Mesoblast Receives BLA Filing Number and Requests Modular Review for Rexlemestrocel-L in Patients with End-Stage Heart Failure and LVADs

NEW YORK, June 30, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has received a Biologics License Application (BLA) filing number from the U.S. Food and Drug Administration (FDA) and has requested a modular review of its BLA for rexlemestrocel-L in prevention of life-threatening gastrointestinal bleeding due to right ventricular dysfunction in end-stage heart failure patients with a left ventricular assist device (LVAD). Rexlemestrocel-L has received Orphan Drug Designation for prevention of life-threatening major mucosal bleeding events and has Regenerative Medicine Advanced Therapy (RMAT) designation for this patient population, providing eligibility for rolling and priority reviews of the BLA.