secwatch / observer

8-K filed May 27, 2026, 4:34 PM ET ticker TGTX CIK 0001001316

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.

item 8.01 item 9.01

Machine-readable event card

schema_version: secwatch.filing_event.v1
accession: 0001437749-26-018586
form_type: 8-K
ticker: TGTX
cik: 0001001316
company_name: TG THERAPEUTICS, INC.
filed_at: 2026-05-27T20:34:57+00:00
discovered_at: 2026-05-27T20:36:00.273925+00:00
generated_at: 2026-05-27T20:38:05.970465+00:00
sec_items: ["8.01", "9.01"]
event_type: other_material
sentiment: positive
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: high
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