Mesoblast posts US$115 million in first full year of Ryoncil revenue

Mesoblast said Ryoncil generated US$115 million in net revenue in its first full year after FDA approval, including US$36 million in the fourth quarter and US$66.5 million in the second half of the fiscal year ended June 30, 2026. The company reported net operating cash spend of US$43.8 million for the full year and US$13.4 million for the second half, and said it held US$103 million in cash at June 30 after drawing US$50 million from an existing five-year facility to extinguish all maturing debt obligations. Operationally, Mesoblast said it has started a registrational trial to extend the FDA-approved label for Ryoncil beyond pediatric steroid-refractory acute graft versus host disease, or SR-aGvHD, into adults, with up to 40 U.S. sites expected to be activated this year covering about 60% of the roughly 8,500 annual U.S. allogeneic adult bone marrow transplant population. The company also said it received FDA Investigational New Drug clearance to move directly into a registrational trial of Ryoncil in ambulatory children aged 5-9 years with Duchenne muscular dystrophy, which it said affects about 15,000 children in the U.S. For rexlemestrocel-L, Mesoblast said it reached its target of at least 300 treated patients in its pivotal Phase 3 trial in chronic low back pain associated with degenerative disc disease, with patients to be followed to the study’s 12-month primary endpoint, and said the FDA assigned a Biologics License Application filing number for use in preventing life-threatening gastrointestinal bleeding linked to right ventricular dysfunction in end-stage heart failure patients with a left ventricular assist device. Chief Executive Dr. Silviu Itescu said uptake of Ryoncil at major U.S. pediatric centers continued to build and positioned the treatment for use next in adults with the disease, while the company aimed to reach key inflexion points including potential FDA approvals.