TG Therapeutics Says Phase 3 Briumvi Trial Met Main Goal
[출처/시간] MT Newswires - 8:29 AM ET, 05/27/2026 08:29 AM EDT, 05/27/2026 (MT Newswires) -- TG Therapeutics' (TGTX) Phase 3 ENHANCE trial met its primary endpoint, demonstrating bioequivalent drug exposure between the approved two-infusion initiation regimen for Briumvi and a proposed single Day 1 infusion dosing schedule, the company said Wednesday. The single 600 mg infusion showed comparable pharmacokinetics, safety, and MRI outcomes to the app
[출처/시간] MT Newswires - 8:29 AM ET, 05/27/2026
08:29 AM EDT, 05/27/2026 (MT Newswires) -- TG Therapeutics' (TGTX) Phase 3 ENHANCE trial met its primary endpoint, demonstrating bioequivalent drug exposure between the approved two-infusion initiation regimen for Briumvi and a proposed single Day 1 infusion dosing schedule, the company said Wednesday.
The single 600 mg infusion showed comparable pharmacokinetics, safety, and MRI outcomes to the approved Day 1 and Day 15 dosing regimen, with no new safety concerns identified, the company said.
Secondary endpoints, including MRI results and B-cell depletion, were consistent with earlier studies, while infusion-related reactions were similar across both groups and lower than in previous clinical trials.
The company said it plans to submit a supplemental biologics license application in the second half of 2026.
Shares of TG Therapeutics were up 2.8% in Wednesday premarket trading.
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