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TGTX's Single-Dose Briumvi Hits Bioequivalence Goal in MS Study
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Key Takeaways
TGTX's ENHANCE Study met its primary endpoint for a single 600 mg Briumvi infusion in relapsing MS patients.
Briumvi showed bioequivalent exposure over 16 weeks, with no new safety signals reported.
TGTX plans an FDA filing in H2 2026 to eliminate Briumvi's day 15 infusion dose.
TG Therapeutics (TGTX - Free Report) has announced positive top-line data from the late-stage ENHANCE study, which evaluated a consolidated single-infusion regimen of its sole marketed drug, Briumvi (ublituximab-xiiy), in adult patients with relapsing forms of multiple sclerosis (MS).
The study achieved its primary endpoint, demonstrating that a single 600 mg infusion of Briumvi on day 1 in patients with relapsing forms of MS achieved bioequivalent drug exposure over 16 weeks compared with the currently approved standard Briumvi initiation regimen that requires two initial doses two weeks apart. Secondary endpoints were consistent with previously conducted clinical studies on the drug, with no new safety signals observed.
We remind investors that the drug is already approved to treat adult patients with relapsing forms of MS, with an initial dosing regimen that requires the first infusion at a 150 mg dose on day one, followed by a second infusion of 450 mg on day 15. Thereafter, subsequent infusions of 450 mg are administered every 24 weeks.
Data from the ENHANCE study support the potential elimination of the day 15 dose. Based on the above study results, TGTX intends to file a supplemental biologics license application with the FDA in the second half of 2026. If approved, Briumvi would become the first intravenously (IV) administered anti-CD20 therapy initiated with a single infusion.
TGTX’s Share Price Performance
Year to date, shares of TG Therapeutics have risen 31.5% against the industry’s 0.5% fall.
Image Source: Zacks Investment Research
Briumvi — A Key Revenue Driver for TGTX
TG Therapeutics’ top line primarily comprises product sales from Briumvi. In the first quarter of 2026, the company recorded $201.3 million from Briumvi sales, up 68.2% year over year. Briumvi has been witnessing strong demand in recent quarters, and this trend is expected to continue as 2026 progresses.
Several additional studies on Briumvi targeting other autoimmune diseases are currently ongoing.
TG Therapeutics completed enrollment in the phase III study in April, evaluating the subcutaneous formulation of Briumvi for the treatment of relapsing forms of MS. Top-line data from the study are expected by the end of 2026 or the first quarter of 2027.
The company is also developing Briumvi for additional autoimmune indications, including a potentially registration-directed study evaluating Briumvi in patients with myasthenia gravis.
The successful development of Briumvi for additional indications will help TG Therapeutics address a broader patient population and diversify revenue growth.
TGTX's Zacks Rank & Stocks to Consider
TG Therapeutics currently carries a Zacks Rank #3 (Hold).
Over the past 30 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share (EPS) have increased from $3.00 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.33 from $3.69. INDV shares have risen 3.4% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 30 days, estimates for Liquidia’s 2026 EPS have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have surged 79.9% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 30 days, estimates for Immunocore’s 2026 loss per share have narrowed from 97 cents to 16 cents. Over the same period, estimates for 2027 have improved from a loss of 39 cents to earnings of 11 cents per share. IMCR shares have lost 17.8% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.
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TGTX's Single-Dose Briumvi Hits Bioequivalence Goal in MS Study
Key Takeaways
TG Therapeutics (TGTX - Free Report) has announced positive top-line data from the late-stage ENHANCE study, which evaluated a consolidated single-infusion regimen of its sole marketed drug, Briumvi (ublituximab-xiiy), in adult patients with relapsing forms of multiple sclerosis (MS).
The study achieved its primary endpoint, demonstrating that a single 600 mg infusion of Briumvi on day 1 in patients with relapsing forms of MS achieved bioequivalent drug exposure over 16 weeks compared with the currently approved standard Briumvi initiation regimen that requires two initial doses two weeks apart. Secondary endpoints were consistent with previously conducted clinical studies on the drug, with no new safety signals observed.
We remind investors that the drug is already approved to treat adult patients with relapsing forms of MS, with an initial dosing regimen that requires the first infusion at a 150 mg dose on day one, followed by a second infusion of 450 mg on day 15. Thereafter, subsequent infusions of 450 mg are administered every 24 weeks.
Data from the ENHANCE study support the potential elimination of the day 15 dose. Based on the above study results, TGTX intends to file a supplemental biologics license application with the FDA in the second half of 2026. If approved, Briumvi would become the first intravenously (IV) administered anti-CD20 therapy initiated with a single infusion.
TGTX’s Share Price Performance
Year to date, shares of TG Therapeutics have risen 31.5% against the industry’s 0.5% fall.
Image Source: Zacks Investment Research
Briumvi — A Key Revenue Driver for TGTX
TG Therapeutics’ top line primarily comprises product sales from Briumvi. In the first quarter of 2026, the company recorded $201.3 million from Briumvi sales, up 68.2% year over year. Briumvi has been witnessing strong demand in recent quarters, and this trend is expected to continue as 2026 progresses.
Several additional studies on Briumvi targeting other autoimmune diseases are currently ongoing.
TG Therapeutics completed enrollment in the phase III study in April, evaluating the subcutaneous formulation of Briumvi for the treatment of relapsing forms of MS. Top-line data from the study are expected by the end of 2026 or the first quarter of 2027.
The company is also developing Briumvi for additional autoimmune indications, including a potentially registration-directed study evaluating Briumvi in patients with myasthenia gravis.
The successful development of Briumvi for additional indications will help TG Therapeutics address a broader patient population and diversify revenue growth.
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 Indivior Pharmaceuticals (INDV - Free Report) , Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) , 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 30 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share (EPS) have increased from $3.00 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.33 from $3.69. INDV shares have risen 3.4% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 30 days, estimates for Liquidia’s 2026 EPS have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have surged 79.9% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 30 days, estimates for Immunocore’s 2026 loss per share have narrowed from 97 cents to 16 cents. Over the same period, estimates for 2027 have improved from a loss of 39 cents to earnings of 11 cents per share. IMCR shares have lost 17.8% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.