TG Therapeutics

In addition to a research pipeline including several investigational medicines, TG has completed a Phase III program for ublituximab, an investigational glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells, to treat patients with relapsing forms of multiple sclerosis.

Following a setback in June 2022, when the US regulator extended the Prescription Drug User Fee Act (PDUFA) goal date, the US FDA approved TG Therapeutics’ Briumvi (ublituximab-xiiy), for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Briumvi is the first and only anti-CD20 monoclonal antibody approved for patients with RMS that can be administered in a one-hour infusion following the starting dose, and the company says it expects to launch commercialization in the first quarter of 2023.

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