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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.

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Mesoblast Limited announced that the FDA has provided a complete response to its Biologics License Application for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease. More data is required for marketing approval, and Mesoblast will conduct a targeted study in adults. The company remains committed to making remestemcel-L available to patients.
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Mesoblast Limited (Nasdaq:MESO; ASX:MSB) reported a cash balance of US$71.3 million at the end of the fourth quarter, with an additional US$40 million available. Revenue from royalties on sales of TEMCELL® HS Inj.1 in Japan was US$2.0 million. Net cash usage for operating activities was US$16.3 million, with US$7.2 million for manufacturing activities. The Biologics License Application (BLA) resubmission for remestemcel-L was accepted by the FDA with a goal date of August 2, 2023.
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Coya Therapeutics appoints Dr. Fred Grossman as President and Chief Medical Officer, succeeding Dr. Adrian Hepner. Dr. Grossman brings over 20 years of drug development expertise and will guide Coya's development programs, including COYA 302 for ALS treatment.
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Mesoblast Limited reported operational highlights and financial results for the period ended March 31, 2023. The FDA accepted the company's filing for the Biologics License Application (BLA) for remestemcel-L in the treatment of children with steroid-refractory graft versus host disease (SR-aGVHD) and set a goal date of August 2, 2023. The FDA also conducted a pre-license inspection of the manufacturing process for remestemcel-L. Mesoblast received Regenerative Medicine Advanced Therapy (RMAT) designation for rexlemestrocel-L in the treatment of chronic low back pain (CLBP) and expects enrollment for the pivotal trial to begin in Q3 2023. The DREAM-HF Phase 3 trial results for rexlemestrocel-L in patients with chronic heart failure were published in the Journal of the American College of Cardiology (JACC).
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Mesoblast Limited (NASDAQ:MESO; ASX:MSB) has successfully completed a global private placement, raising approximately US$40 million at A$0.85 per share, primarily from existing major shareholders in the US, UK, and Australia. The funds will support the commercialization of remestemcel-L for treating children with steroid-refractory acute graft versus host disease (SR-aGVHD), pending FDA approval, with a PDUFA goal date set for August 2, 2023. Additionally, proceeds will aid in the ongoing manufacturing of this product and the initiation of a Phase 3 clinical trial for rexlemestrocel-L aimed at chronic low back pain. CEO Dr. Silviu Itescu emphasized the company's commitment to bringing innovative treatments to market and acknowledged the strong support from major shareholders.

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Mesoblast Limited (Nasdaq: MESO) announced the FDA's ongoing review of its Biologics License Application (BLA) resubmission for remestemcel-L, targeting pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD). The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 2, 2023, and scheduled a Pre-License Inspection of the company’s manufacturing facility in Singapore. If approved, remestemcel-L will be the first allogeneic, off-the-shelf therapy for children under 12 with SR-aGVHD, addressing a significant unmet need. The therapy has shown promising survival data in clinical trials.

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Mesoblast Limited (Nasdaq: MESO) announced the FDA has accepted their resubmission of the Biologics License Application for remestemcel-L, a therapy for children with steroid-refractory acute graft versus host disease (SR-aGVHD). The FDA set a PDUFA goal date of August 2, 2023. If approved, remestemcel-L will be the first allogeneic 'off-the-shelf' medicine in the US and the first therapy for children under 12 with SR-aGVHD. The resubmission includes new long-term survival data and manufacturing improvements. The FDA has granted fast track and priority review designations for the therapy, highlighting the urgent need for effective treatments for SR-aGVHD.

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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.

Mesoblast Limited American Depositary Shares

Nasdaq:MESO

MESO Rankings

MESO Stock Data

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