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Mesoblast Prepares FDA Talks on Rexlemestrocel-L’s Opioid Cessation Promise

10:21am on Wednesday 5th of November, 2025 AEDT Healthcare
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Mesoblast Prepares FDA Talks on Rexlemestrocel-L’s Opioid Cessation Promise

10:21am on Wednesday 5th of November, 2025 AEDT
Key Points
  • FDA meeting scheduled for early December 2025
  • Phase 3 trial shows over threefold increase in opioid cessation with rexlemestrocel-L
  • Confirmatory 300-patient Phase 3 trial underway in the US
  • Rexlemestrocel-L holds Regenerative Medicine Advanced Therapy (RMAT) designation
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