Mesoblast completes 350-patient Phase 3 treatment
- Mesoblast completed treatment of 350 patients in its pivotal Phase 3 MSB-DR004 trial of rexlemestrocel-L for chronic low back pain.
- Mesoblast shares were down 5.4% at $15.60 in pre-market trading following the announcement.
- Mesoblast expects topline results in mid-CY2027 and estimates the indication could generate more than US$10 billion in peak-year revenue at single-digit market penetration.
Mesoblast (NASDAQ:MESO) completed treatment of 350 patients in its pivotal Phase 3 MSB-DR004 trial of rexlemestrocel-L for chronic low back pain caused by degenerative disc disease.
The study expanded from its original 300-patient target after Mesoblast reported strong investigator demand, with participants randomized to rexlemestrocel-L or a sham injection.
The trial measures 12-month pain reduction as its primary endpoint, while secondary measures include function, quality of life and reduced use of pain medicines, including opioids.
Mesoblast expects topline results in mid-CY2027 and said rexlemestrocel-L's FDA RMAT designation provides eligibility for priority review after a BLA filing.
Following the announcement, Mesoblast's share price was down 5.4% at $15.60 in pre-market trading.
Mesoblast reported preliminary Ryoncil net revenue of US$36 million for the June 2026 quarter and US$115 million for its first full year following product launch.
The company also received an FDA BLA filing number for rexlemestrocel-L in an end-stage heart failure program and drew US$50 million from a five-year financing facility during June.
