Mesoblast Hits Phase 3 Recruitment Milestone in Chronic Back Pain Push

The latest announcement is out from Mesoblast Limited ( (AU:MSB) ).

Mesoblast has reached its patient recruitment target for a pivotal Phase 3 trial of rexlemestrocel-L in chronic low back pain caused by degenerative disc disease, a key step toward potential commercialization of the non-opioid, disease-modifying therapy. The placebo-controlled study will follow at least 300 patients for 12 months to assess reductions in pain and opioid use, building on earlier Phase 3 data that showed durable pain relief and decreased opioid consumption.

Top-line results are expected in mid-2027 and, if positive, will underpin a planned U.S. regulatory filing later that year, supported by the therapy’s RMAT designation that allows for an expedited review pathway. With chronic low back pain affecting over 7 million people in the U.S. and accounting for around half of prescription opioid use, the indication represents a potential blockbuster market for Mesoblast, which estimates peak annual revenue above $10 billion at low single-digit market penetration.

The most recent analyst rating on (AU:MSB) stock is a Buy with a A$3.23 price target. To see the full list of analyst forecasts on Mesoblast Limited stock, see the AU:MSB Stock Forecast page.

More about Mesoblast Limited

Mesoblast Limited is a biotechnology company specializing in allogeneic, off-the-shelf cellular medicines targeting severe and life-threatening inflammatory conditions. Its proprietary mesenchymal lineage cell therapy platforms, including remestemcel-L and rexlemestrocel-L, are being advanced across indications such as graft-versus-host disease, chronic low back pain and heart failure, with commercial partnerships in Japan, Europe and China.

Average Trading Volume: 3,864,259

Technical Sentiment Signal: Hold

Current Market Cap: A$2.83B

For detailed information about MSB stock, go to TipRanks’ Stock Analysis page.