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TG Therapeutics Announces Positive Data From BRIUMVI Study, Initiates Phase 2 Trial; Stock Gains

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us

Tuesday, TG Therapeutics, Inc. (TGTX) announced positive topline Phase 1 data for BRIUMVI in patients with myasthenia gravis, a chronic autoimmune neuromuscular disease.

At Week 24, 82 per cent of patients who received BRIUMVI achieved the Minimal Clinically Important Difference in MG-ADL, with a mean improvement of 4.6 points.

Moreover, consistent reductions from baseline were observed across all myasthenia gravis outcome measures over time following treatment with subcutaneous BRIUMVI

Also, the company announced the commencement of Phase 2 trial to evaluate the efficacy and safety of BRIUMVI in maintaining clinical response in patients with myasthenia gravis who initially respond to treatment with the FcRn inhibitor efgartigimod.

The trial, expected to enroll about 120 patients, will initially utilize the approved intravenous BRIUMVI dosing regimen, with subcutaneous BRIUMVI administration to be incorporated at a later stage following completion of pharmacokinetic bridging studies currently underway in multiple sclerosis.

Following completion of the randomized period, all patients will be eligible to enter a 72-week open-label extension evaluating treatment with BRIUMVI.

Currently, TGTX is trading at $42.51, up 3.81 percent on the Nasdaq.

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