Shares of TG Therapeutics, Inc. (TGTX) are surging more than 16% Thursday morning after the company announced positive topline results from the two late stage studies of its drug candidate ublituximab in patients with relapsing forms of multiple sclerosis.
The stock touched a new high of $35.35 this morning.
The two phase III studies dubbed ULTIMATE I & II, evaluating ublituximab, a glycoengineered anti-CD20 monoclonal antibody, compared to teriflunomide in patients with relapsing forms of multiple sclerosis met their primary endpoints. Ublituximab treatment demonstrated a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period (p<0.005 in each trial).
Ublituximab treatment resulted in an ARR of <0.10 in each of ULTIMATE I & II, with a relative reduction in ARR of approximately 60% and 50%, respectively, over teriflunomide.
The studies were conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Further analyses of the ULTIMATE I & II studies including safety and secondary endpoints will be conducted and detailed data will be presented at an upcoming medical congress, in the first half of 2021, the company said.
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