Latest Cellular Medicine News

Mesoblast Limited is set to release its full-year financial results and operational highlights for 2025, spotlighting its FDA-approved cell therapy and expanding global partnerships.

Mesoblast has secured FDA agreement on key requirements for its Biologics License Application for Revascor, targeting ischemic heart failure patients with reduced ejection fraction. The company aims for accelerated approval by year-end 2025.

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.