MESOBLAST LTD (MESO) Form 6-K — Aug 17, 2026
Mesoblast has completed patient treatment in its pivotal Phase 3 trial (MSB-DR004) of rexlemestrocel-L for chronic low back pain associated with inflammatory degenerative disc disease, with 350 patients randomized and treated via intra-discal injection or sham control. Enrollment was expanded from 300 to 350 patients after strong demand from trial investigators. The primary endpoint is durable pain reduction at 12 months from a single injection, seeking to replicate the positive result seen in the earlier MSB-DR003 trial. Top-line results are expected in mid-CY2027 after the last treated patient completes 12 months of follow-up.
Key figures
- Us clbp prevalence
- over 7 million people
- Ip protection through
- at least 2044
- Topline results expected
- mid-CY2027
- Initial enrollment target
- 300
- Potential peak year revenue
- >US$10 billion
- Granted patents or applications
- over 1,000
- Patients randomized and treated
- 350
- Primary endpoint followup months
- 12
- Discogenic share of us opioid prescriptions
- approximately 50%
AI analysis
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