TG Therapeutics (TGTX) has been one of the most explosive biotech stocks.
This morning, the company posted positive top-line results from two Phase 3 studies for its Ublituximab treatment of relapsing forms of multiple sclerosis (RMS). “Both studies met their primary endpoint of significantly reducing annualized relapse rate (ARR) with Ublituximab demonstrating an ARR of less than 0.10 in each of the studies,” the company said in a release.
Data from these studies are intended to support a Biologics License Application (BLA) submission for ublituximab in RMS targeted in mid-year 2021.
However, this may not be TG Therapeutics only near-term catalyst.
It’s also developing therapies that target hematological malignancies, including B-cell, non-Hodgkin’s’ lymphoma. Just recently, the company announced the publication of a Phase 2 study evaluating umbralisib, an investigational oral, dual inhibitor of PI3K-delta and CK1-epsilon, in patients with chronic lymphocytic leukemia (CLL) who are intolerant to prior BTK or PI3K-delta inhibitor therapy, in Blood, the Journal of the American Society of Hematology.