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Mesoblast Limited American Depositary Shares - MESO STOCK NEWS

Welcome to our dedicated page for Mesoblast American Depositary Shares news (Ticker: MESO), a resource for investors and traders seeking the latest updates and insights on Mesoblast American Depositary Shares stock.

Mesoblast Limited (ASX: MSB; NASDAQ: MESO) is a leading biotechnology company specializing in innovative cell-based medicines. Leveraging its proprietary mesenchymal lineage adult stem cells (MLCs) technology, Mesoblast has established a robust portfolio of advanced cellular medicines. These 'off-the-shelf' allogeneic products use cells from a single donor to treat multiple recipients, eliminating the need for cell matching.

In Japan, Mesoblast's licensee has launched an MLC-based product for acute graft versus host disease (aGVHD) in both children and adults. This marks the first fully approved allogeneic cell-based product in Japan. In the United States, Mesoblast is poised to have its first industrially manufactured allogeneic cell-based product approved.

Mesoblast's lead product candidates include MPC-150-IM for chronic heart failure, MPC-06-ID for chronic low back pain due to disc degeneration, and MSC-100-IV for acute graft versus host disease. The company's pipeline also features remestemcel-L for steroid-refractory aGVHD, moderate to severe acute respiratory distress syndrome (ARDS), and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for advanced chronic heart failure and chronic low back pain.

Mesoblast boasts a strong global intellectual property portfolio, ensuring protection until at least 2041 in major markets. The company's proprietary manufacturing processes produce industrial-scale, cryopreserved, off-the-shelf cellular medicines, intended to be readily available worldwide. Two of its products have already been commercialized in Japan and Europe by its licensees.

Headquartered in Australia, with locations in the United States and Singapore, Mesoblast is listed on the Australian Securities Exchange and NASDAQ. For more information, visit the official website at www.mesoblast.com.

News

United States Food & Drug Administration (FDA) Grants Mesoblast Orphan-Drug Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease

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Mesoblast Limited receives Orphan-Drug Designation from FDA for allogeneic cell therapy Revascor in treating children with hypoplastic left heart syndrome, showing positive results in a clinical trial.
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Appendix 4C Quarterly Activity Report for Quarter Ended December 31, 2023

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Mesoblast Limited provided an activity report for the second quarter ended December 31, 2023. The report highlighted substantial operational progress across their three lead Phase 3 assets. They raised additional capital to support these programs, and received Rare Pediatric Disease (RPD) Designation from FDA for their cardiovascular product. Mesoblast also provided an update on their Phase 3 programs for Graft versus Host Disease, Cardiovascular conditions, and Chronic Low Back Pain. The financial report indicated a strengthened balance sheet, with a cash balance of A$113.4 million and cost containment strategies resulting in a 25% reduction in net operating cash spend from the comparative quarter in FY2023.
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United States Food & Drug Administration (FDA) Grants Mesoblast Rare Pediatric Disease Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease

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Mesoblast Limited announced that the FDA granted its allogeneic cell therapy Revascor a Rare Pediatric Disease Designation for the treatment of hypoplastic left heart syndrome (HLHS) in children. Results from a trial showed significant increases in left ventricular volumes, indicating potential for successful surgical correction and improved outcomes. Mesoblast is considering seeking accelerated approval for Revascor based on these positive results.
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Mesoblast Files for Orphan Drug and Pediatric Rare Disease Designations for Rexlemestrocel-L as Treatment for Severe Congenital Heart Disease

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Mesoblast Limited (MESO; MSB) has filed for orphan drug designation and rare pediatric disease designation with the FDA for its allogeneic cell therapy Revascor in the treatment of hypoplastic left heart syndrome. The filings were based on a prospective trial of REVASCOR in children with HLHS, showing promising results for improving left ventricular function. This move could lead to significant incentives and market exclusivity for Mesoblast's treatment.
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Mesoblast Partners With Blood and Marrow Transplant Clinical Trials Network (BMT CTN) on Pivotal Trial in Adults With SR-aGVHD

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Mesoblast Limited (MESO) has announced a partnership with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) to develop a pivotal trial for its lead product candidate Ryoncil® (remestemcel-L) in the treatment of adults with steroid-refractory acute graft versus host disease (SR-aGvHD). The FDA's draft guidance supports the potential approval of Ryoncil based on positive results from a single-arm trial in a population with refractory aGVHD where there are no available therapies. Mesoblast also intends to provide FDA with additional potency assay data for Ryoncil product manufactured using the current FDA-inspected process, linking product used in the pediatric Phase 3 trial with product for the proposed registration Phase 3 trial in adults. Mesoblast Chief Executive Silviu Itescu expressed optimism for having a product available for adults suffering from aGVHD and who have no other approved therapies.
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Appendix 4C Quarterly Activity Report for Quarter Ended September 30, 2023

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Mesoblast Limited provided an activity report for the first quarter ended September 30, 2023. The company had a productive meeting with the FDA regarding potential approvals of Ryoncil® in steroid-refractory acute graft versus host disease (SR-aGVHD). Mesoblast presented clinical data indicating high survival rates in children with SR-aGVHD using the improved RYONCIL product version. They believe these studies will support approval for the pediatric indication. Mesoblast also plans to commence a Phase 3 trial of RYONCIL in adults and adolescents with refractory aGVHD. The company has implemented cost reduction strategies and payroll reductions to preserve cash and reduce spend by 23% year on year. Cash balance at the end of the quarter was $53.2 million, with net operating cash spend of $14.2 million. Revenue from royalties on sales in Japan grew by 24% compared to the previous year.
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Jane Bell AM Appointed Chair of Mesoblast Audit and Risk Committee

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Mesoblast Limited appoints Jane Bell AM as Chair of the Board Audit and Risk Committee. She will focus on cost containment and cash preservation initiatives, targeting a 23% reduction ($15 million) in annual net operating cash for FY2024 and a 40% reduction in payroll by February 2024. She will also work on strengthening the balance sheet through royalty monetization and strategic partnerships.
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Key Outcomes From FDA Type A Meeting and Mesoblast Next Steps to Achieve RYONCIL Approval

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Mesoblast provides update on approval path for remestemcel-L in the treatment of SR-aGVHD
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Mesoblast Reports Financial Results and Operational Update for Fiscal Year Ended June 30, 2023

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Mesoblast reports financial results and operational update for Q2 2023, outlines cost containment strategy and discusses progress on remestemcel-L and rexlemestrocel-L
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Mesoblast Financial Results and Corporate Update Webcast

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Mesoblast to host webcast discussing Q4 and full year 2023 results
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FAQ

What is the current stock price of Mesoblast American Depositary Shares (MESO)?

The current stock price of Mesoblast American Depositary Shares (MESO) is $17.02 as of December 24, 2024.

What is the market cap of Mesoblast American Depositary Shares (MESO)?

The market cap of Mesoblast American Depositary Shares (MESO) is approximately 2.0B.

What is Mesoblast Limited's core business?

Mesoblast Limited specializes in developing and commercializing innovative allogeneic cellular medicines to treat complex diseases.

What are the key product candidates of Mesoblast?

Key products include MPC-150-IM for chronic heart failure, MPC-06-ID for chronic low back pain, and MSC-100-IV for acute graft versus host disease.

What is unique about Mesoblast's products?

Mesoblast's products are 'off-the-shelf' allogeneic cell-based medicines, meaning cells from one donor can be used to treat multiple recipients without matching.

Has Mesoblast commercialized any products?

Yes, Mesoblast has commercialized products in Japan and Europe through its licensees.

What recent achievements has Mesoblast made?

Mesoblast's licensee in Japan launched an MLC-based product for acute graft versus host disease in children and adults, marking the first fully approved allogeneic cell-based product in Japan.

Where is Mesoblast Limited headquartered?

Mesoblast Limited is headquartered in Australia, with additional locations in the United States and Singapore.

How can I stay updated with Mesoblast's latest news?

You can stay updated by visiting the official website at www.mesoblast.com and following their LinkedIn and Twitter accounts.

What is the significance of Mesoblast's intellectual property portfolio?

Mesoblast's strong global intellectual property portfolio ensures protection of their technology until at least 2041 in major markets.

What are Mesoblast's main areas of research and development?

Mesoblast focuses on developing treatments for chronic heart failure, chronic low back pain, acute graft versus host disease, inflammatory bowel disease, and acute respiratory distress syndrome.

What makes Mesoblast’s manufacturing process unique?

Mesoblast's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf cellular medicines with defined pharmaceutical release criteria, making them readily available to patients globally.

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Mesoblast Limited American Depositary Shares

Nasdaq:MESO

MESO Rankings

#1987 Ranked by Market Cap
N/A Ranked by Dividends

MESO Stock Data

1.97B
114.04M
0.07%
1.43%
1.47%
Biotechnology
Healthcare
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United States of America
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