Monday, October 3, 2022

Remestemcel-L has been granted Fast Track Designation and BLA Priority Review from the FDA.

Key Points: 
  • Remestemcel-L has been granted Fast Track Designation and BLA Priority Review from the FDA.
  • The submission summarizes controlled data providing further evidence of remestemcel-Ls ability to save lives, said Dr. Silviu Itescu, Chief Executive of Mesoblast.
  • Mesoblast is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions.
  • Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets.