Wednesday, December 28, 2022 2:46:53 PM
Dec 28 (Reuters) - TG Therapeutics 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 nearly 9% 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 Brumvi, 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, Brumvi belongs to a class of drugs that tackles B cells' role in driving the inflammation that is central to 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. (Reporting by Sriparna Roy, Khushi Mandowara and Raghav Mahobe in Bengaluru; Editing by Anil D'Silva and Shailesh Kuber)
Recent TGTX News
- Form 8-K - Current report • Edgar (US Regulatory) • 08/06/2024 11:08:39 AM
- TG Therapeutics Reports Second Quarter 2024 Financial Results and Raises BRIUMVI® (ublituximab-xiiy) Full Year Revenue Guidance • GlobeNewswire Inc. • 08/06/2024 11:00:00 AM
- TG Therapeutics to Host Conference Call on Second Quarter 2024 Financial Results and Business Update • GlobeNewswire Inc. • 08/05/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/17/2024 08:48:08 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/17/2024 07:08:53 PM
- Form PX14A6G - Notice of exempt solicitation submitted by non-management • Edgar (US Regulatory) • 06/10/2024 03:23:35 PM
- TG Therapeutics to Participate in the Goldman Sachs 45th Annual Global Healthcare Conference • GlobeNewswire Inc. • 06/07/2024 11:50:00 AM
- TG Therapeutics to Participate in the Jefferies Global Healthcare Conference • GlobeNewswire Inc. • 06/03/2024 11:30:00 AM
- TG Therapeutics Announces Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the 2024 Consortium of Multiple Sclerosis Centers Annual Meeting • GlobeNewswire Inc. • 05/31/2024 11:30:00 AM
- TG Therapeutics Announces Schedule of Upcoming Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the 2024 Consortium of Multiple Sclerosis Centers Annual Meeting • GlobeNewswire Inc. • 05/28/2024 11:30:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/06/2024 08:59:11 PM
- TG Therapeutics Provides Business Update and Reports First Quarter 2024 Financial Results • GlobeNewswire Inc. • 05/01/2024 11:00:00 AM
- TG Therapeutics to Host Conference Call on First Quarter 2024 Financial Results and Business Update • GlobeNewswire Inc. • 04/30/2024 08:55:29 PM
- TG Therapeutics Announces Additional Data Presentations for BRIUMVI® (ublituximab-xiiy) in Multiple Sclerosis at the American Academy of Neurology 2024 Annual Meeting • GlobeNewswire Inc. • 04/18/2024 11:30:00 AM
- TG Therapeutics Awarded National Contract by the Department of Veterans Affairs for BRIUMVI as the Preferred Anti-CD20 for Relapsing Forms of Multiple Sclerosis • GlobeNewswire Inc. • 04/18/2024 11:00:00 AM
- TG Therapeutics Announces Presentation of Data for BRIUMVI® (ublituximab-xiiy) in Multiple Sclerosis at the American Academy of Neurology 2024 Annual Meeting • GlobeNewswire Inc. • 04/15/2024 11:30:00 AM
- TG Therapeutics Announces Schedule of Data Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the American Academy of Neurology 2024 Annual Meeting • GlobeNewswire Inc. • 03/08/2024 12:30:00 PM
- TG Therapeutics Announces Presentation of Data for BRIUMVI® in Multiple Sclerosis at the Americas Committee for Treatment and Research in Multiple Sclerosis Annual Forum • GlobeNewswire Inc. • 03/01/2024 12:30:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/29/2024 10:23:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/28/2024 12:24:56 PM
- TG Therapeutics Provides Business Update and Reports Fourth Quarter and Year-End 2023 Financial Results • GlobeNewswire Inc. • 02/28/2024 12:00:00 PM
- TG Therapeutics Announces Issuance of Additional Patents for BRIUMVI® (ublituximab-xiiy) • GlobeNewswire Inc. • 02/27/2024 12:30:00 PM
- TG Therapeutics Announces European Launch of BRIUMVI® (ublituximab-xiiy) • GlobeNewswire Inc. • 02/26/2024 12:00:00 PM
- TG Therapeutics to Host Conference Call on Fourth Quarter and Year-End 2023 Financial Results and Business Update • GlobeNewswire Inc. • 02/23/2024 12:30:00 PM
- TG Therapeutics Announces Schedule of Data Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the Americas Committee for Treatment and Research in Multiple Sclerosis Annual Forum • GlobeNewswire Inc. • 02/20/2024 12:30:00 PM
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