TG Therapeutics completes enrollment in subcutaneous BRIUMVI trial

NEW YORK - TG Therapeutics, Inc. (NASDAQ:TGTX) announced Monday the completion of enrollment in a Phase 3 trial evaluating subcutaneous BRIUMVI (ublituximab-xiiy) for relapsing forms of multiple sclerosis (RMS), according to a press release statement. The $5.1 billion market cap company has been profitable over the last twelve months, with revenue reaching $616 million and an impressive gross profit margin of 84%.

The trial evaluates two subcutaneous dosing regimens administered every two months or every three months. BRIUMVI is currently approved in the United States and several territories as a one-hour intravenous infusion administered twice yearly in adults with RMS.

The Phase 3 study is designed as a non-inferiority, randomized, open-label, parallel-group, multicenter trial evaluating pharmacokinetics, pharmacodynamics, safety, radiological and clinical effects of subcutaneous BRIUMVI compared to intravenous BRIUMVI. Participants are randomized into three arms: an every eight-week subcutaneous regimen, an every 12-week subcutaneous regimen, or the currently approved intravenous dosing schedule.According to InvestingPro analysis, TGTX appears undervalued at current levels, with analysts predicting continued profitability this year. The company trades at a P/E ratio of 11.08 while delivering 87% revenue growth.

The primary endpoint is non-inferior exposure of subcutaneous BRIUMVI compared to intravenous BRIUMVI with respect to area under the curve at week 24.

The company expects topline data from the trial around year-end 2026 or early 2027.

BRIUMVI is a monoclonal antibody that targets CD20-expressing B-cells. The drug is indicated in the U.S. for treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Relapsing multiple sclerosis is a chronic demyelinating disease of the central nervous system. Approximately 1 million people are living with MS in the United States, with about 85% initially diagnosed with relapsing-remitting multiple sclerosis.

In other recent news, TG Therapeutics reported its financial results for the fourth quarter of 2025, revealing a significant miss on earnings per share (EPS). The company posted an EPS of $0.14, falling short of the anticipated $0.37, a surprise of -62.16%. However, TG Therapeutics exceeded revenue expectations, reporting $192.57 million against a forecast of $188.73 million, marking a surprise of 2.03%. In another development, TG Therapeutics secured a five-year, $750 million senior secured credit facility with Blue Owl Capital, which allows for an additional $250 million in capital, potentially increasing the facility to $1 billion. The proceeds will be used to repay the existing $250 million credit facility, resulting in a net raise of $500 million.

Moreover, TG Therapeutics announced the publication of data from a post hoc pooled analysis of Phase 3 studies evaluating BRIUMVI in patients with highly active relapsing forms of multiple sclerosis. The analysis, published in Neurology and Therapy, assessed efficacy outcomes in 168 participants from the ULTIMATE I and II trials. Additionally, TG Therapeutics will present data on BRIUMVI at the American Academy of Neurology annual meeting in April 2026, with two poster presentations scheduled. These developments highlight TG Therapeutics’ ongoing efforts in advancing its research and financial strategies.

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