Business UpdateApr 29, 2026, 08:57 PM
MESO Phase 3 CLBP Trial Hits Recruitment Target; Ryoncil Sales Near $100M
AI Summary
Mesoblast Limited announced significant achievements for the quarter ended March 31, 2026, including reaching the patient recruitment target in its pivotal Phase 3 trial for chronic low back pain. The company reported Ryoncil® gross sales of US$35.3 million for the quarter, with total revenues since launch approaching US$100 million. Net operating cash spend was substantially reduced to US$4.1 million, and the company held US$122 million in cash. Additionally, Mesoblast acquired an exclusive worldwide license to a CAR technology platform for precision-enhanced cell therapy products and received FDA clearances for new Ryoncil® trials.
Key Highlights
- Achieved patient recruitment target in pivotal Phase 3 trial for chronic low back pain (CLBP) with rexlemestrocel-L.
- Ryoncil® gross sales for the quarter ended March 31, 2026, were US$35.3 million.
- Ryoncil® net revenues for the quarter were US$30.3 million.
- Revenue generated since Ryoncil® launch approaches US$100 million.
- Net operating cash spend for the quarter was US$4.1 million.
- Mesoblast had US$122 million of cash at March 31, 2026.
- FDA cleared Ryoncil® label extension trial in adults with SR-aGvHD to begin.
- FDA granted IND clearance for Ryoncil® registrational trial in Duchenne’s muscular dystrophy (DMD).
- Acquired exclusive worldwide license to a patented CAR technology platform for precision-enhanced MSC products.