Latest Graft Versus Host Disease News

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.

Cynata Therapeutics confirms that the recent FDA orphan-drug exclusivity granted to Ryoncil® will not block approval of its CYP-001 therapy, highlighting key differences in drug composition and patient indications.

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 commercially launched Ryoncil in the US for pediatric acute GVHD, backed by a strong cash position and advancing multiple cell therapy programs.

A new peer-reviewed study highlights Cynata Therapeutics’ Cymerus™ iPSC-derived MSCs as superior to traditional donor tissue-derived MSCs in potency, consistency, and regenerative potential.

Mesoblast Limited is set to launch Ryoncil®, the first FDA-approved MSC therapy for pediatric steroid-refractory acute graft-versus-host disease, backed by a recent $160 million financing that strengthens its commercial and clinical development efforts.

Mesoblast has secured FDA approval for Ryoncil®, the first mesenchymal stromal cell therapy for steroid-refractory acute graft versus host disease in children, while raising A$260 million to accelerate clinical trials and commercial rollout.

Cynata Therapeutics reports encouraging Phase 1 results for its diabetic foot ulcer treatment CYP-006TK, alongside a strengthened balance sheet and ongoing clinical progress.

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.