The Mesoblast Ltd (ASX: MSB) share price is catching the eye on Monday.
In morning trade, the biotech company's shares are up almost 7% to $2.36.
This compares favourably to a 0.25% decline by the S&P/ASX 200 index (ASX: XJO).
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Why is the Mesoblast share price jumping?
Investors have been fighting to get hold of the company's shares today following the release of a big update on a key trial.
According to the release, the allogeneic cellular medicines developer has completed patient treatment in the MSB-DR004 pivotal randomised controlled Phase 3 trial.
This is a trial of rexlemestrocel-L for chronic low back pain (CLBP) associated with the inflammatory condition of degenerative disc disease.
Mesoblast notes that the major milestone was achieved with 350 patients randomised and treated with either an intra-discal injection of rexlemestrocel-L or sham injection.
The total number of patients treated increased from 300 to 350 after strong demand from trial investigators to have their patients enrolled in the innovative program.
MSB-DR004
The company advised that the MSB-DR004 trial's primary endpoint aims to confirm the durable pain reduction at 12 months from a single intradiscal injection of rexlemestrocel-L seen in the earlier MSB-DR003 trial.
It believes that with 350 treated patients, the trial is well-powered for showing a greater treatment benefit in patients receiving rexlemestrocel-L compared with controls.
Secondary endpoints include improvements in function, quality of life, and cessation of pain medication, including opioids.
Large market opportunity
CLBP caused by inflammation and degenerative disc disease is a serious condition with a prevalence of over 7 million people in the U.S. alone.
Mesoblast estimates that the indication has potential peak year revenue of >US$10 billion, even with just single digit market penetration.
Rexlemestrocel-L has Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for treatment of CLBP due to degenerative disc disease.
This means it provides eligibility for priority review once the Biologics License Application (BLA) has been filed.
Top-line results are expected in mid-CY2027 after the last treated patient has completed 12 months follow-up.
Mesoblast's chief executive, Silviu Itescu, said:
Completing treatment of 350 patients in our pivotal low back pain trial is a momentous milestone for the company as we now count down to the 12-month read-out for what we hope will be the basis of our first blockbuster product.
The Mesoblast share price remains down almost 17% in 2026 despite today's positive move.
