Mesoblast Limited

Activity Report for Quarter Ended September 30, 2026 (Appendix 4C)

Mesoblast reported preliminary fiscal Q1 results with RYONCIL net revenue of $28 million, up 44% year-over-year, and September marking the highest month of new patient starts. Operating cash spend fell 86% to $2.1 million from $14.9 million a year earlier, leaving the company with $99 million in cash at quarter end. On the pipeline, all 350 patients in the pivotal Phase 3 trial of rexlemestrocel-L for chronic low back pain have completed treatment, with the 12-month durable pain reduction primary endpoint reading out next year. The FDA also confirmed the BLA filing for rexlemestrocel-L may proceed for prevention of life-threatening GI bleeding in LVAD heart-failure patients, under RMAT and Orphan Drug designations.

•4d ago

Mesoblast Receives FDA Approval for New Potency Assay to Release Commercial Ryoncil Product

Mesoblast received FDA approval to implement a new potency assay, TIBA, for release and stability monitoring of all new commercial lots of its approved MSC therapy Ryoncil. The assay adds sensitivity to detect potency shifts during manufacturing changes and will be used alongside existing IL-2Rα inhibition and CAP assays under the product's Biologics License. The approval supports Mesoblast's ability to scale and modify Ryoncil manufacturing while maintaining quality control on its first and only FDA-approved MSC product.

•1mo ago

Mesoblast Reports Substantial Revenue Growth to US$120M

Mesoblast reported FY2026 revenue of US$120.3 million, a massive increase from US$17.2 million in the prior year, driven by the successful U.S. commercial launch of RYONCIL for pediatric SR-aGvHD. The company significantly narrowed its net loss by 44% to US$57.5 million and ended the period with US$103 million in cash, bolstered by a new US$125 million non-dilutive credit facility. Operationally, Mesoblast completed patient treatment in its pivotal Phase 3 trial of rexlemestrocel-L for chronic low back pain, treating 350 patients with top-line data expected in mid-CY2027.

•2mo ago

Mesoblast Achieves Major Milestone Completing Patient Treatment in Pivotal Phase 3 Trial for Chronic Low Back Pain

Mesoblast completed patient treatment in its pivotal Phase 3 trial of rexlemestrocel-L for chronic low back pain, randomizing 350 patients. The trial is designed to confirm durable pain reduction at 12 months, with top-line results expected in mid-2027 under the FDA's RMAT designation pathway. Management cited a potential peak revenue opportunity exceeding $10 billion in the U.S., given the high prevalence of degenerative disc disease.

•2mo ago

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

Mesoblast reported Ryoncil net revenue of US$115 million for its first full year post-FDA approval, with US$36 million generated in the fourth quarter. Operationally, the company achieved its target of enrolling 300 patients in the Phase 3 CLBP trial for rexlemestrocel-L and received FDA IND clearance for a DMD registrational trial. The firm ended the period with US$103 million in cash after using a facility drawdown to extinguish maturing debt and announced a license for CAR-MSC technology targeting autoimmune diseases.

•3mo ago

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

Mesoblast announced it has treated at least 300 patients in its pivotal Phase 3 trial of rexlemestrocel-L for chronic low back pain, hitting the target needed to ensure the study is powered for success. Commercial manufacturing is proceeding in parallel to support a potential Biologics License Application filing, with top-line results expected in mid-2027. The indication targets over 7 million people in the U.S., with the company estimating peak revenue potential exceeding $10 billion.

•3mo ago

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

Mesoblast reported Ryoncil net revenue of US$36 million for the fourth quarter and US$115 million for the full fiscal year ended June 30, 2026. CEO Dr. Silviu Itescu noted strong uptake since launch, with revenues already exceeding initial projections. Management anticipates continued revenue growth in the coming fiscal year, citing momentum across major U.S. pediatric centers and a strong capital position.

•3mo ago