Mesoblast (MESO) said late Wednesday the US Food and Drug Administration has approved its mesenchymal stromal cell therapy Ryoncil for steroid-refractory acute graft versus host disease in children 2 months and older, adolescents and teenagers.
Shares of Mesoblast surged 51% in premarket activity Thursday.
The company said Ryoncil is the first FDA-approved treatment for the condition, which often occurs after stem-cell transplants and can cause organ damage.
The approval followed the results of a phase 3 trial in children with the condition which achieved a 70% overall response rate after 28 days of treatment with Ryoncil, the company said.
Ryoncil will be available in the US at transplant centers and hospitals, the company said.
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