Highlights:

• Mesoblast has received US FDA approval to use a new potency test, the T-cell Proliferation Inhibition BioAssay (TIBA), for releasing and monitoring all new commercial lots of Ryoncil.
• TIBA will work alongside the two existing potency assays to confirm that each batch is consistent, potent and clinically effective.
• MSB shares last traded at AU$2.240, up AU$0.060 (2.752%).

Regulatory Milestone for Ryoncil

Mesoblast Limited (ASX: MSB), a leading developer of allogeneic cellular medicines for inflammatory diseases, announced on 24 September 2026 (New York) and 23 September 2026 (Melbourne) that the US Food and Drug Administration (FDA) has approved a new potency assay for its flagship product, Ryoncil® (remestemcel-L-rknd). The new test, called the T-cell Proliferation Inhibition BioAssay (TIBA), will be used for both the release and the stability monitoring of every new commercial lot of Ryoncil. This gives the company an additional quality control tool for its approved mesenchymal stromal cell (MSC) therapy.

How the New Assay Works

According to Mesoblast, TIBA is sensitive enough to detect any changes in the potency of the commercial product. Such shifts could occur when manufacturing processes are updated or when production moves to new facilities. This makes the assay especially useful as the company works to scale up and expand its manufacturing.

TIBA will form part of a testing matrix used to release each commercial batch. It will operate together with the existing potency assays, which measure IL-2Rα inhibition and Cell Adhesion and Proliferation (CAP), in line with the product's Biologics License. Together, these tests are designed to confirm that each batch of Ryoncil meets the required standards for consistency and effectiveness.

A First-of-its-Kind Therapy

Ryoncil holds a unique position in the market. It is the first FDA-approved allogeneic MSC product produced on an industrial scale for any indication. It is also the only MSC product approved for patients aged two months and older with steroid-refractory acute graft versus host disease (SR-aGvHD), a serious and often life-threatening complication after stem cell transplants.

Mesoblast said it has worked closely with the FDA since Ryoncil received commercial approval. The aim of this collaboration has been to keep both parties aligned on ongoing improvements to manufacturing and on the tests used for quality control.

Pipeline and Growth Plans

Beyond its current approval, Mesoblast is developing Ryoncil for other inflammatory conditions, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Mesoblast’s second platform product, rexlemestrocel-L, is under development for potential applications in heart failure and chronic low back pain. The company also has a portfolio of more than 1,000 granted patents and patent applications, with intellectual property protection extending to at least 2044 across major markets. Mesoblast has also established commercial partnerships across Japan, Europe and China.

Market Reaction

Investors responded positively to the update. Mesoblast shares last traded at AU$2.240, up AU$0.060 or 2.752%. The approval strengthens the company's manufacturing and quality framework, which could support future production growth and broader commercial supply of Ryoncil.

Note- All data presented is based on information available at the time of writing.

Disclaimer for Kapitales Research

The materials provided by Kapitales Research, including articles, news, data, reports, opinions, images, charts, and videos ("Content"), are intended for personal, non-commercial use only. The primary goal of this Content is to educate and inform readers. This Content is not meant to offer financial advice, nor does it include any recommendation or opinion that should be relied upon for making financial decisions. Certain Content on this platform may be sponsored or unsponsored, but it does not serve as a solicitation or endorsement to buy, sell, or hold any securities, nor does it encourage any specific investment activities. Kapitales Research is not authorized to provide investment advice, and we strongly advise users to seek guidance from a qualified financial professional, such as a financial advisor or stockbroker, before making any investment choices. Kapitales Research disclaims all liability for any direct, indirect, incidental, or consequential damages arising from the use of the Content, which is provided without any warranties. The opinions expressed by contributors or guests are their own and do not necessarily reflect the views of Kapitales Research. Media such as images or music used on this platform are either owned by Kapitales Research, sourced through paid subscriptions, or believed to be in the public domain. We have made reasonable efforts to credit sources where appropriate. Kapitales Research does not claim ownership of any third-party media unless explicitly stated otherwise.

Customer Notice:

Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.Disclosure: The information mentioned above has been sourced from the company reports and a third-party database, i.e. Koyfin. Investors are advised to use strict stop-loss to protect their investments in case of any unfavorable/uncertain market events.

Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com.au