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TGTX Completes Enrollment in Phase III Study on Subcutaneous Briumvi
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Key Takeaways
TG Therapeutics finished enrollment in the phase III study of subcutaneous Briumvi for RMS patients.
TGTX's study compares two dosing regimens of subcutaneous Briumvi against the IV version.
TG Therapeutics expects top-line data by the end of 2026 or Q1 2027, with self-injection potential.
TG Therapeutics (TGTX - Free Report) announced that it has completed enrollment in the phase III study evaluating the subcutaneous formulation of its sole marketed drug, Briumvi (ublituximab-xiiy), for treating people with relapsing forms of multiple sclerosis (RMS).
The phase III study evaluated two subcutaneous dosing regimens of Briumvi, administered every two or three months, in the given patient population. The study is designed to assess the pharmacokinetics, pharmacodynamics, safety, and radiological and clinical outcomes of subcutaneous Briumvi versus the intravenous (IV) formulation in adults with RMS.
Top-line data from the same is expected to be announced by the end of 2026 or the first quarter of 2027.
The primary endpoint is to demonstrate non-inferior exposure of subcutaneous Briumvi compared with IV Briumvi, as measured by area under the curve at week 24.
A self-injectable version of Briumvi could allow patients to administer doses themselves at their convenience, lowering the need for visits to medical centers for intravenous infusion.
TGTX’s Price Performance
Year to date, shares of TG Therapeutics have rallied 16.1% compared with the industry’s rise of 3.1%.
Image Source: Zacks Investment Research
TGTX’s Top Line Driven by Robust Briumvi Sales
Briumvi, an anti-CD20 monoclonal antibody, is currently approved in several countries, including the United States and the European Union, for the treatment of adult patients with RMS. The drug is approved as a one-hour IV infusion administered twice a year, after the starting dose.
TG Therapeutics’ top line primarily comprises product sales from Briumvi, along with royalty and other revenues.
Briumvi generated sales of $606.9 million in 2025, up around 93.5% year over year. The drug has been witnessing strong adoption among patients in recent quarters, and this trend is likely to continue in 2026. The company expects net product sales of Briumvi to be in the range of $825-$850 million in the United States in 2026.
TG Therapeutics has completed patient enrollment in the phase III ENHANCE study, evaluating the potential to consolidate the day one and day 15 infusions of intravenous Briumvi into a single 600-mg infusion on day one. Top-line data from the study is expected in mid-2026.
Beyond MS, TG Therapeutics is also developing Briumvi for additional autoimmune indications, including a phase I study for treating patients with myasthenia gravis.
TGTX's Zacks Rank & Stocks to Consider
TG Therapeutics currently carries a Zacks Rank #3 (Hold).
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87, while the same for 2027 have increased from $2.85 to $3.25. CPRX shares have gained 10.8% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08, while the same for 2027 have increased from $3.22 to $3.41. INDV shares have lost 9.4% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
Over the past 60 days, estimates for Agenus’ 2026 earnings per share have risen from 54 cents to $1.30, while loss per share estimates for 2027 have narrowed from $1.91 to $1.52 during the same time. AGEN shares have soared 53.8% year to date.
Agenus’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 31.42%.
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TGTX Completes Enrollment in Phase III Study on Subcutaneous Briumvi
Key Takeaways
TG Therapeutics (TGTX - Free Report) announced that it has completed enrollment in the phase III study evaluating the subcutaneous formulation of its sole marketed drug, Briumvi (ublituximab-xiiy), for treating people with relapsing forms of multiple sclerosis (RMS).
The phase III study evaluated two subcutaneous dosing regimens of Briumvi, administered every two or three months, in the given patient population. The study is designed to assess the pharmacokinetics, pharmacodynamics, safety, and radiological and clinical outcomes of subcutaneous Briumvi versus the intravenous (IV) formulation in adults with RMS.
Top-line data from the same is expected to be announced by the end of 2026 or the first quarter of 2027.
The primary endpoint is to demonstrate non-inferior exposure of subcutaneous Briumvi compared with IV Briumvi, as measured by area under the curve at week 24.
A self-injectable version of Briumvi could allow patients to administer doses themselves at their convenience, lowering the need for visits to medical centers for intravenous infusion.
TGTX’s Price Performance
Year to date, shares of TG Therapeutics have rallied 16.1% compared with the industry’s rise of 3.1%.
Image Source: Zacks Investment Research
TGTX’s Top Line Driven by Robust Briumvi Sales
Briumvi, an anti-CD20 monoclonal antibody, is currently approved in several countries, including the United States and the European Union, for the treatment of adult patients with RMS. The drug is approved as a one-hour IV infusion administered twice a year, after the starting dose.
TG Therapeutics’ top line primarily comprises product sales from Briumvi, along with royalty and other revenues.
Briumvi generated sales of $606.9 million in 2025, up around 93.5% year over year. The drug has been witnessing strong adoption among patients in recent quarters, and this trend is likely to continue in 2026. The company expects net product sales of Briumvi to be in the range of $825-$850 million in the United States in 2026.
TG Therapeutics has completed patient enrollment in the phase III ENHANCE study, evaluating the potential to consolidate the day one and day 15 infusions of intravenous Briumvi into a single 600-mg infusion on day one. Top-line data from the study is expected in mid-2026.
Beyond MS, TG Therapeutics is also developing Briumvi for additional autoimmune indications, including a phase I study for treating patients with myasthenia gravis.
TGTX's Zacks Rank & Stocks to Consider
TG Therapeutics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the drug/biotech sector are Catalyst Pharmaceuticals (CPRX - Free Report) , Indivior Pharmaceuticals (INDV - Free Report) and Agenus (AGEN - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) presently. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87, while the same for 2027 have increased from $2.85 to $3.25. CPRX shares have gained 10.8% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08, while the same for 2027 have increased from $3.22 to $3.41. INDV shares have lost 9.4% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
Over the past 60 days, estimates for Agenus’ 2026 earnings per share have risen from 54 cents to $1.30, while loss per share estimates for 2027 have narrowed from $1.91 to $1.52 during the same time. AGEN shares have soared 53.8% year to date.
Agenus’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 31.42%.