Mesoblast Ltd (MSB AU) got FDA approval for Ryoncil for steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older.
Following approval in pediatric patients, Mesoblast intends to commence a Phase 3 trial of Ryoncil in adults and adolescents, which has larger market size.
FDA approval enhances conviction on the commercial prospect of the other late-stage product candidates of the company, including Revascor for advanced chronic heart failure and rexlemestrocel-L for inflammatory pain indications.