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TG Therapeutics TG Therapeutics Provides Business Update and Reports Second Quarter 2021 Financial Results August 2 , 2021 Conference call to be held today , Monday , August 2 , 2021 at 8:30 AM ET NEW YORK , Aug. 02 , 2021 ( GLOBE NEWSWIRE ) -- TG Therapeutics , Inc. ( NASDAQ : TGTX ) today announced its financial results for the second quarter ending June 30 , 2021 and recent company developments , along with a business outlook for the remainder 2021 . Michael S. Weiss , the Company's Chairman and Chief Executive Officer , stated , " We are pleased with the progress made throughout the second quarter , including our ongoing launch of UKONIQ in relapsed or refractory MZL and FL , FDA's acceptance of our BLA / sNDA for the combination of ublituximab and UKONIQ ( U2 ) to treat CLL and SLL , and the continued advancement of our clinical programs . We have built a strong commercialization infrastructure to launch UKONIQ and have received positive feedback from healthcare providers on their experiences with the product and with the TG team . We believe this solid commercialization foundation will support , if approved , the launch of U2 in CLL and ublituximab in relapsing forms of multiple sclerosis . " Mr. Weiss continued , " We look forward to an exciting second half of 2021 , during which we plan to submit a BLA for ublituximab to treat patients with relapsing forms of multiple sclerosis , continue executing on the launch of UKONIQ in MZL and FL , and continue preparations for potential commercialization of U2 in CLL and ublituximab in RMS . " 2021 Highlights & Recent Developments UKONIQⓇ ( umbralisib ) in Relapsed or Refractory Marginal Zone Lymphoma & Follicular Lymphoma • Launched UKONIQ in the U.S. for the treatment of 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 . • Generated $ 2.3M in total net UKONIQ revenue from launch through the end of Q2 2021 , approximately 4 months . • Achieved broad U.S. payor coverage for more than 90 % of Medicare and commercial lives and inclusion in the National Comprehensive Cancer Network ( NCCN ) Clinical Practice Guidelines for MZL and FL . Ublituximab plus UKONIQ ( U2 ) in Chronic Lymphocytic Leukemia • Received FDA acceptance of a Biologics License Application ( BLA ) for ublituximab and a supplemental New Drug Application ( SNDA ) for UKONIQ , both submissions requesting approval of U2 as a treatment for patients with chronic lymphocytic leukemia ( CLL ) and small lymphocytic lymphoma ( SLL ) . These applications were primarily based on results from the UNITY - CLL Phase 3 trial , which included both treatment - naïve and relapsed or refractory ( R / R ) patients . The FDA has set a Prescription Drug User Fee Act ( PDUFA ) goal date of March 25 , 2022 for both applications . • 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 R / R CLL . Ublituximab in Multiple Sclerosis • Presented positive results from the ULTIMATE I and II Phase 3 trials at the 2021 American Academy of Neurology ( AAN ) annual meeting and the 7th Congress of the European Academy of Neurology ( EAN ) . 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 • Presented updated data from TG - 1701 , our BTK inhibitor , as a monotherapy and in combination with U2 in patients with B - cell malignancies at the 2021 American Society of Clinical Oncology ( ASCO ) annual meeting , the 2021 European Hematology Association ( EHA ) virtual congress and the 16th International Congress on Malignant Lymphoma ( ICML ) . Remaining Key Objectives for 2021 and Early 2022 • Focus on the commercialization of UKONIQ in R / R MZL and FL and expand commercialization capabilities in preparation for a potential launch of U2 in CLL and ublituximab in RMS • Submit a BLA for ublituximab for the treatment of patients with RMS in Q3 2021 , based on positive results from the ULTIMATE I and II Phase 3 trials