other material
confidence high
sentiment positive
materiality 0.90
TG Therapeutics announces positive Phase 3 ENHANCE trial results for BRIUMVI consolidated dosing
TG THERAPEUTICS, INC.
- Phase 3 ENHANCE trial met primary endpoint, demonstrating bioequivalent drug exposure between single 600 mg Day 1 infusion and approved 150 mg Day 1 + 450 mg Day 15 regimen.
- Safety and tolerability of consolidated first infusion were consistent with established BRIUMVI profile; no Grade 3 or higher infusion reactions occurred.
- Supplemental BLA submission targeted for second half of 2026 based on these results.
- If approved, BRIUMVI would be the first and only IV anti-CD20 therapy initiated with a single infusion.