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Mesoblast Limited (ASX:MSB)

ALERT: Price-sensitive ASX Announcement for MSB
Current share price for MSB : $2.060 -0.09 (-4.19%)+
Announcement
Release
29 Apr 2026 9:50AM
Price at Release
$2.150
Full Release
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Summary
Mesoblast Limited announced the achievement of its patient recruitment target for the pivotal Phase 3 trial of rexlemestrocel-L, aimed at treating chronic low back pain (CLBP) associated with degenerative disc disease. The trial, which involves 300 randomized patients receiving a single intra-discal injection of rexlemestrocel-L or a sham control, aims to confirm previous results showing significant pain reduction and reduced opioid usage. The FDA has granted RMAT designation to rexlemestrocel-L, allowing for priority review upon filing a Biologics License Application. Top-line results are expected in mid-2027 to support a regulatory filing for FDA approval.
Key Points
  • Mesoblast achieved patient recruitment target in pivotal Phase 3 trial for CLBP.
  • The trial involves 300 patients randomized to receive rexlemestrocel-L or sham control.
  • Rexlemestrocel-L aims to treat chronic low back pain due to degenerative disc disease.
  • FDA has granted RMAT designation to rexlemestrocel-L.
  • Top-line results expected in mid-2027 to support FDA approval filing.
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.