Mesoblast said it has finished treating all 350 randomized patients in its pivotal Phase 3 MSB-DR004 study of rexlemestrocel-L for chronic low back pain associated with degenerative disc disease, raising the treated total from 300 after investigators pushed to enroll more patients. The single intra-discal injection study is designed to confirm durable pain reduction at 12 months, building on the earlier MSB-DR003 trial, while also measuring function, quality of life and reduced pain-medication use, including opioids. The company expects top-line results in mid-CY2027 and said the therapy already holds Regenerative Medicine Advanced Therapy (RMAT, expedited FDA pathway for regenerative treatments) designation, which can support priority review after a Biologics License Application (BLA, formal request to market a biologic) is filed. Mesoblast said the indication affects more than 7 million people in the United States and could represent peak annual revenue of more than US$10 billion even with single-digit market penetration.