TG Therapeutics Announces Positive Results from Phase 1 Trial Evaluating Subcutaneous BRIUMVI® (ublituximab-xiiy)

About this update from Tg Therapeutics, Inc.

Pharmacokinetic and pharmacodynamic data support quarterly subcutaneous BRIUMVI dosing regimen currently under evaluation in fully enrolled Phase 3 trial; Top-line Phase 3 data expected year-end 2026 or early 2027  Novel Investigational high concentration subcutaneous formulation of BRIUMVI was well-tolerated with no new safety signals observed NEW YORK, June 03, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) (the “Company” or “TG Therapeutics”), today announced positive pharmacokinetic (PK), pharmacodynamic (PD), safety, and tolerability data from its Phase 1 clinical trial evaluating subcutaneous formulation of ublituximab (the active agent in BRIUMVI®) as compared to IV BRIUMVI. Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated, “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.” Mr. Weiss continued, “If approved, subcutaneous BRIUMVI would be the first and only self-administered, at-home, quarterly anti-CD20 therapy for people living with multiple sclerosis, significantly reducing the total number of injections per year as compared to currently available options. Strategically, given the distinct nature of the self-administered portion of the anti-CD20 market, a subcutaneous option could nearly double the addressable market opportunity for the BRIUMVI franchise. We look forward to reporting Phase 3 data later this year or early next year and, if successful, advancing toward a potential approval in 2028.”KEY FINDINGS FROM THE PHASE 1 SUBCUTANEOUS BRIUMVI TRIAL Design: The Phase 1 trial is evaluating the bioavailability, pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of a high-concentration (400 mg/2 mL) subcutaneous formulation of BRIUMVI compared to the currently approved intravenous (“IV”) formulation. To date, over 100 patients have been treated in the trial, including more than 80 patients who received subcutaneous BRIUMVI across multiple dose levels (50 mg – 400 mg) in single and multiple dose cohorts. More than 225 subcu...

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