Mesoblast Submits FDA Feedback for rexlemestrocel-L Application
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 19 2026
0mins
Should l Buy MESO?
Mesoblast provided feedback received from the U.S. Food & Drug Administration, FDA, on potential filing of a Biologics License Application, BLA, for its allogeneic cell therapy product rexlemestrocel-L in patients with chronic discogenic low back pain, CLBP. This follows FDA's Type B meeting review of data from Mesoblast's first randomized controlled Phase 3 trial, MSB-DR003, on pain reduction and relationship to decreased use or elimination of opioids for up to three years following a single rexlemestrocel-L administration. Mesoblast is seeking FDA approval for rexlemestrocel-L based on reduction in CLBP through 12 months. Comparing outcomes between rexlemestrocel-L and placebo from MSB-DR003 trial, FDA acknowledged that the effects on pain intensity appear to favor the active arm. FDA also confirmed that a clinically meaningful reduction in pain intensity in the active arm versus placebo at 12 months can support product efficacy and stated that the robust results on opioid reduction from at least one adequate and well controlled trial could be included in the Clinical Studies section of product labeling.
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Analyst Views on MESO
Wall Street analysts forecast MESO stock price to rise
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 17.040
Low
35.00
Averages
35.00
High
35.00
Current: 17.040
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.
Ryoncil Demonstrates High Survival Rates in Acute GVHD Treatment
- Importance of Early Intervention: Ryoncil has demonstrated high survival rates in patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD), emphasizing the need for early use of Ryoncil after steroid resistance to complete the full treatment course and maximize survival chances.
- Clinical Trial Results: Among 53 patients receiving Ryoncil as ≥ third-line treatment for SR-aGvHD, 15% died before completing the full course, compared to only 2% in the Phase 3 trial as second-line treatment, highlighting the significant advantage of early intervention.
- First FDA-Approved MSC Product: Ryoncil is the first mesenchymal stromal cell product approved by the U.S. FDA for any indication and the only product approved for children under 12 with steroid-refractory acute graft-versus-host disease, marking a significant breakthrough in this field.
- Market Performance Analysis: Mesoblast shares are currently trading at $17.73, 1.8% above the 20-day simple moving average but 2.3% below the 50-day moving average, indicating short-term strength while facing medium-term resistance in the market.
See More
Mesoblast Reports Ryoncil® Treatment Data for SR-aGvHD
- Survival Rate Improvement: At the 2026 ASTCT meeting in Salt Lake City, Mesoblast presented data showing that Ryoncil® achieves high survival rates in steroid-refractory acute graft-versus-host disease (SR-aGvHD) patients, regardless of age, emphasizing the critical importance of early intervention to maximize survival chances.
- Treatment Outcome Comparison: Among 53 SR-aGvHD patients receiving Ryoncil® as ≥ third-line treatment, 15% died before completing the treatment course, compared to only 2% in the Phase 3 trial receiving it as second-line therapy, highlighting the significant advantages of early treatment.
- Adult Trial Plans: Mesoblast plans to initiate a pivotal trial for second-line treatment in adults with SR-aGvHD following IRB approval, with enrollment expected to begin this quarter, and if successful, it will support label extension for Ryoncil® in adults, a market approximately three times the size of the pediatric population.
- Platform Technology Advantage: Ryoncil® is the first FDA-approved mesenchymal stromal cell product for SR-aGvHD treatment, showcasing Mesoblast's leadership in cellular therapies and laying the groundwork for future treatments of other inflammatory diseases.
See More
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.
See More
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.
See More
Mesoblast Limited Receives FDA Feedback on BLA Filing for Rexlemestrocel-L in Chronic Low Back Pain
- Positive FDA Feedback: Mesoblast received encouraging feedback from the FDA during a meeting, confirming that rexlemestrocel-L shows clinically meaningful pain intensity reduction in chronic discogenic low back pain, potentially supporting the Biologics License Application (BLA).
- Clinical Trial Progress: The first randomized controlled Phase 3 trial (MSB-DR003) demonstrated that patients treated with rexlemestrocel-L were over three times more likely to cease opioid use within 36 months compared to the saline control group, highlighting its potential in pain management.
- Ongoing Trial Recruitment: The second randomized controlled Phase 3 trial (MSB-DR004) is over 50% enrolled and is expected to complete the 300-patient target in the next three months, further validating the efficacy of rexlemestrocel-L.
- Accelerated Approval Application: Mesoblast is also seeking accelerated FDA approval for rexlemestrocel-L for ischemic heart failure, indicating the company's strategic focus on multiple indications.
See More
Mesoblast Receives FDA Feedback for BLA Filing of rexlemestrocel-L
- 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.
See More
Ryoncil Demonstrates High Survival Rates in Acute GVHD Treatment
- Importance of Early Intervention: Ryoncil has demonstrated high survival rates in patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD), emphasizing the need for early use of Ryoncil after steroid resistance to complete the full treatment course and maximize survival chances.
- Clinical Trial Results: Among 53 patients receiving Ryoncil as ≥ third-line treatment for SR-aGvHD, 15% died before completing the full course, compared to only 2% in the Phase 3 trial as second-line treatment, highlighting the significant advantage of early intervention.
- First FDA-Approved MSC Product: Ryoncil is the first mesenchymal stromal cell product approved by the U.S. FDA for any indication and the only product approved for children under 12 with steroid-refractory acute graft-versus-host disease, marking a significant breakthrough in this field.
- Market Performance Analysis: Mesoblast shares are currently trading at $17.73, 1.8% above the 20-day simple moving average but 2.3% below the 50-day moving average, indicating short-term strength while facing medium-term resistance in the market.
See More
Mesoblast Reports Ryoncil® Treatment Data for SR-aGvHD
- Survival Rate Improvement: At the 2026 ASTCT meeting in Salt Lake City, Mesoblast presented data showing that Ryoncil® achieves high survival rates in steroid-refractory acute graft-versus-host disease (SR-aGvHD) patients, regardless of age, emphasizing the critical importance of early intervention to maximize survival chances.
- Treatment Outcome Comparison: Among 53 SR-aGvHD patients receiving Ryoncil® as ≥ third-line treatment, 15% died before completing the treatment course, compared to only 2% in the Phase 3 trial receiving it as second-line therapy, highlighting the significant advantages of early treatment.
- Adult Trial Plans: Mesoblast plans to initiate a pivotal trial for second-line treatment in adults with SR-aGvHD following IRB approval, with enrollment expected to begin this quarter, and if successful, it will support label extension for Ryoncil® in adults, a market approximately three times the size of the pediatric population.
- Platform Technology Advantage: Ryoncil® is the first FDA-approved mesenchymal stromal cell product for SR-aGvHD treatment, showcasing Mesoblast's leadership in cellular therapies and laying the groundwork for future treatments of other inflammatory diseases.
See More
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.
See More
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.
See More
Mesoblast Limited Receives FDA Feedback on BLA Filing for Rexlemestrocel-L in Chronic Low Back Pain
- Positive FDA Feedback: Mesoblast received encouraging feedback from the FDA during a meeting, confirming that rexlemestrocel-L shows clinically meaningful pain intensity reduction in chronic discogenic low back pain, potentially supporting the Biologics License Application (BLA).
- Clinical Trial Progress: The first randomized controlled Phase 3 trial (MSB-DR003) demonstrated that patients treated with rexlemestrocel-L were over three times more likely to cease opioid use within 36 months compared to the saline control group, highlighting its potential in pain management.
- Ongoing Trial Recruitment: The second randomized controlled Phase 3 trial (MSB-DR004) is over 50% enrolled and is expected to complete the 300-patient target in the next three months, further validating the efficacy of rexlemestrocel-L.
- Accelerated Approval Application: Mesoblast is also seeking accelerated FDA approval for rexlemestrocel-L for ischemic heart failure, indicating the company's strategic focus on multiple indications.
See More
Mesoblast Receives FDA Feedback for BLA Filing of rexlemestrocel-L
- 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.
See More
