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Mesoblast Limited announced the completion of patient treatment in its pivotal Phase 3 MSB-DR004 trial for…
MESOMesoblast Ltd
Mesoblast Limited announced the completion of patient treatment in its pivotal Phase 3 MSB-DR004 trial for rexlemestrocel-L, a therapy targeting chronic low back pain associated with degenerative disc disease. The company randomized and treated 350 patients, increasing enrollment from an initial target of 300 due to strong investigator demand. The trial's primary endpoint assesses durable pain reduction at 12 months following a single intra-discal injection. Top-line results are expected in mid-2027 after the final patient completes follow-up. Rexlemestrocel-L holds Regenerative Medicine Advanced Therapy designation from the FDA, potentially allowing for priority review upon Biologics License Application filing. Mesoblast operates as a global leader in developing allogeneic cellular medicines for inflammatory diseases.