ASX:MSBBiotechs
Why Mesoblast (ASX:MSB) Is Up 9.3% After FDA Accepts Modular BLA Review For Rexlemestrocel-L
In late June 2026, Mesoblast received a Biologics License Application filing number from the U.S. FDA and requested modular review for rexlemestrocel-L to prevent life-threatening gastrointestinal bleeding in end-stage heart failure patients supported by left ventricular assist devices, building on its Orphan Drug and RMAT designations.
The filing comes as new FDA draft guidance reiterates a flexible approach to therapies for rare, high-mortality conditions, potentially aligning closely with...