TG Therapeutics Announces Positive Topline Phase 1 Data for Subcutaneous BRIUMVI in Patients with Myasthenia Gravis and Initiation of Potential Registration Directed Randomized Phase 2 Trial

About this update from Tg Therapeutics, Inc.

82% of subjects achieved an MCID in their MG-ADL with a mean >4 point improvement in MG-ADL observed in Phase 1 study of Subcutaneous BRIUMVI in patients with MG (n=11) Potential registration-directed Phase 2 trial utilizes novel sequential treatment approach designed to combine rapid symptom control of FcRn inhibition with sustained disease modification of B-cell depletion therapy NEW YORK, June 09, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) (the “Company” or “TG Therapeutics”), today announced positive topline Phase 1 data for BRIUMVI in patients with myasthenia gravis (MG) and the initiation of a Phase 2 clinical trial evaluating BRIUMVI as a maintenance therapy following induction with efgartigimod in adult patients with MG. Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated, “We are pleased to report positive data from 11 patients with myasthenia gravis treated with subcutaneous BRIUMVI in our Phase 1 study. These encouraging results support continued development of BRIUMVI in MG and also mark an important milestone in expanding the potential utility of BRIUMVI beyond Multiple Sclerosis.” Mr. Weiss continued, “We are also excited to initiate this potentially registration-directed Phase 2 study evaluating a novel sequential treatment approach in myasthenia gravis. By combining the rapid clinical benefit associated with FcRn inhibition with the durable disease control provided by B-cell depletion through BRIUMVI, we believe this strategy has the potential to establish a differentiated treatment paradigm in MG, while reducing the treatment burden associated with chronic FcRn therapy.” PHASE 1 RESULTS- MG COHORT Design: In an ongoing Phase 1 study evaluating subcutaneous BRIUMVI, 11 patients with AChR-antibody-positive MG (mean age 74, 73% male) received subcutaneous BRIUMVI across cohorts that demonstrated exposure at least equivalent to the approved IV BRIUMVI regimen. At baseline, patients had clinically meaningful disease burden, with mean baseline Myasthenia Gravis Activities of Daily Living (MG-ADL) of 8.24 (range 6 – 13) and mean baseline Quantitative Myasthenia Gravis (QMG) score of 12.0 (range 7 – 22). Key Data Highlights: Consistent reductions from baseline were observed across all myasthenia gravis outcome measures over time following treatment with subcutaneous BRIUMVIAt Week 24, 82% of patien...

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