Latest Graft Versus Host Disease News

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.

Cynata Therapeutics (ASX: CYP) has had its trading suspension lifted immediately following the publication of results from its Phase 3 Osteoarthritis and Phase 2 Graft versus Host Disease clinical trials.

Cynata Therapeutics secures a crucial regulatory green light from the EMA’s Paediatric Committee for its CYP-001 treatment in children with acute graft versus host disease, paving the way for sequential adult and paediatric trials in Europe.

Cynata Therapeutics has secured A$1.5 million through an institutional placement priced at a 22.5% discount, aiming to extend its cash runway ahead of pivotal Phase 3 and Phase 2 trial results expected in May and June 2026.

Cynata Therapeutics is on the cusp of releasing critical data from its Phase 2 aGvHD and Phase 3 osteoarthritis trials in Q2 2026, while managing a tight cash runway and preparing for a capital raising.

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.