👀 Ones to watch: Undervalued stocks to buy before they report Q3 earningsSee Undervalued Stocks

Mesoblast shares tank after US FDA rejects cell therapy for children

Published 08/03/2023, 10:25 PM
Updated 08/04/2023, 12:40 AM
© Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo/File Photo
MSB
-
MEOBF
-
MESO
-

(Reuters) -The U.S. health regulator rejected Mesoblast's cell therapy for children under 12 years of age for treating a type of complication that occurs after a stem cell or bone marrow transplant, sending its Australia-listed shares crashing about 58% on Friday.

The U.S. Food and Drug Administration (FDA) required more data to support marketing approval for the company's lead product remestemcel-L, Mesoblast (ASX:MSB) said in a statement on Thursday.

Mesoblast shares slumped as much as 58.3% when they opened in Sydney, before marginally paring some losses to trade down 54.8% at A$0.49 by 0416 GMT.

The rejection is a blow to Mesoblast's hopes for a potential launch of the therapy, especially after its fundraising efforts over the last two years.

© Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo/File Photo

The drug developer was seeking the FDA's approval for a cell therapy to treat children with a type of graft versus host disease (GvHD), whose symptoms did not respond to standard steroid therapy or developed recurrence while continuing treatment.

There are no approved therapies in children for the condition in which the donor's bone marrow or stem cells attack the recipient.

 

 

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.