Farmas USA

TG Therapeutics soars 23% on positive ublituximab data in multiple sclerosis

• TG Therapeutics (NASDAQ:TGTX) jumps 23% premarket on positive topline resultsfrom two global, Phase 3 studies, called ULTIMATE I & ULTIMATE II, evaluating ublituximab, an investigational, glycoengineered anti-CD20 monoclonal antibody, compared to teriflunomide in patients with relapsing forms of multiple sclerosis (RMS).
• The ULTIMATE I & II trials enrolled a total of 1,094 patients. Both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period (p<0.005 in each trial).
• Ublituximab resulted in an ARR of <0.10 in each of ULTIMATE studies, with a relative reduction in ARR of ~60% and 50%, respectively, over teriflunomide.
• Further analyses of both the studies including safety and secondary endpoints will be presented at an upcoming medical congress, targeted in H1 2021.
• Additionally, data from these studies are intended to support a BLA submission for ublituximab in RMS targeted in mid-year 2021.
• The company will host a conference call today at 8:30 AM ET to discuss the ULTIMATE I & II topline results.