U.S. FDA approves TG Therapeutics' multiple sclerosis drug; shares surge
Reuters
Published Dec 28, 2022 03:17PM ET
By Sriparna Roy and Khushi Mandowara
(Reuters) - TG Therapeutics (NASDAQ:TGTX) Inc said on Wednesday that the U.S. health regulator had approved its monoclonal antibody for treating patients with relapsing forms of multiple sclerosis, sending its shares up 47% in afternoon trade.
The approval by the U.S. Food and Drug Administration (FDA) widens the number of such drugs available for treating the disorder to three and may help soften the blow to the company's finances from the withdrawal of its lymphatic cancer drug earlier this year.
TG Therapeutics said it was expecting to launch the drug, branded as Briumvi, in the first quarter of 2023, but did not give details on its pricing.
Jefferies analyst Chris Howerton said ahead of the approval that he was expecting the drug to be priced in the range of $30,000 per patient per year. In comparison, Roche's Ocrevus has a current list price of about $68,000 annually.
Multiple sclerosis is a neurological disease in which the immune system attacks the brain cells causing motor disabilities. It affects about 400,000 people in the United States, according to the National Institutes of Health.
Unlike other MS drugs that target T cells, Briumvi belongs to a class of drugs that tackles B cells' role in driving the inflammation that is central to the neurological disease.
The approval, which comes with a warning of infusion reactions from the drug, was based on a late-stage study that showed the drug was effective in reducing the annualized relapse rates in patients.
Shares of the New York-based company were trading at a more than 10-month high of $11.48.
Get The News You Want
Written By: Reuters
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.