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 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: 16.080
Low
35.00
Averages
35.00
High
35.00
Current: 16.080
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 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
Mesoblast 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 its meeting, confirming that rexlemestrocel-L can significantly reduce pain intensity in chronic discogenic low back pain patients, supporting its Biologics License Application (BLA) and potentially opening new market opportunities for the company.
- Clinical Trial Progress: The second Phase 3 trial, MSB-DR004, is actively recruiting across 40 sites in the U.S., with over 50% enrollment completed, and is expected to reach its target of 300 patients in the next three months, which will further enhance the market competitiveness of rexlemestrocel-L if successful.
- Opioid Use Reduction: In the first Phase 3 trial, more than three times the number of patients treated with rexlemestrocel-L were able to cease opioid use by 36 months compared to controls, a result that not only helps address the opioid crisis in the U.S. but may also enhance Mesoblast's brand image.
- RMAT Certification Benefits: Rexlemestrocel-L has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation, providing advantages such as rolling review and priority review eligibility, which will expedite its market entry and boost investor confidence.
See More
Exelixis Reports Preliminary 2025 Revenue of $2.123 Billion, Shares Drop 4.6%
- Financial Performance Preview: Exelixis announced a preliminary US net product revenue of $2.123 billion for 2025, but the market reacted negatively, causing shares to drop 4.6% to $42.01 in pre-market trading, indicating investor caution regarding future performance.
- 2026 Outlook: The company projects net product revenue for 2026 to be between $2.325 billion and $2.425 billion, which, while optimistic, may not instill confidence in investors about achieving these targets, potentially impacting long-term growth expectations.
- Market Turbulence: Several stocks showed poor performance in pre-market trading, with Synchrony Financial down 9.5% to $78.61 and Stoke Therapeutics down 8.7% to $30.00, reflecting a generally bearish market sentiment possibly influenced by macroeconomic factors.
- Other Stock Movements: Capital One Financial and Bread Financial Holdings fell 8.4% and 8.3%, respectively, indicating that financial stocks are under pressure in the current market environment, prompting investors to closely monitor upcoming earnings reports for future trends.
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
Mesoblast 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 its meeting, confirming that rexlemestrocel-L can significantly reduce pain intensity in chronic discogenic low back pain patients, supporting its Biologics License Application (BLA) and potentially opening new market opportunities for the company.
- Clinical Trial Progress: The second Phase 3 trial, MSB-DR004, is actively recruiting across 40 sites in the U.S., with over 50% enrollment completed, and is expected to reach its target of 300 patients in the next three months, which will further enhance the market competitiveness of rexlemestrocel-L if successful.
- Opioid Use Reduction: In the first Phase 3 trial, more than three times the number of patients treated with rexlemestrocel-L were able to cease opioid use by 36 months compared to controls, a result that not only helps address the opioid crisis in the U.S. but may also enhance Mesoblast's brand image.
- RMAT Certification Benefits: Rexlemestrocel-L has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation, providing advantages such as rolling review and priority review eligibility, which will expedite its market entry and boost investor confidence.
See More
Exelixis Reports Preliminary 2025 Revenue of $2.123 Billion, Shares Drop 4.6%
- Financial Performance Preview: Exelixis announced a preliminary US net product revenue of $2.123 billion for 2025, but the market reacted negatively, causing shares to drop 4.6% to $42.01 in pre-market trading, indicating investor caution regarding future performance.
- 2026 Outlook: The company projects net product revenue for 2026 to be between $2.325 billion and $2.425 billion, which, while optimistic, may not instill confidence in investors about achieving these targets, potentially impacting long-term growth expectations.
- Market Turbulence: Several stocks showed poor performance in pre-market trading, with Synchrony Financial down 9.5% to $78.61 and Stoke Therapeutics down 8.7% to $30.00, reflecting a generally bearish market sentiment possibly influenced by macroeconomic factors.
- Other Stock Movements: Capital One Financial and Bread Financial Holdings fell 8.4% and 8.3%, respectively, indicating that financial stocks are under pressure in the current market environment, prompting investors to closely monitor upcoming earnings reports for future trends.
See More
