Back to top

Image: Bigstock

TGTX Stock Up on Positive Phase I Data for Subcutaneous Briumvi

Read MoreHide Full Article

Key Takeaways

  • TGTX rose 9.5% after positive phase I data for the subcutaneous formulation of Briumvi.
  • Briumvi's high-concentration SC version showed more than 60% bioavailability versus the IV formulation.
  • TG Therapeutics said latest data support quarterly SC dosing in the ongoing phase III study.

Shares of TG Therapeutics (TGTX - Free Report) were up 9.5% yesterday after the company announced positive data from a phase I study evaluating the subcutaneous (“SC”) formulation of its sole marketed drug, Briumvi (ublituximab-xiiy).

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.

The phase I study evaluated the bioavailability, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of a high-concentration (400 mg/2 mL) SC formulation of Briumvi versus the IV formulation.

Data from the study showed that treatment with the SC formulation of Briumvi led to a mean bioavailability of more than 60% compared to the current IV version. Bioavailability refers to how much of a drug actually reaches the bloodstream and becomes available to work in the body.

Notably, the high-concentration SC version of Briumvi appeared to work as expected and was generally well tolerated, with no new safety concerns being reported.

Management noted that the latest data support the quarterly SC dosing regimen for Briumvi, which is currently being evaluated in the ongoing phase III study, in achieving its primary endpoint. Top-line data from this phase III study is expected to be announced by the end of 2026 or early 2027.

TGTX’s Price Performance

Year to date, shares of TG Therapeutics have risen 34.6% against the industry’s 4.1% decline.

Zacks Investment Research
Image Source: Zacks Investment Research

TGTX Rides on Strong Briumvi Sales Performance

TG Therapeutics’ top line primarily comprises product sales from Briumvi. The drug 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, surging 63% year over year. Sales of the drug came in ahead of management’s guided range of $185-$190 million.

Reflecting the strong sales performance of Briumvi, TG Therapeutics raised its total revenue guidance.

The company now expects worldwide total revenues of around $925 million in 2026, up from the previous range of $875 million to $900 million.

Net product revenues from Briumvi sales in the United States are now expected to be in the range of $885-$900 million in 2026, up from the previous expectation of $825-$850 million.

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 and further boost sales in future quarters.

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 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share (EPS) have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen from $3.66 to $4.27. INDV shares have fallen 1.3% 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 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 61.5% 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 17.5% 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%.

Zacks' 7 Best Strong Buy Stocks (New Research Report)

Valued at $99, click below to receive our just-released report predicting the 7 stocks that will soar highest in the coming month.

Click Here, It's Really Free

Published in