Mesoblast Limited

Mesoblast Limited Announces Remestemcel-L Superiority Over Ruxolitinib in Treating SR-aGvHD

Mesoblast's Chronic Lower Back Pain Phase III Study Data to be Discussed by FDA

Mesoblast Limited Reports Ryoncil® Sales Growth and Plans for Key Trials

Hester Recommends Mesoblast Limited Stock, Analysts Maintain Buy Rating

Shapiro Recommends Mesoblast Limited in Healthcare Sector

Mesoblast Limited Reports 66% Growth in Ryoncil® Sales to $21.9 Million

Mesoblast Product Designated as U.S. Origin, Tariff-Free

Mesoblast Limited's Ryoncil® Commercial Launch Achieves Success

Mesoblast Limited reports quarterly activities: Launch of Ryoncil® post FDA approval for treating acute GVHD

Mesoblast Limited Announces FDA Approval of Ryoncil Therapy Now Available for Purchase in the U.S.

Mesoblast Limited Announces Pricing Information of Ryoncil® Now Available in Major US Drug Pricing Databases

MESO

A study at the 67th ASH Annual Meeting found Remestemcel-L to be more effective than Ruxolitinib in treating steroid-refractory acute graft versus host disease (SR-aGvHD), showing superior remission rates. Mesoblast Limited, the company behind Remestemcel-L, is listed on Nasdaq as MESO and ASX as MSB.

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Mesoblast

Study at ASH Annual Meeting finds Remestemcel-L better than Ruxolitinib for SR-aGvHD treatment. Remestemcel-L showed superior outcomes in remission rates compared to Ruxolitinib.

An independent study presented at the ASH Annual Meeting concluded that Mesoblast's remestemcel-L is superior to ruxolitinib in treating steroid-refractory acute graft versus host disease (SR-aGvHD). The study involved 2,732 patients and showed better outcomes in complete and overall remission for remestemcel-L. Both treatments improved quality of life, but remestemcel-L had fewer adverse events. Mesoblast's Ryoncil® is the first FDA-approved mesenchymal stromal cell therapy for SR-aGvHD in children under 12.

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Independent Study Presented at American Society of Hematology (ASH) Annual Meeting Concludes Remestemcel-L Superior to Ruxolitinib in Clinical Outcomes as Treatment for SR-aGvHD | MESO Stock News

Mesoblast Limited announced its participation in the Piper Sandler 37th Annual Healthcare Conference in New York, where CEO Silviu Itescu will engage in a fireside chat. This highlights Mesoblast's strategic focus on expanding its innovative cellular therapies and maintaining industry positioning. The most recent analyst rating on Mesoblast stock is a Hold with a A$3.00 price target. Mesoblast is a leader in developing allogeneic cellular medicines for inflammatory diseases, with its flagship product Ryoncil approved for treating pediatric graft versus host disease.

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Mesoblast to Participate in Piper Sandler Healthcare Conference

Mesoblast Limited announced FDA approval for Ryoncil®, a therapy for steroid-refractory acute graft-versus-host disease in children, marking a major milestone. This approval transitions Mesoblast from development to commercialization, validating its scientific platform and strategy. The company plans to expand Ryoncil®'s use and seek further FDA approvals. Despite financial challenges, Mesoblast shows potential for future growth. The stock is rated Hold with a $14.50 target.

Mesoblast Achieves FDA Approval for Ryoncil®

Mesoblast Limited reported a strong financial performance at its AGM, with expected gross revenue of over $30 million from Ryoncil® sales for the quarter ending December 31, 2025, marking a 37% increase from the previous quarter. The company, a leader in allogeneic cellular medicines, continues to expand its product offerings and maintain a robust intellectual property portfolio. Forward-looking statements highlight potential risks and uncertainties in future financial performance and product development.

Mesoblast Trading Update at Annual General Meeting Highlights Continued Strong Growth in Ryoncil® Revenue | MESO Stock News

Mesoblast Limited and the NIH-funded Blood and Marrow Transplant Clinical Trials Network (BMT CTN) will start a pivotal Phase 3 trial of Ryoncil® for adults with severe acute graft versus host disease (aGvHD) refractory to steroids. This collaboration aims to extend the use of Ryoncil®, already FDA-approved for children, to adults. The trial will compare ruxolitinib alone versus combined with Ryoncil®, with enrollment starting in early 2026. This initiative addresses a significant unmet need and market opportunity larger than the pediatric market.

Mesoblast and BMT CTN to Initiate Pivotal Trial of Ryoncil® as Part of First-Line Regimen in Adults with Severe Acute GVHD Refractory to Steroids | 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.

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

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.

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

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.

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

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.