Mesoblast Limited American Depositary Shares MESO

Mesoblast Ltd is a commercial-stage biotechnology company engaged in developing and commercializing allogeneic (off-the-shelf) cellular medicines for severe inflammatory conditions. Its commercial product, Ryoncil (remestemcel-L-rknd), is FDA-approved for steroid-refractory acute graft-versus-host disease in pediatric patients. The company is also developing Ryoncil for additional inflammatory indications. Its rexlemestrocel-L platform is being developed for chronic low back pain associated with degenerative disc disease and chronic heart failure. The company operates as a single segment focused on its allogeneic cellular medicines platform.

MESO hizo una agrupación de acciones (split inverso) de 1:2 el 10 de enero de 2024: cada 2 acciones se juntaron en una. Bajó la cantidad de acciones y subió su precio, pero no el valor total de la inversión.

• GlobeNewswire Inc. 26 ago

  Mesoblast Reports Substantial Revenue Growth to US$120M

  Mesoblast Limited reported strong financial results for FY2026 with total revenue of US$120.3 million, driven by successful RYONCIL commercial launch generating US$115.2 million in net revenue. The company completed patient treatment in its Phase 3 trial for chronic low back pain (rexlemestrocel-L), with results expected mid-2027. Net losses were reduced 44% to US$57.5 million. The company is expanding RYONCIL into adult markets and developing next-generation CAR-MSC and oncolytic virus technologies.

  

• GlobeNewswire Inc. 29 jul

  Mesoblast Reports Ryoncil® Net Revenues of US$36M for the Quarter and US$115M for First Full Year of Product Launch

  Mesoblast Limited reported strong first-year commercial performance for Ryoncil® with Q4 net revenues of US$36M and full-year revenues of US$115M following FDA approval. The company is expanding Ryoncil® indications to adults with steroid-refractory acute GvHD and children with Duchenne muscular dystrophy. Additionally, Mesoblast achieved its target of 300 patients treated in the pivotal Phase 3 trial for rexlemestrocel-L in chronic low back pain and received FDA clearance for a registrational trial in adults with SR-aGvHD.

  

• GlobeNewswire Inc. 13 jul

  Mesoblast Achieves Target of 300 Treated Patients in Pivotal Phase 3 Trial for Chronic Low Back Pain

  Mesoblast Limited announced it has enrolled 300 patients in its MSB-DR004 Phase 3 pivotal trial for rexlemestrocel-L, a cellular medicine for chronic low back pain associated with degenerative disc disease. The trial aims to confirm pain reduction benefits seen in earlier trials, with top-line results expected in mid-2027. The company is proceeding with commercial manufacturing in parallel with the trial, targeting potential peak year revenue exceeding US$10 billion.

  

• GlobeNewswire Inc. 9 jul

  Ryoncil® Delivers Net Revenue of US$36M for the Fourth Quarter Ended 30 June 2026

  Mesoblast Limited announced Ryoncil net revenue of US$36 million for Q4 and US$115 million for fiscal year 2026, exceeding initial projections. The FDA-approved mesenchymal stromal cell therapy for pediatric steroid-refractory acute graft-versus-host disease is showing strong uptake across major U.S. pediatric centers. The company maintains a strong capital position with a new five-year facility supporting continued revenue growth and pipeline development.

  

• GlobeNewswire Inc. 30 jun

  Mesoblast Receives BLA Filing Number and Requests Modular Review for Rexlemestrocel-L in Patients with End-Stage Heart Failure and LVADs

  Mesoblast Limited announced it received a Biologics License Application (BLA) filing number from the FDA and requested modular review for rexlemestrocel-L, a cellular therapy for preventing life-threatening gastrointestinal bleeding in end-stage heart failure patients with left ventricular assist devices. The therapy has received Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation, enabling rolling and priority reviews. The announcement comes as the FDA released new guidance supporting regulatory flexibility for orphan rare diseases with high mortality.