Welcome to our dedicated page for Mesoblast news (Ticker: $MESO), a resource for investors and traders seeking the latest updates and insights on Mesoblast stock.
Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect Mesoblast's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.
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Rhea-AI Summary
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 The FDA's draft guidance supports the potential approval of Ryoncil based on positive results from a single-arm trial in a population with refractory aGVHD where there are no available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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End-of-Day
10.74%
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Rhea-AI Summary
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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End-of-Day
-1.61%
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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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0.82%
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Mesoblast provides update on approval path for remestemcel-L in the treatment of SR-aGVHD
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-3.82%
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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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End-of-Day
12.59%
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Mesoblast to host webcast discussing Q4 and full year 2023 results
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-3.27%
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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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Rhea-AI Sentiment
End-of-Day
-58.9%
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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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1.22%
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0.83%
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Mesoblast Limited
Nasdaq:MESO
MESO Rankings
MESO Stock Data
838.81M
796.57M
0.75%
2.31%
Biological Product (except Diagnostic) Manufacturing
Manufacturing
United States of America
Melbourne
About MESO
mesoblast; (asx: msb; nasdaq:meso) is a world leader in innovative cell-based medicines. we have leveraged our proprietary technology platforms based on specialized cells known as mesenchymal lineage adult stem cells (mlcs) to establish what we believe is the most advanced cellular medicines portfolio in the industry. our ‘off-the-shelf’ products are allogeneic - meaning cells from one donor may be used in many different recipients without the need for matching. our licensee in japan has launched its mlc-based product for acute graft versus host disease in children and adults in japan. it is the first allogeneic cell-based product in japan to be fully approved in japan. we believe we are well positioned to have the first industrially manufactured allogeneic cell-based product approved in the united states. our lead product candidates under investigation are: • mpc-150-im for chronic heart failure • mpc-06-id for chronic low back pain due to disc degeneration • msc-100-iv for acute graf