TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the presentation of data from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 American Academy of Neurology (AAN) annual meeting, being held in Denver. Two additional presentations will be shared on Wednesday April 17.
CEO Michael S. Weiss, stated “The ULTIMATE I & II Phase 3 trials demonstrated robust clinical activity for BRIUMVI compared to teriflunomide and these post-hoc analyses provide interesting new insights and support BRIUMVI’s utility as an important treatment option for patients with relapsing forms of multiple sclerosis. We look forward to presenting two additional data sets this week during the AAN annual meeting.”
ULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI.
TGTX shares gained 25 cents, or 1.8%,to $14.41.
