Mesoblast Limited MESO announced that it has completed patient treatment in a pivotal phase III MSB-DR004 study, evaluating its pipeline candidate, rexlemestrocel-L, for treating chronic low back pain (CLBP) caused by the inflammatory condition of degenerative disc disease.
Shares of Mesoblast were up 9.1% yesterday following the announcement of the news.
The late-stage study randomized 350 patients to receive either an intradiscal injection of rexlemestrocel-L or a sham injection. The number of patients enrolled increased from 300 to 350 following strong demand from study investigators to enroll additional patients.
Per management, completing treatment of 350 patients in the study marks a major milestone, as the study is now adequately powered to demonstrate a greater treatment benefit with rexlemestrocel-L versus the control group.
MESO Stock Performance
Year to date, shares of Mesoblast have lost 5.7% against the industry’s 5.1% rise.
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More on MESO’s Pivotal MSB-DR004 Study
The primary endpoint of the late-stage study is to check durable pain reduction after 12 months of treatment from a single intradiscal injection of rexlemestrocel-L. Key secondary endpoints include improvement in quality of life, function and reduced opioid usage.
Top-line data from the study is expected in mid-2027.
The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to rexlemestrocel-L for treating CLBP caused by degenerative disc disease. This designation could make the therapy eligible for priority review once the biologics license application (BLA) is filed.
Per the press release, CLBP caused by inflammation and degenerative disc disease is a serious condition affecting more than seven million people in the United States alone. The indication could be a major growth opportunity for Mesoblast, with potential peak annual revenues of more than $10 billion.
Mesoblast currently markets Ryoncil (remestemcel-L-rknd), which is the first FDA-approved mesenchymal stromal cell therapy for the treatment of steroid-refractory acute graft versus host disease in pediatric patients aged two months and older.
The successful development and potential approval of rexlemestrocel-L will further strengthen Mesoblast’s commercial portfolio and form another source of revenue generation.
MESO’s Zacks Rank & Stocks to Consider
Mesoblast currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Repligen RGEN and Anika Therapeutics ANIK, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN shares have gained 3.2% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time. ANIK shares have surged 123.5% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.
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