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Mesoblast Ltd - MESO STOCK NEWS

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

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.

Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of Mesoblast's position in the market.

Rhea-AI Summary
Mesoblast receives positive feedback from the U.S. FDA on Phase 3 study for remestemcel-L in pediatric patients with SR-aGVHD, plans to resubmit BLA soon.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
78.64%
Tags
clinical trial
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Rhea-AI Summary
Mesoblast Limited raises A$97 million through entitlement offer and institutional placement, with Dr. Eric Rose subscribing for additional shares.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
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Rhea-AI Summary
Mesoblast Limited receives FDA support for an accelerated approval pathway for rexlemestrocel-L in patients with end-stage ischemic heart failure with reduced ejection fraction and a left ventricular assist device, based on positive results from a pivotal study.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
23.72%
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none
Rhea-AI Summary
Mesoblast Limited provided an operational update and financial results for the period ended December 31, 2023. The company reported positive engagement with the FDA across lead programs, strengthened its balance sheet, and reduced net cash usage. Mesoblast received Rare Pediatric Disease and Orphan Drug Designations for its cardiovascular product Revascor®. The company also discussed progress on Phase 3 trials for various conditions, including graft-versus-host disease and chronic low back pain.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-5.74%
Tags
earnings
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Rhea-AI Summary
Mesoblast Limited to host webcast discussing operational highlights and financial results for the six months ended December 31, 2023.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1.91%
Tags
earnings
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Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
6.22%
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none
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-3.83%
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none
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Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
11.63%
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none
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Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
3.01%
Tags
none
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
10.74%
Tags
partnership clinical trial
Mesoblast Ltd

Nasdaq:MESO

MESO Rankings

MESO Stock Data

508.41M
826.63M
0.73%
0.79%
Biological Product (except Diagnostic) Manufacturing
Manufacturing
Link
Australia
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