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8-KAccepted May 27, 4:34 PM ET

TG Therapeutics Announces Positive Phase 3 Topline Results for BRIUMVI

TGTXTG THERAPEUTICS, INC.

Accepted (ET)

4:34 PM

May 27, 2026

Filed

May 27, 2026

Documents

13

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213.7 KB

Summary

TG Therapeutics Announces Positive Phase 3 Topline Results for BRIUMVI

Updated

What Happened

  • TG Therapeutics, Inc. (TGTX) announced on May 27, 2026 that it reported positive topline results from the Phase 3 ENHANCE trial. The randomized, double‑blind study evaluated a consolidated single‑infusion regimen for initiation of BRIUMVI (ublituximab‑xiiy) in adults with relapsing forms of multiple sclerosis (RMS). The company filed a press release disclosing these results and included it as Exhibit 99.1 in the Form 8‑K.

Key Details

  • Trial: Phase 3 ENHANCE, randomized, double‑blind.
  • Drug: BRIUMVI (ublituximab‑xiiy); regimen tested: consolidated single‑infusion initiation.
  • Population: adults with relapsing forms of multiple sclerosis (RMS).
  • Disclosure: Press release dated May 27, 2026 was filed as Exhibit 99.1 to the Form 8‑K.

Why It Matters

  • Positive Phase 3 topline results are a major clinical milestone for a late‑stage program and are material information for investors following TG Therapeutics’ MS franchise.
  • The filing notifies the market that the company has achieved the stated topline outcome; investors should watch for the full data release, detailed trial results, and any company guidance on next regulatory or clinical steps that may follow.

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