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Mesoblast Limited
MSB.AU
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James M. O’Brien Appointed Chief Financial Officer at Mesoblast | MESO Stock News

Mesoblast Limited has appointed James M. O’Brien as its US-based Chief Financial Officer. O’Brien brings extensive financial management experience from his roles at Actavis, Nycomed, Cognition Therapeutics, and Faron Pharmaceuticals. His appointment is part of Mesoblast's transition to a fully integrated commercial organization, focusing on commercializing Ryoncil® and expanding its label. Mesoblast is a leader in allogeneic cellular medicines for inflammatory diseases, with a strong global intellectual property portfolio and manufacturing capabilities.

StockTitan·
US
MESO
+2.17%
StockTitan·
US
MESO
+2.17%

FDA Review of Opioid-Reduction Data Could Be a Game Changer for Mesoblast (ASX:MSB)

Mesoblast Limited announced that the U.S. FDA will review Phase 3 data on its therapy rexlemestrocel-L for opioid reduction in chronic low back pain patients in December. This meeting could significantly impact Mesoblast's investment narrative, as the therapy's potential role in addressing the opioid crisis aligns with new guidance promoting non-opioid treatments. However, Mesoblast faces challenges, including a net loss of US$102.14 million and execution risks. The stock's fair value estimates vary widely, reflecting differing investor sentiments about its future potential.

Simplywall·
US
MESO
+2.17%
Simplywall·
US
MESO
+2.17%

Mesoblast to Meet With FDA Next Month to Discuss Rexlemestrocel-L and Opioid Cessation | MESO Stock News

Mesoblast Limited announced a meeting with the FDA in early December to discuss data on opioid reduction from its Phase 3 study of rexlemestrocel-L for chronic low back pain (CLBP). The study showed that patients treated with rexlemestrocel-L had over three times the rate of opioid cessation compared to controls. The FDA has emphasized the need for non-opioid treatments for chronic pain, and rexlemestrocel-L has received Regenerative Medicine Advanced Therapy designation. Mesoblast is actively recruiting for a confirmatory Phase 3 trial to further evaluate the treatment's efficacy.

StockTitan·
StockTitan·

Mesoblast Announces Director’s Share Acquisition and New Equity Issuance

Mesoblast Limited (MESO) announced on October 28, 2025, that director William Burns acquired 120,000 ordinary shares, enhancing his holdings. This move aims to strengthen the company's financial position and shareholder value. The latest analyst rating for MESO is a Hold with a $17.50 price target. Spark's AI Analyst rates MESO as Neutral, highlighting strong growth potential but significant financial challenges. Mesoblast focuses on developing cellular medicines for inflammatory diseases, cardiovascular conditions, and orthopedic disorders, with a current market cap of $2.16B.

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Mesoblast Reports Strong Revenue Growth with Ryoncil® Adoption

Mesoblast Limited reported a 69% increase in net sales for Ryoncil® in Q3 2025, following the assignment of a permanent J-Code by CMS. The company has onboarded 40 transplant centers and expanded coverage to over 260 million US lives. Mesoblast plans a pivotal trial for Ryoncil® in adults with severe SR-aGvHD. Despite strong revenue growth, the stock rating is a Hold with a $20.00 price target, reflecting financial performance challenges. Mesoblast focuses on allogeneic cellular medicines and has a market cap of $2.21B.

Tip Ranks·
US
MESO
+2.17%
Tip Ranks·
US
MESO
+2.17%