04:50 AM EST, 11/05/2025 (MT Newswires) -- Mesoblast (MESO) said Tuesday the US Food and Drug Administration will meet next month to review data on opioid reduction and stopping use from its first phase 3 study of rexlemestrocel L in chronic low back pain.

In that randomized study of 404 patients, including 168 on opioids at the start, more than three times as many on rexlemestrocel L plus hyaluronic acid stopped all opioids by 36 months versus saline, the company said.

Chronic low back pain is a major driver of long-term prescription opioid use, and Rexlemestrocel L has Regenerative Medicine Advanced Therapy designation for this condition, Mesoblast said.

Mesoblast is seeking approval based on pain reduction through 12 months and is running a 300-patient confirmatory phase 3 at about 40 US sites, with enrollment expected to finish in Q4, the company added.