Latest Ryoncil News

Mesoblast has secured FDA approval to add a new potency assay to commercial release and stability testing for Ryoncil, its approved cell therapy for paediatric graft-versus-host disease. The regulatory decision supports tighter monitoring as manufacturing processes evolve, but the company disclosed no direct financial impact or clinical outcome data.

Mesoblast has treated 350 patients in its pivotal Phase 3 trial for rexlemestrocel-L, targeting chronic low back pain linked to degenerative disc disease, setting the stage for top-line results in mid-2027.

Mesoblast delivered US$115 million in Ryoncil® revenue in its first full year post-FDA approval, while expanding clinical trials into adult indications and acquiring cutting-edge CAR technology to boost its cell therapy pipeline.

Mesoblast has completed treatment of 300 patients in its pivotal Phase 3 trial for rexlemestrocel-L, targeting chronic low back pain due to degenerative disc disease, with topline results expected mid-2027.

Mesoblast Limited’s Ryoncil® posted US$36 million in Q4 revenue, driving a full-year total of US$115 million, exceeding initial forecasts. The FDA-approved stem cell therapy for pediatric graft-versus-host disease shows robust uptake across US pediatric centres.

Mesoblast has received a Biologics License Application filing number from the FDA for rexlemestrocel-L, targeting life-threatening bleeding in end-stage heart failure patients with LVADs, advancing its regulatory journey with orphan drug and RMAT designations.

Mesoblast has drawn US$50 million from a new five-year facility that reduces its interest burden and retires expensive short-term debt, strengthening its financial position ahead of commercial expansion.

Mesoblast Limited posted US$30.3 million in net revenues for Ryoncil® in Q3 2026, hitting key clinical milestones and securing new technology licenses that could boost its next-generation cell therapies.

Mesoblast has acquired exclusive rights to a patented chimeric antigen receptor platform designed to enhance the targeting and potency of its mesenchymal stromal cell therapies, aiming to expand treatment options for inflammatory and autoimmune diseases.

Mesoblast Limited (ASX:MSB, Nasdaq:MESO) has received FDA Investigational New Drug clearance to initiate a pivotal clinical trial of its cell therapy Ryoncil in children with Duchenne Muscular Dystrophy, aiming to address inflammation-driven disease progression.

Mesoblast Limited (ASX:MSB, Nasdaq:MESO) reported net sales of US$30.3 million for its FDA-approved cellular therapy Ryoncil in the March quarter, bringing total revenue since launch close to US$100 million. Strong sales in February and March offset January’s seasonal dip.

Mesoblast Limited reported its first commercial sales of FDA-approved Ryoncil, generating $48.7 million in net product sales for the half-year ended December 31, 2025, while reducing its net loss by 16%. The company also secured a $125 million five-year credit facility, restructuring its debt to support ongoing commercialization and development.