Revascor (Rexlemestrocel-L) - (DREAM-HF)

June 30, 2026: Mesoblast Limited (ASX:MSB, NASDAQ:MESO) announced it has received an FDA Biologics License Application (BLA) filing number and has requested a modular review for rexlemestrocel-L to prevent life-threatening gastrointestinal bleeding due to right ventricular dysfunction in end-stage heart failure patients implanted with a left ventricular assist device (LVAD). The company noted rexlemestrocel-L has Orphan Drug Designation for prevention of life-threatening major mucosal bleeding events and RMAT designation for this LVAD patient population, which can enable rolling and priority review.

Mesoblast described rexlemestrocel-L as an investigational allogeneic mesenchymal precursor cell therapy intended to modulate inflammation in heart failure, and said it has been evaluated in two placebo-controlled randomized studies: a 565-patient trial in NYHA class II/III HFrEF and a 159-patient trial in end-stage HFrEF with LVAD. No efficacy or safety results or FDA action date were provided.