Stock Markets June 3, 2026 10:57 AM

TG Therapeutics Shares Jump After Positive Phase 1 Data for Subcutaneous BRIUMVI

Early-stage results show a high-concentration, low-volume subcutaneous formulation was well tolerated and produced sustained drug exposure

By Maya Rios TGTX

TG Therapeutics shares climbed more than 10% in morning trading after the company reported encouraging Phase 1 data for a subcutaneous formulation of BRIUMVI (ublituximab-xiiy). The single-dose study found the high-concentration, low-volume formulation was well tolerated with no new safety signals and achieved sustained drug exposure consistent with expectations for subcutaneous delivery. Management also discussed the data at the Jefferies Global Healthcare Conference. The Phase 3 study, which has completed enrollment, is evaluating a quarterly subcutaneous dosing regimen with topline results expected by late 2026 or early 2027.

TG Therapeutics Shares Jump After Positive Phase 1 Data for Subcutaneous BRIUMVI
TGTX

Key Points

  • Phase 1 results show the subcutaneous high-concentration, low-volume formulation of BRIUMVI was well tolerated, with no new safety signals and sustained drug exposure consistent with expectations.
  • The Phase 3 trial evaluating a quarterly subcutaneous dosing regimen has completed enrollment and is targeting topline results by late 2026 or early 2027; a successful outcome could enable at-home self-administration.
  • Strong commercial performance underpins the clinical news - BRIUMVI generated about $205 million in Q1 2026 and TG Therapeutics raised full-year 2026 revenue guidance to approximately $925 million.

TG Therapeutics shares surged in early trading today, rising more than 10.3% after the company disclosed positive Phase 1 results for a subcutaneous version of its lead multiple sclerosis therapy, BRIUMVI (ublituximab-xiiy). The Phase 1 readout showed that the investigational high-concentration, low-volume formulation was well tolerated, presented no new safety signals, and delivered sustained drug exposure in line with expectations for subcutaneous administration.

The company’s chief executive, Michael S. Weiss, characterized the results as highly meaningful for the program, saying: "We are very pleased to report these positive Phase 1 results demonstrating that our proprietary high-concentration, low-volume subcutaneous formulation of BRIUMVI was well tolerated and achieved sustained drug exposure. Importantly, these data strengthen our confidence that the quarterly subcutaneous dosing regimen, currently being evaluated in the ongoing Phase 3 study, can achieve its primary endpoint."

TG Therapeutics used its presence at the Jefferies Global Healthcare Conference to present the Phase 1 findings directly to institutional investors, amplifying the announcement. Management noted that the ongoing Phase 3 trial has completed enrollment and is targeting topline results by late 2026 or early 2027. If the Phase 3 outcome is successful, the company said the subcutaneous option could enable a self-administered, at-home treatment approach that may substantially broaden the addressable patient population for BRIUMVI.

The clinical update arrives against a backdrop of solid commercial performance for the marketed intravenous formulation. BRIUMVI generated about $205 million in global revenue in the first quarter of 2026, and TG Therapeutics raised its full-year 2026 revenue guidance to approximately $925 million, up from a prior range of $875 million to $900 million.

Market context highlights that the stock’s advance was company-driven rather than the result of a broader market rally. Major U.S. indexes were soft on the day - the S&P 500 was down about 0.4%, the Dow Jones fell roughly 0.8%, and the NASDAQ slid near 0.5% - underscoring that the move in TG Therapeutics shares reflected company-specific developments.

At the time of the report, shares were trading at $40.41, well above the prior close of $36.64 and moving toward the upper end of the intraday range and nearer to the 52-week high of $44.65. The combination of supportive Phase 1 data, exposure at a high-profile investor event, and a strong underlying commercial trajectory converged to push the stock higher in morning trading.


What the company reported

  • Phase 1 data for a subcutaneous formulation of BRIUMVI indicated the high-concentration, low-volume product was well tolerated with no new safety signals.
  • The formulation achieved sustained drug exposure consistent with expectations for subcutaneous delivery.
  • Management presented the data at the Jefferies Global Healthcare Conference and emphasized the potential for a quarterly, at-home dosing regimen under evaluation in Phase 3.

Clinical and commercial timeline

  • The Phase 3 study has completed enrollment and is seeking topline results by late 2026 or early 2027.
  • BRIUMVI produced about $205 million in global revenue during Q1 2026, and full-year 2026 revenue guidance was raised to approximately $925 million.

Risks

  • Phase 3 results are not yet available - the Phase 1 readout is encouraging but the primary endpoint of the ongoing Phase 3 study has not been reported; this affects expectations for a quarterly subcutaneous dosing approval and commercialization.
  • Market headwinds are present - broader U.S. equity indexes were trading lower on the day, indicating the stock’s gain was company-specific and could be sensitive to future macroeconomic shifts.
  • Safety and regulatory uncertainty remain - while Phase 1 reported no new safety signals, longer-term and larger-scale safety and efficacy data from Phase 3 will determine the viability of a self-administered subcutaneous option.

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