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Mesoblast Limited (ASX:MSB)

ALERT: Price-sensitive ASX Announcement for MSB
Current share price for MSB : $2.170 -0.03 (-1.36%)+
Announcement
Release
17 Aug 2026 10:00AM
Price at Release
$2.200
Full Release
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Summary
Mesoblast Limited has announced the completion of patient treatment in its pivotal Phase 3 trial for chronic low back pain (CLBP) associated with degenerative disc disease. The trial, known as MSB-DR004, involved 350 patients receiving either rexlemestrocel-L or a sham injection. The major milestone aimed to validate the durable pain reduction seen in a prior trial and considers various secondary endpoints such as quality of life improvement and opioid use reduction. Rexlemestrocel-L has been granted RMAT designation by the FDA, allowing for priority review upon filing for a Biologics License Application. Results are expected by mid-2027.
Key Points
  • Completion of treatment in pivotal Phase 3 trial for CLBP.
  • 350 patients treated with rexlemestrocel-L or sham injection.
  • Primary endpoint focuses on pain reduction over 12 months.
  • Secondary endpoints include quality of life improvement and opioid reduction.
  • Rexlemestrocel-L has RMAT designation for FDA priority review.
  • Expect results by mid-2027.
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.