TG Therapeutics TGTX announced that it has initiated a phase II study evaluating Briumvi (ublituximab-xiiy) for the treatment of adult patients with treatment-resistant schizophrenia.
Shares of the company were up 4.1% yesterday following the announcement of the news.
The open-label phase II study is designed to evaluate the safety and efficacy of Briumvi in around 60 adult patients with schizophrenia who continue to experience significant symptoms despite receiving standard-of-care antipsychotic treatment.
The primary endpoint of the study is to check the proportion of patients achieving at least a 20% reduction from baseline in PANSS total score at week 12 following treatment with Briumvi, while secondary endpoints include additional standard efficacy assessments as well as safety and tolerability.
Per management, the study is expected to help determine whether B-cell depletion with Briumvi can improve symptoms in adult patients with treatment-resistant schizophrenia.
TG Therapeutics’ sole marketed drug, Briumvi, which is an anti-CD20 monoclonal antibody, is currently approved for the treatment of adult patients with relapsing forms of multiple sclerosis (“RMS”) as an intravenous (IV) formulation.
TGTX Price Performance
Year to date, shares of TG Therapeutics have rallied 86.1% compared with the industry’s increase of 7.8%.
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TGTX’s Other Development Activities With Briumvi
Several label expansion studies evaluating Briumvi in other autoimmune diseases are currently underway.
TG Therapeutics is developing a self-administered subcutaneous formulation of Briumvi for treating RMS in a pivotal phase III study. Top-line data from this study are expected to be announced by the end of 2026 or early 2027.
If successfully developed, the Briumvi SC formulation may eventually be available as a quick injection rather than a lengthy IV infusion, which could make treatment more convenient for patients.
The company recently initiated a phase II study to evaluate the efficacy and safety of Briumvi in maintaining clinical response in patients with myasthenia gravis (MG) who initially respond to treatment with the FcRn inhibitor, Vyvgart (efgartigimod).
Briumvi, which remains a key contributor to the company’s revenues, has been witnessing strong demand in recent quarters. It generated sales of $201.3 million in the first quarter of 2026, reflecting a 68.2% year-over-year increase.
Importantly, Briumvi's net product sales in the United States were $194.8 million in the first quarter, increasing 63% year over year. Sales of the drug came in ahead of management’s guided range of $185-$190 million.
The successful development of Briumvi across additional indications could help the drug reach a broader patient population and further drive sales.
TGTX's Zacks Rank & Stocks to Consider
TG Therapeutics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Amarin AMRN, Immunocore IMCR and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Amarin’s 2026 loss per share have narrowed from $15.20 to 65 cents. Over the same period, loss per share estimates for 2027 have narrowed from $13.00 to 51 cents. AMRN shares have risen 12.7% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 50.02%.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same time, estimates for 2027 earnings per share have increased from 24 cents to 87 cents. IMCR stock has lost 7.9% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $3.02, while estimates for 2027 have increased from $2.91 to $4.92 during the same time. LQDA shares have surged 129.7% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.
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This article originally published on Zacks Investment Research (zacks.com).