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TG Therapeutics TG Therapeutics Provides Business Update and Reports First Quarter 2021 Financial Results May 10 , 2021 Conference call to be held today , Monday , May 10 , 2021 at 8:30 AM ET NEW YORK , May 10 , 2021 ( GLOBE NEWSWIRE ) -- TG Therapeutics , Inc. ( NASDAQ : TGTX ) today announced its financial results for the first quarter ending March 31 , 2021 and recent company developments , along with a business outlook for 2021 . Michael S. Weiss , the Company's Executive Chairman and Chief Executive Officer , stated , " 2021 has been an incredibly impactful year , kicking off with our first approval coming ahead of schedule for UKONIQ to treat both relapsed or refractory Marginal Zone Lymphoma and Follicular Lymphoma . That was followed by the completion of a BLA submission for ublituximab in combination with UKONIQ ( U2 ) to treat patients with CLL , and the full presentation of positive results from the ULTIMATE I & II Phase 3 trials in relapsing forms of MS . As a fully integrated commercial organization we are pleased with our progress thus far with the UKONIQ launch and we look forward to continuing to build our commercial infrastructure to support the potential approval and commercialization of U2 in CLL and ublituximab in RMS . " 2021 Highlights & Recent Developments UKONIQ ™ ( umbralisib ) in Relapsed or Refractory Marginal Zone Lymphoma & Follicular Lymphoma • Received accelerated approval from the U.S. Food and Drug Administration ( FDA ) on February 5 , 2021 for UKONIQ to treat adult patients with relapsed or refractory marginal zone lymphoma ( MZL ) who have received at least one prior anti - CD20 based regimen and adult patients with relapsed or refractory follicular lymphoma ( FL ) who have received at least three prior lines of systemic therapy . • Launch efforts underway across the U.S. UKONIQ has payor coverage for 85-90 % of Medicare and commercial lives and is included in the National Comprehensive Cancer Network ( NCCN ) Clinical Practice Guidelines for MZL and FL , consistent with the FDA - approved indications . • Published results from the UKONIQ monotherapy cohorts of the UNITY - NHL Phase 2b trial in patients with relapsed or refractory indolent non - Hodgkin Lymphoma ( NHL ) in the Journal of Clinical Oncology . Ublituximab plus UKONIQ ( U2 ) in Chronic Lymphocytic Leukemia • Completed a rolling submission of a Biologics License Application ( BLA ) to the FDA requesting approval of U2 , as a treatment for patients with chronic lymphocytic leukemia ( CLL ) , including both previously untreated and relapsed / refractory patients , based on the positive results from the UNITY - CLL Phase 3 trial . • Completed enrollment in the ULTRA - V Phase 2 trial , and launched the ULTRA - V Phase 3 randomized trial evaluating the triple combination of U2 plus venetoclax in patients with treatment naïve and relapsed or refractory CLL . Ublituximab in Multiple Sclerosis • Presented positive results from the ULTIMATE I & II Phase 3 trials at the American Academy of Neurology 2021 Annual Meeting . Both trials met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate ( ARR ) over a 96 - week period compared to teriflunomide in patients with relapsing forms of multiple sclerosis ( RMS ) . TG - 1701 in B - cell Malignancies • Updated data from TG - 1701 , our BTK inhibitor , as a monotherapy and in combination with U2 in patients with B - cell malignancies has been accepted for presentation at the American Society of Clinical Oncology ( ASCO ) annual meeting being held in June 2021 . Remaining Key Objectives for 2021 • Focus on the commercialization of UKONIQ in relapsed / refractory MZL and FL and expand commercialization capabilities in preparation for a potential launch of U2 for CLL and ublituximab in MS • Submit a BLA for ublituximab for the treatment of patients with RMS in Q3 2021 , based on positive results from the ULTIMATE I & II Phase 3 trials • Receive notification from the FDA that the BLA for U2 in CLL has been accepted for filing and work closely with the Agency on its review of the application • Enroll into the newly launched ULTRA - V Phase 3 trial evaluating the triple combination of U2 plus venetoclax