TG Therapeutics, Inc.

TG Therapeutics is a fully integrated, commercial-stage biotechnology company that acquires, develops, and sells new treatments for B-cell diseases. The company has a research pipeline and has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI (ublituximab-xiiy) to treat adult patients with relapsing forms of multiple sclerosis (RMS), which includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. BRIUMVI has also been approved by several regulatory agencies outside the U.S. for adult RMS patients with active disease, defined by clinical or imaging features. The company also assesses complementary products, technologies, and companies for in-licensing, partnerships, acquisitions, and investment. In December 2022, BRIUMVI received FDA approval based on data from the ULTIMATE I & II Phase 3 trials, which showed it was superior to teriflunomide in significantly reducing the annualized relapse rate (ARR), the number of T1 Gd-enhancing lesions, and the number of new or enlarging T2 lesions. These trial results were published in August 2022. TG Therapeutics commercially launched BRIUMVI in the U.S. in January 2023. In August 2023, the company entered into a commercialization agreement with Neuraxpharm Pharmaceuticals, S.L. BRIUMVI is an anti-CD20 monoclonal antibody administered to adults with RMS via a one-hour infusion every 24 weeks after the initial dose.