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FDA Signals Support for Mesoblast’s Rexlemestrocel-L in Chronic Back Pain and Opioid Reduction

10:32am on Monday 19th of January, 2026 AEDT Healthcare
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FDA Signals Support for Mesoblast’s Rexlemestrocel-L in Chronic Back Pain and Opioid Reduction

10:32am on Monday 19th of January, 2026 AEDT
Key Points
  • FDA acknowledges clinically meaningful 12-month pain reduction with rexlemestrocel-L
  • Potential opioid reduction benefits may be included in product labelling
  • Second Phase 3 trial (MSB-DR004) over 50% enrolled, targeting 300 patients
  • Rexlemestrocel-L holds Regenerative Medicine Advanced Therapy (RMAT) designation
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