Mesoblast Receives FDA Feedback for BLA Filing of rexlemestrocel-L
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 19 2026
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Source: NASDAQ.COM
- FDA Feedback: Mesoblast has received feedback from the FDA regarding its allogeneic cell therapy product, rexlemestrocel-L, indicating plans to file a Biologics License Application (BLA), marking a significant advancement in chronic discogenic low back pain treatment.
- Clinical Trial Results: In the MSB-DR003 randomized controlled Phase 3 trial, the FDA acknowledged the efficacy of rexlemestrocel-L in reducing chronic low back pain, with significant pain intensity reduction observed at 12 months, potentially supporting product efficacy.
- Labeling Update: The FDA noted that robust results on opioid use reduction from at least one adequate and well-controlled trial could be included in the Clinical Studies section of the product labeling, enhancing market competitiveness.
- RMAT Designation: rexlemestrocel-L has been designated as a Regenerative Medicine Advanced Therapy (RMAT) by the FDA, providing all the benefits of Breakthrough and Fast Track programs, including rolling review and priority review eligibility, further accelerating the path to market.
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Analyst Views on MESO
Wall Street analysts forecast MESO stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for MESO is 35.00 USD with a low forecast of 35.00 USD and a high forecast of 35.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 17.960
Low
35.00
Averages
35.00
High
35.00
Current: 17.960
Low
35.00
Averages
35.00
High
35.00
About MESO
Mesoblast Limited is an Australia-based company. The Company is engaged in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The Company has developing a range of late-stage product candidates, derived from its first and second generation proprietary mesenchymal lineage cell therapy technology platforms therapies for distinct indications. The Company’s Ryoncil (remestemcel-L-rknd) is an allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy. Its other product candidate is Revascor (rexlemestrocel-L). Rexlemestrocel-L is second generation mesenchymal lineage precursor cell product platform and is in late-stage development for treatment of: chronic heart failure (chf) and chronic low back pain (clbp) due to degenerative disc disease. The two products have been commercialized in Japan and Europe by the Company's licensees.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Mesoblast Reports Strong Q2 Performance with Ryoncil Sales Surge
- Significant Sales Growth: Ryoncil® achieved gross sales of $35 million in Q2 2025, reflecting a 60% increase from Q1 2025, indicating strong market demand that is expected to further drive revenue growth for the company.
- Enhanced Financing Flexibility: Mesoblast secured a new $125 million non-dilutive credit line at an 8% annual interest rate, significantly reducing financing costs and enhancing the company's flexibility for strategic partnerships and product expansion.
- Positive Clinical Outcomes: Among the first 25 patients treated with Ryoncil®, 84% completed the 28-day regimen, demonstrating the therapy's effectiveness and likely facilitating the company's pivotal trial for label extension in adults with SR-aGvHD.
- Encouraging FDA Feedback: Mesoblast received positive feedback from the FDA regarding the potential filing of a Biologics License Application for rexlemestrocel-L in chronic low back pain patients, which is expected to further enhance the company's market share in pain management.
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Mesoblast Reports Strong Q2 Performance and Financing Update
- Significant Sales Growth: Ryoncil® achieved gross sales of $35 million for the quarter ending December 31, 2025, reflecting a 60% increase from the prior quarter, indicating sustained market demand and enhancing future revenue sustainability.
- Increased Financing Flexibility: Mesoblast secured a new $125 million non-dilutive credit line at an 8% annual interest rate, significantly reducing financing costs and expected to provide greater flexibility for strategic partnerships and product label expansion.
- Positive Clinical Outcomes: Among the 25 patients treated with Ryoncil®, 84% completed the initial 28-day treatment regimen, demonstrating the product's effectiveness in addressing severe SR-aGvHD, further solidifying its market position.
- Encouraging FDA Feedback: Mesoblast received positive feedback from the FDA regarding the potential filing of a Biologics License Application for rexlemestrocel-L in chronic low back pain patients, which is expected to drive the company's expansion into new markets and enhance product line diversity.
Continue Reading