TG Therapeutics (TGTX) - Get Report soared Thursday after the biopharma announced positive results from two global Phase 3 studies, evaluating ublituximab, the company's treatment of multiple sclerosis patients.
Shares of the New York-based company were skyrocketing nearly 42% to $42.04 in trading Thursday.
Both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period, the company said.
The studies were conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration.
Ublituximab treatment resulted in an ARR of less than 0.10 in each study, with a relative reduction in ARR of about 60% and 50%, respectively, over teriflunomide.
"If approved, ublituximab has the potential to offer patients a one-hour infusion, which we believe will be an attractive option for many patients with MS," said Michael Weiss, executive chairman and CEO, in a statement. "With more than 1 million Americans estimated to be living with MS today, there continues to be a need for efficacious and convenient treatment options."
"We look forward to a detailed presentation of the data at a major medical meeting in the first half of 2021 once the full data are analyzed, as well as completing a BLA (Biologics License Applications) submission targeted for mid-next year,” Weiss said.
TG Therapeutics company also is developing therapies targeting hematological malignancies, including B-cell, non-Hodgkins lymphoma.