 NEW YORK, March 29, 2021 GLOBE NEWSWIRE -- TG Therapeutics, Inc. NASDAQ: TGTX, today announced the completion of the rolling submission of a Biologics License Application BLA to the U.S. Food and Drug Administration FDA requesting approval of ublituximab, the Companys investigational glycoengineered anti-CD20 monoclonal antibody, in combination with UKONIQTM umbralisib , the Companys once-daily, oral, inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia CLL. The U.S. FDA previously granted Fast Track designation to the combination of ublituximab and umbralisib U2 for the treatment of adult patients with CLL and orphan drug designation for ublituximab in combination with umbralisib for the treatment of CLL. The BLA submission was based on the results of the UNITY-CLL trial, a global Phase 3 trial evaluating the combination of umbralisib plus ublituximab U2 compared to obinutuzumab plus chlorambucil in patients with previously untreated and relapsedrefractory chronic lymphocytic leukemia CLL. 