BRIUMVI (ublituximab-xiiy) 150 mg/6 mL Injection for IV

July 06, 2026: TG Therapeutics, Inc. (NASDAQ: TGTX) announced initiation of an open-label, single-arm, multicenter Phase 2 trial of BRIUMVI (ublituximab-xiiy) in adults with treatment-resistant schizophrenia. The study plans to enroll ~60 participants ages 18–60 who remain symptomatic despite standard-of-care antipsychotic therapy; participants will receive IV BRIUMVI while continuing background antipsychotics.

Primary endpoint: proportion of participants achieving ≥20% reduction from baseline in PANSS total score at Week 12. Secondary endpoints include additional efficacy assessments plus safety/tolerability. The company cited emerging evidence for immune dysfunction/neuroinflammation in a subset of schizophrenia patients and noted preliminary findings with rituximab in a small cohort as rationale for evaluating B-cell depletion.

No timeline for data readout was provided. The release also references broader 2026 pipeline milestones/risks, including completing a pivotal program for subcutaneous ublituximab and enrolling trials evaluating BRIUMVI in myasthenia gravis (MG) and schizophrenia, and enrolling a trial for azer-cel.