Mesoblast reports positive FDA progress on accelerated approval for Revascor in ischemic heart failure and plans a pivotal trial to extend Ryoncil’s label to adults with graft versus host disease, while its US commercial launch outpaces expectations.
Mesoblast has been granted a seven-year orphan-drug exclusivity by the FDA for its cell therapy Ryoncil, reinforcing its market position in treating steroid-refractory acute graft versus host disease in children.
Mesoblast has raised A$260 million through a global private placement to fund the US commercial launch of its FDA-approved cell therapy Ryoncil® and accelerate clinical development in chronic low back pain.