TG Therapeutics Inc - Company Profile
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Business Description
TG Therapeutics Inc (TG Therapeutics) is a biopharmaceutical company focused on the acquisition, development, and commercialization of novel treatments for B-cell diseases. The company operates in the biotechnology industry, with a particular emphasis on developing therapies for multiple sclerosis and other B-cell mediated diseases. TG Therapeutics has received FDA approval for BRIUMVI (ublituximab-xiiy) for treating relapsing forms of multiple sclerosis and has also secured approvals from the European Commission and the Medicines and Healthcare Products Regulatory Agency for the same indication in Europe and the UK.
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R&D Overview
TG Therapeutics has a major focus on its research and development operations for the development of novel monoclonal antibodies to treat various B-cell proliferative disorders including leukemia, lymphoma, and auto-immune diseases. Its pipeline products are Ublituximab IV, Ublituximab Subcutaneous for the treatment of relapsing multiple sclerosis; and Azer-Cel, for the treatment of B-cell disorders. The company has undertaken several R&D initiatives, including the late-stage clinical development of ublituximab-xiiy through the ULTIMATE I & II Phase 3 trials for relapsing multiple sclerosis (RMS), the ENHANCE Phase 3b trial evaluating alternative dosing regimens for BRIUMVI, and the development of subcutaneous ublituximab with ongoing Phase 1 and Phase 3 trials. Additionally, the company is developing azercabtagene zapreleucel (azer-cel), an allogeneic CD19-directed CAR T cell therapy for autoimmune diseases, with a Phase 1 trial underway for progressive multiple sclerosis. In FY2025, the company spent US$160.2 million on its R&D activities, which as a percentage of revenue stood at 26%, and grew 69.9% YoY.
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