Mesoblast Limited reported H1 FY2026 financial results showing significant improvement with total revenue of US$51.3 million, primarily driven by successful U.S. commercial launch of Ryoncil®. The company generated US$48.7 million in product revenue with gross profit of US$44.2 million. Net loss improved to US$40.2 million from US$47.9 million year-over-year. Mesoblast has onboarded 49 transplant centers toward a target of 64, secured coverage for 280 million U.S. lives, and is advancing pipeline programs including Phase 3 trials for chronic low back pain and heart failure indications. Full-year FY2026 Ryoncil® revenue guidance is US$110-120 million.

Mesoblast reported that Ryoncil® (remestemcel-L-rknd), the first FDA-approved mesenchymal stromal cell therapy, achieved high survival outcomes in steroid-refractory acute graft-versus-host disease across children and adults in an EIND program. Data showed 15% mortality in third-line patients versus 2% in second-line Phase 3 trial patients, emphasizing the importance of earlier treatment initiation. The company plans to commence a pivotal Phase 3 trial in adults this quarter, potentially supporting label extension to a population three times larger than the pediatric market.

Mesoblast Limited reported a 60% quarter-over-quarter increase in Ryoncil gross sales to US$35 million for Q2 FY2026. Real-world data showed 84% survival rate in pediatric SR-aGvHD patients completing 28-day treatment. The company secured a new US$125 million non-dilutive credit facility at 8% interest and received positive FDA feedback on rexlemestrocel-L for chronic low back pain, with a Phase 3 confirmatory trial actively recruiting.

Mesoblast reported that 84% of the first 25 children treated with Ryoncil® (remestemcel-L-rknd) in real-world clinical settings completed the initial 28-day treatment regimen for steroid-refractory acute graft-versus-host disease. The company has onboarded 45 transplant centers with a target of 64, and has secured coverage extending to over 260 million U.S. lives. A pivotal trial in adults with severe SR-aGvHD is expected to commence enrollment this quarter.

The FDA provided positive feedback on Mesoblast's rexlemestrocel-L, an allogeneic cell therapy for chronic discogenic low back pain, acknowledging that pain reduction effects favor the active treatment over placebo at 12 months. The FDA confirmed this clinically meaningful reduction can support product efficacy and that opioid reduction results can be included in product labeling. A second Phase 3 trial (MSB-DR004) is over 50% enrolled with completion expected within three months.

Mesoblast Limited reported gross revenue of US$35.1 million for Ryoncil® in Q2 2025, representing a 60% increase from the prior quarter. The company secured a new US$125 million five-year facility with substantially lower costs, enabling repayment of prior senior debt and providing flexibility for strategic partnerships and label expansion efforts.

Mesoblast Limited announced board restructuring as it transitions to a revenue-generating commercial company. Jane Bell retired as Chair but remains as non-executive director, with Philip Facchina appointed as new non-executive Chair and Lyn Cobley as Audit and Risk Committee Chair. The company plans to strengthen U.S. commercial expertise over the next 12 months.

Mesoblast Limited announced it has repaid its senior secured loan from Oaktree Capital Management and partially repaid its subordinated royalty facility from NovaQuest Capital Management by drawing US$75 million from a new five-year facility provided by shareholder Dr Gregory George. The company has an option to draw an additional US$50 million by June 30, 2026. The new facility features a fixed 8.00% interest rate (lower than existing debt), no early prepayment fees, and does not encumber material assets or intellectual property.

An independent meta-analysis of 2,732 patients revealed that remestemcel-L showed superior clinical outcomes compared to ruxolitinib in treating steroid-refractory acute graft versus host disease (SR-aGvHD), with better complete and overall remission rates.

A comprehensive report reveals over 25 companies are actively developing new therapies for chronic heart failure, with promising pipeline drugs in various clinical trial stages targeting improved treatment options for an aging population.

Mesoblast reported a 37% increase in Ryoncil® gross revenue for Q4 2025, expecting over $30 million in sales, and continues developing cellular medicines for inflammatory conditions.

Mesoblast and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) will collaborate on a pivotal Phase 3 trial of Ryoncil® to treat severe acute graft versus host disease (aGvHD) in adults who are unresponsive to corticosteroids, aiming to improve survival rates.