Mesoblast

aka Mesoblast, Inc., Mesoblast Limited

Mesoblast is an Australian cell therapy company whose remestemcel-L became in December 2024 the first mesenchymal stromal cell therapy approved by the FDA, for children with steroid-refractory acute graft-versus-host disease.

Mesoblast, headquartered in Melbourne with a US base in New York, develops allogeneic mesenchymal stromal cell therapies from healthy donor bone marrow. After a long regulatory path including an earlier complete response letter, its product remestemcel-L (Ryoncil) was approved by the FDA in December 2024 for steroid-refractory acute graft-versus-host disease in children aged two months and older, a complication of stem cell transplantation for blood cancers. The company is also developing the platform for heart failure and back pain. Company facts are from FDA approval records.

Headquarters

Melbourne, AU

Scorecard

All companies

#210of 779 companies, score 9

approved products +6
modalities +2
regions +1

1 approved, 0 in phase 3, 0 earlier, 0 targets, 0 registry studies. Formula on the scorecards page.

Type

cell therapy

Stage

Public

Products

1top

ApprovedAllogeneic bone marrow-derived mesenchymal stromal cell therapy

Remestemcel-L · Ryoncil

Donor bone marrow stromal cells given to children whose acute graft-versus-host disease no longer responds to steroids, the first mesenchymal stromal cell therapy approved in the United States.