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Mesoblast Limited - MESO STOCK NEWS

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.

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.

Rhea-AI Summary

Mesoblast (Nasdaq: MESO) has resubmitted its Biologics License Application (BLA) to the FDA for Ryoncil® (remestemcel-L), targeting treatment for children with Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD).

This follows FDA guidance that recent Phase 3 clinical data supports the application. The BLA addresses Chemistry, Manufacturing, and Control (CMC) issues.

Ryoncil® has been granted Fast Track and Priority Review designations, indicating its potential to significantly improve outcomes for children with this serious condition. Approval is expected between two to six months from resubmission.

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Mesoblast (Nasdaq:MESO; ASX:MSB) announced that it will file a Biologics License Application (BLA) for its product, Ryoncil® (remestemcel-L), next week. The application seeks FDA approval to use Ryoncil® for treating children with steroid-refractory acute graft versus host disease (SR-aGVHD). If approved, this could position Mesoblast as a key player in treating pediatric inflammatory diseases, opening potential new revenue streams and solidifying its leadership in allogeneic cellular medicines.

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Mesoblast (Nasdaq:MESO; ASX:MSB) presented a corporate update at the Bell Potter Emerging Leaders Conference. CEO Silviu Itescu announced that the company plans to resubmit its Biologics License Application (BLA) for Ryoncil® (remestemcel-L) for treating steroid-refractory acute graft versus host disease to the FDA this quarter, with potential approval expected in the second half of 2024. The company is also advancing Phase 3 trials for heart failure and back pain treatments, with accelerated approval pathways from the FDA for the heart failure product Revascor® (rexlemestrocel). Mesoblast has a strong intellectual property position in the U.S., with patents covering mesenchymal stem cell compositions that could extend up to 2043, providing a significant commercial advantage.

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Mesoblast provided an activity report for the third quarter ended March 31, 2024, highlighting FDA clarity on licensure for remestemcel-L and rexlemestrocel-L. The FDA supports an accelerated approval pathway for rexlemestrocel-L in end-stage heart failure and remestemcel-L in pediatric graft versus host disease. Financially, Mesoblast strengthened its balance sheet, reduced debt, and implemented cost containment strategies.

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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.
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Mesoblast Limited raises A$97 million through entitlement offer and institutional placement, with Dr. Eric Rose subscribing for additional shares.
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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.
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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.
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Mesoblast Limited to host webcast discussing operational highlights and financial results for the six months ended December 31, 2023.
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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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FAQ

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

Nasdaq:MESO

MESO Rankings

MESO Stock Data

918.70M
1.14B
1.09%
0.41%
Biological Product (except Diagnostic) Manufacturing
Manufacturing
Link
United States of America
Melbourne