A key clinical milestone has put ASX biotech stock Mesoblast Ltd (ASX: MSB) back on the radar on Wednesday.
The biotech announced a key milestone before the market opened, though investors are not getting carried away.
During midday trade, the share price is up 4% to $2.24.
Overall, it has been a rough year for Mesoblast, with the stock still down around 18% in 2026.
Here's what came through.
Image source: Getty Images
Phase 3 trial reaches key milestone
According to the release, Mesoblast has now fully enrolled patients in its Phase 3 trial for chronic low back pain.
The study is testing rexlemestrocel-L in patients with degenerative disc disease. It includes 300 participants and is designed to confirm results seen in an earlier Phase 3 study.
The earlier trial showed reductions in both pain and opioid use after a single injection.
With recruitment now complete, the study moves into the monitoring phase. Patients will be followed over 12 months, with the goal of showing a clear difference compared to a placebo.
Secondary endpoints include reduced opioid use, which has become a bigger focus in the US healthcare system.
What this actually changes
While the update does not bring revenue closer, it does remove another layer of uncertainty around the trial.
Large clinical studies can take time to recruit patients, so reaching full enrolment keeps the timeline on track and gives investors something more concrete to follow.
If the data lines up with earlier findings, Mesoblast expects it could support a regulatory filing in the United States in 2027.
The therapy has already received regenerative medicine advanced therapy designation from the US FDA, which can speed up the review process.
Looking further ahead
Chronic low back pain linked to degenerative disc disease is a large and growing market.
Mesoblast estimates more than 7 million people in the United States are affected.
The company believes even modest uptake could translate into significant revenue over time.
But there are still a few steps before that happens.
The trial needs to deliver positive results, and regulators will need to approve the therapy.
After that, it still needs to be rolled out and taken up by doctors.
Foolish takeaway
The ASX biotech has moved another step forward, but I am still taking a wait-and-see approach.
The milestone keeps things moving, but the outcome now comes down to the data. Until those results land, it is hard to get too confident about the potential upside.
I will be watching from the sidelines here.
