Mesoblast Receives FDA Feedback on BLA Filing for rexlemestrocel-L in Chronic Low Back Pain
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
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Source: Globenewswire
- 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.
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 29.50 USD with a low forecast of 24.00 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.
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 17.730
Low
24.00
Averages
29.50
High
35.00
Current: 17.730
Low
24.00
Averages
29.50
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.
