Mesoblast Reports Over $100M in RYONCIL Revenue and Provides Phase 3 Pipeline Update

2026-06-10SEC Filing 6-K (0001345099-26-000058)

Mesoblast Limited (NASDAQ: MESO) provided a corporate update via an ASX CEO Connect presentation on June 1, 2026. The company reported that its first FDA-approved product, RYONCIL (remestemcel-L), has generated over US$100 million in net revenue since its launch the previous year, with Q3 FY26 net revenue reaching US$30.3 million. The product is currently profitable on a standalone basis, with gross profits of US$44.2 million for 1H FY26. The company is reinvesting these proceeds into its pipeline, which includes three major Phase 3 assets. Key clinical milestones include the completion of patient recruitment for a pivotal Phase 3 trial of rexlemestrocel-L for chronic low back pain (CLBP), with top-line results expected in mid-2027. Mesoblast also plans to file a Biologics License Application (BLA) for rexlemestrocel-L in end-stage heart failure patients and is advancing label extensions for RYONCIL in adult aGvHD and Duchenne Muscular Dystrophy. As of March 31, 2026, the company maintained a cash balance of US$122 million and recently secured a US$125 million term loan to refinance existing debt.

Ticker mentioned:MESO