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published in Blogs
Dec 30, 2022
TG Therapeutics (TGTX, $10.40) gets FDA nod on RMS-treating antibody

TG Therapeutics (TGTX, $10.40) gets FDA nod on RMS-treating antibody

The U.S. Food and Drug Administration (FDA) approved TG Therapeutics Inc's Briumvi – a monoclonal antibody for treating patients with relapsing forms of multiple sclerosis (RMS).  Briumvi is the first and only anti-CD20 monoclonal antibody approved for RMS that can be administered in a one-hour infusion following the first dose.

The approval by the FDA may help offset the headwind to the company's finances from the withdrawal of its lymphatic cancer drug earlier this year. The approval was based on a late-stage study that suggested that the drug was effective in mitigating the annualized relapse rates in patients. It, however, comes with a caution of infusion reactions from the drug.

TG expects to launch Briumvi commercially in the U.S. in the first quarter of 2023.

Related Tickers: TGTX