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TGTX Rises on Positive Phase I Data for Subcutaneous Briumvi in MG
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Key Takeaways
TGTX's phase I data showed SC Briumvi produced comparable exposure to the approved IV version.
TGTX reported 82% of patients reached clinically meaningful MG-ADL improvement by week 24.
The company is studying Briumvi as a maintenance therapy following induction with Vyvgart.
Shares of TG Therapeutics (TGTX - Free Report) were up 5.9% yesterday after the company announced positive top-line data from a phase I study evaluating the subcutaneous (“SC”) formulation of its sole marketed drug, Briumvi (ublituximab-xiiy), in patients with myasthenia gravis (MG).
Simultaneously, the company also announced the initiation of a phase II study evaluating Briumvi as a maintenance therapy following induction with argenx’s (ARGX - Free Report) blockbuster drug, Vyvgart (efgartigimod), in adult patients with MG.
Briumvi, 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.
In the phase I study, 11 patients with AChR antibody-positive MG received SC Briumvi across multiple cohorts. The treatment achieved drug levels in the body similar to those observed with the approved IV formulation of Briumvi.
The study showed that 82% of patients achieved the minimal clinically important difference (MCID) in their myasthenia gravis activities of daily living (MG-ADL) with a mean 4-point improvement in MG-ADL after receiving subcutaneous Briumvi at week 24. These early results support the continued development of Briumvi in indications beyond multiple sclerosis.
Briumvi generated sales of $201.3 million in the first quarter of 2026, reflecting a 68.2% year-over-year increase. Successful development in additional indications could provide a meaningful boost to Briumvi sales over the long term.
TGTX Price Performance
Year to date, shares of TG Therapeutics have rallied 45.5% against the industry’s decline of 2.5%.
Image Source: Zacks Investment Research
TGTX’s Phase II Study on Briumvi in MG
The phase II study, which is expected to enroll around 120 patients, is evaluating the safety and efficacy of Briumvi in maintaining clinical response in patients with MG who initially respond to treatment with the FcRn inhibitor Vyvgart.
The study is designed to assess whether Briumvi can safely help maintain the treatment benefits achieved with Vyvgart in the given patient population.
The study will initially use the Briumvi IV dosing regimen, while the SC version of Briumvi will be introduced later, after the completion of ongoing pharmacokinetic bridging studies in multiple sclerosis.
The primary endpoint of the study is to check the time to clinical worsening, defined as either a 2-point or greater increase in the MG-ADL score from baseline or a myasthenic crisis that requires hospitalization.
ARGX’s Vyvgart is approved for treating all adult patients with generalized myasthenia gravis, regardless of antibody status. Argenx recorded $1.3 billion in global Vyvgart sales in the first quarter of 2026, up 63% year over year.
Over the past 60 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 85.6% 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 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 period, EPS estimates for 2027 have risen from 24 cents to 87 cents. 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 Rises on Positive Phase I Data for Subcutaneous Briumvi in MG
Key Takeaways
Shares of TG Therapeutics (TGTX - Free Report) were up 5.9% yesterday after the company announced positive top-line data from a phase I study evaluating the subcutaneous (“SC”) formulation of its sole marketed drug, Briumvi (ublituximab-xiiy), in patients with myasthenia gravis (MG).
Simultaneously, the company also announced the initiation of a phase II study evaluating Briumvi as a maintenance therapy following induction with argenx’s (ARGX - Free Report) blockbuster drug, Vyvgart (efgartigimod), in adult patients with MG.
Briumvi, 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.
In the phase I study, 11 patients with AChR antibody-positive MG received SC Briumvi across multiple cohorts. The treatment achieved drug levels in the body similar to those observed with the approved IV formulation of Briumvi.
The study showed that 82% of patients achieved the minimal clinically important difference (MCID) in their myasthenia gravis activities of daily living (MG-ADL) with a mean 4-point improvement in MG-ADL after receiving subcutaneous Briumvi at week 24. These early results support the continued development of Briumvi in indications beyond multiple sclerosis.
Briumvi generated sales of $201.3 million in the first quarter of 2026, reflecting a 68.2% year-over-year increase. Successful development in additional indications could provide a meaningful boost to Briumvi sales over the long term.
TGTX Price Performance
Year to date, shares of TG Therapeutics have rallied 45.5% against the industry’s decline of 2.5%.
Image Source: Zacks Investment Research
TGTX’s Phase II Study on Briumvi in MG
The phase II study, which is expected to enroll around 120 patients, is evaluating the safety and efficacy of Briumvi in maintaining clinical response in patients with MG who initially respond to treatment with the FcRn inhibitor Vyvgart.
The study is designed to assess whether Briumvi can safely help maintain the treatment benefits achieved with Vyvgart in the given patient population.
The study will initially use the Briumvi IV dosing regimen, while the SC version of Briumvi will be introduced later, after the completion of ongoing pharmacokinetic bridging studies in multiple sclerosis.
The primary endpoint of the study is to check the time to clinical worsening, defined as either a 2-point or greater increase in the MG-ADL score from baseline or a myasthenic crisis that requires hospitalization.
ARGX’s Vyvgart is approved for treating all adult patients with generalized myasthenia gravis, regardless of antibody status. Argenx recorded $1.3 billion in global Vyvgart sales in the first quarter of 2026, up 63% year over year.
TG Therapeutics, Inc. Price
TG Therapeutics, Inc. price | TG Therapeutics, Inc. Quote
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 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 60 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 85.6% 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 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 period, EPS estimates for 2027 have risen from 24 cents to 87 cents. 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%.