At long last, Mesoblast's RYONCIL has been approved by the FDA. Shares jumped 54% to close at $3.05.
"RYONCIL is the first FDA-approved therapy for children aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft versus host disease (SRaGvHD), a life-threatening condition with high mortality rates.
What is RYONCIL (remestemcel-L)
RYONCIL is an allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older."
I am glad that $MSB have finally been able to get one of their treatments across the line with the FDA. Congratulations. I wonder how this will play out moving forward.