Recent Updates — MESO

Mesoblast Limited announced on September 24, 2026, that it received approval from the United States Food and Drug Administration (FDA) to implement a new potency assay, T-cell Proliferation Inhibition BioAssay (TIBA), for release and stability monitoring of commercial lots of its FDA-approved mesenchymal stromal cell product Ryoncil. This assay will be used in conjunction with existing assays to ensure the consistency and clinical effectiveness of Ryoncil, which is approved for steroid-refractory acute graft versus host disease in pediatric patients aged 2 months or older. Mesoblast Limited operates as a global leader in developing allogeneic cellular medicines for inflammatory diseases.

Mesoblast Limited announced the completion of patient treatment in its pivotal Phase 3 MSB-DR004 trial for rexlemestrocel-L, a therapy targeting chronic low back pain associated with degenerative disc disease. The company randomized and treated 350 patients, increasing enrollment from an initial target of 300 due to strong investigator demand. The trial's primary endpoint assesses durable pain reduction at 12 months following a single intra-discal injection. Top-line results are expected in mid-2027 after the final patient completes follow-up. Rexlemestrocel-L holds Regenerative Medicine Advanced Therapy designation from the FDA, potentially allowing for priority review upon Biologics License Application filing. Mesoblast operates as a global leader in developing allogeneic cellular medicines for inflammatory diseases.

Mesoblast Limited reported Ryoncil net revenues of US$36 million for the quarter ended June 30, 2026, and US$115 million for its first full year post-FDA approval. The company held US$103 million in cash after drawing down an additional US$50 million from a five-year facility to extinguish all maturing debt obligations. Ryoncil registration trials for adults with steroid-refractory acute graft versus host disease have commenced, and the FDA granted Investigational New Drug clearance for a trial in children aged 5-9 years with Duchenne muscular dystrophy. Mesoblast also achieved its target of treating at least 300 patients in the pivotal Phase 3 trial for rexlemestrocel-L in chronic low back pain and received a BLA filing number for an indication related to heart failure. The company operates in the biotechnology industry, developing allogeneic cellular medicines for inflammatory diseases.