Mesoblast Presentation at Investor Conference - June 03, 2024

NEW YORK, June 02, 2024 -- At the recent Bell Potter Emerging Leaders Conference, Mesoblast Limited (Nasdaq: MESO; ASX: MSB) Chief Executive Silviu Itescu presented significant updates on the company's progress and forthcoming milestones.

Resubmission of Biologics License Application (BLA):

Silviu Itescu emphasized that Mesoblast is preparing to resubmit its Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for its leading product, Ryoncil® (remestemcel-L). This product is targeted for treating steroid-refractory acute graft versus host disease (GVHD). The potential approval is anticipated in the latter half of the calendar year 2024.

Advancements in Heart Failure and Back Pain Treatments:

Dr. Itescu also highlighted the advanced stages of Mesoblast's heart failure and back pain treatment programs, both currently in Phase 3 trials. Notably, the FDA has provided constructive feedback on a possible accelerated approval pathway for the heart failure treatment, Revascor® (rexlemestrocel-L).

Intellectual Property Strength:

The presentation underscored Mesoblast’s robust intellectual property (IP) portfolio in the United States. The company has secured patents through 2032 for its mesenchymal stem cell compositions and their broad applications, including for GVHD. These patents could potentially be extended up to 2037 upon Ryoncil’s approval, with further patent filings possibly extending market exclusivity until 2043.

About Mesoblast:

Mesoblast is a global leader in the development of allogeneic (off-the-shelf) cellular therapies aimed at treating severe and life-threatening inflammatory conditions. The company has capitalized on its mesenchymal lineage cell therapy platform to create a comprehensive suite of late-stage product candidates. These candidates address severe inflammation by releasing anti-inflammatory agents that modulate various immune system components, thereby significantly reducing harmful inflammation.

The company's proprietary manufacturing techniques facilitate the production of large-scale, cryopreserved, off-the-shelf cellular medicines. These therapies, with specified pharmaceutical release criteria, are designed to be readily accessible to patients worldwide.

Mesoblast’s product pipeline includes candidates based on remestemcel-L and rexlemestrocel-L technologies. Remestemcel-L is being developed for treating inflammatory diseases in both pediatric and adult patients, including steroid-refractory acute GVHD and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is focused on treating advanced chronic heart failure and chronic low back pain.

Commercialization and Global Presence:

Mesoblast has successfully commercialized two products in Japan and Europe through its licensees. Additionally, the company has established commercial partnerships in Europe and China for specific Phase 3 assets. The company operates from locations in Australia, the United States, and Singapore, and is publicly traded on both the Australian Securities Exchange (MSB) and the Nasdaq (MESO).

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!