Mesoblast reaches 300-patient Phase 3 treatment target

• Mesoblast enrolled 300 patients in a Phase 3 trial for its investigational chronic low back pain therapy.
• The company forecasts the treatment could generate over $10 billion in peak year revenue.
• Management expects to release top-line trial results for the clinical evaluation in mid-2027.

Mesoblast (NASDAQ:MESO) treated at least 300 patients in MSB-DR004, reaching the pivotal Phase 3 treatment target for rexlemestrocel-L in chronic low back pain.

The randomized, placebo-controlled trial compares one intra-discal rexlemestrocel-L injection with sham control over 12 months, seeking to confirm durable pain reduction reported in MSB-DR003.

The primary endpoint measures pain reduction at 12 months, while secondary measures cover function, quality of life and stopping pain medicines, including opioids, and Mesoblast said commercial manufacturing is progressing in parallel.

Mesoblast expects top-line results in mid-CY2027 and said RMAT designation makes a future BLA eligible for priority review.

Earlier MSB-DR003 results showed pain and opioid reductions for up to three years, while Mesoblast’s Ryoncil business reported preliminary net revenue of US$36 million for 4Q26 and US$115 million for FY2026.

Mesoblast also received a BLA filing number for rexlemestrocel-L in end-stage heart failure and said the back-pain indication could exceed US$10 billion in peak annual revenue at single-digit market penetration.