other material
confidence high
sentiment positive
materiality 0.75
TG Therapeutics reports positive Phase 1 data for subcutaneous BRIUMVI; bioavailability >60% vs IV
TG THERAPEUTICS, INC.
- Mean bioavailability >60% relative to IV; lower bound of 95% CI >55%.
- PK modeling predicts non-inferior total drug exposure for quarterly SC dosing (GMR 1.21, lower 90% CI 1.15).
- Subcutaneous BRIUMVI well tolerated; injection-site reactions <5%, no new safety signals.
- B-cell depletion with SC consistent with IV; supports biologic activity.
- Phase 3 fully enrolled; top-line data expected late 2026 or early 2027; potential approval in 2028.