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Mesoblast Limited (ASX:MSB)

ALERT: Price-sensitive ASX Announcement for MSB
Current share price for MSB : $2.060 -0.26 (-11.21%)+
Announcement
Release
14 Jul 2026 10:00AM
Price at Release
$2.320
Full Release
download
Summary
Mesoblast Limited announced the completion of their target of treating 300 patients in the pivotal Phase 3 trial (MSB-DR004) for chronic low back pain (CLBP) associated with degenerative disc disease. This trial is designed to confirm the durable pain reduction effect of rexlemestrocel-L, previously observed in an earlier trial. The primary endpoint aims for significant pain reduction at 12 months, with secondary endpoints focusing on improvements in function, quality of life, and reduction in pain medication, including opioids. Rexlemestrocel-L has received RMAT designation from the FDA, facilitating priority review when filing for a Biologics License Application. Final trial results are anticipated by mid-2027. Mesoblast, a leader in cellular medicines for inflammatory diseases, continues to strengthen its position with ongoing trials and a robust intellectual property portfolio.
Key Points
  • Mesoblast has achieved its target of 300 patients treated in the MSB-DR004 pivotal Phase 3 trial for chronic low back pain (CLBP) associated with degenerative disc disease.
  • The trial aims to confirm durable pain reduction from a single intra-discal injection of rexlemestrocel-L, seen in the earlier MSB-DR003 trial.
  • The primary endpoint is to show significant pain reduction at 12 months between rexlemestrocel-L and sham controls.
  • Secondary endpoints include improvements in function, quality of life, and cessation of pain medication, including opioids.
  • Rexlemestrocel-L has received RMAT designation from the FDA for CLBP treatment, providing eligibility for priority review post-BLA filing.
  • Top-line results of the trial are expected in mid-2027.
  • The trial is actively enrolling patients across multiple sites in the U.S.
  • Mesoblast is a leader in developing cellular medicines for inflammatory diseases and has a strong intellectual property portfolio.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.