Benzinga | May 25, 2021 07:01AM EDT

TG Therapeutics Announces FDA Acceptance Of Biologics License Application For Ublituximab In Combination With UKONIQ As Treatment For Patients With Chronic Lymphocytic Leukemia And Small Lymphocytic Lymphoma

TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for ublituximab, the Company's investigational glycoengineered anti-CD20 monoclonal antibody, in combination with UKONIQ(r) (umbralisib), the Company's once-daily, oral, inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2022. The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss this application.