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TG Therapeutics TG Therapeutics Provides Business Update and Reports Third Quarter 2021 Financial Results November 4 , 2021 Conference call to be held today , Thursday , November 4 , 2021 at 8:30 AM ET NEW YORK , Nov. 04 , 2021 ( GLOBE NEWSWIRE ) -- TG Therapeutics , Inc. ( NASDAQ : TGTX ) today announced its financial results for the third quarter ended September 30 , 2021 and recent company developments , along with a business outlook for the remainder of 2021 . Michael S. Weiss , the Company's Chairman and Chief Executive Officer , stated , " The third quarter of 2021 was an exciting time for us , as we achieved another major milestone by submitting a Biologics License Application ( BLA ) with the U.S. FDA for ublituximab to treat patients with relapsing forms of multiple sclerosis ( RMS ) . With an estimated 1 million Americans currently living with multiple sclerosis , we believe if approved , ublituximab will provide an attractive new treatment option for patients battling RMS , which is the most common disease course . " Mr. Weiss continued , " For the remainder of 2021 and into 2022 , we look forward to continuing to execute on the UKONIQ launch in patients with relapsed or refractory marginal zone and follicular lymphoma , and also continuing to prepare for the potential launches of ublituximab in combination with UKONIQ or U2 in CLL and ublituximab in RMS . " 2021 Highlights & Recent Developments Ublituximab in Multiple Sclerosis • Submitted a Biologics License Application ( BLA ) to the U.S. FDA for ublituximab to treat patients with relapsing forms of multiple sclerosis ( RMS ) . • Presented positive results , including new analyses , from the ULTIMATE I and II Phase 3 trials at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis ( ECTRIMS ) . As previously reported , 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 RMS . Additional secondary , tertiary and post - hoc sensitivity analyses were also presented , including T1 and T2 lesions , no evidence of disease activity ( NEDA ) , brain volume and multiple sclerosis functional composite ( MSFC ) score . Ublituximab plus UKONIQⓇ ( U2 ) in Chronic Lymphocytic Leukemia • Received FDA acceptance of a 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 based on results from the UNITY - CLL Phase 3 trial , which included both treatment - naïve and relapsed or refractory ( R / R ) CLL 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 Phase 2 portion of the ULTRA - V trial and launched the Phase 3 portion of the ULTRA - V trial , a randomized trial evaluating the triple combination of U2 plus venetoclax in patients with treatment - naïve and R / R CLL . • Presented updated results from the Phase 1 trials of U2 plus venetoclax evaluating patients with R / R CLL at the 2021 International Workshop on Chronic Lymphocytic Leukemia ( iwCLL ) . 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 $ 4.3M in total net UKONIQ revenue from launch through the end of Q3 2021 , approximately seven months . • Achieved broad U.S. payor coverage for more than 95 % of Medicare and commercial lives and inclusion in the National Comprehensive Cancer Network ( NCCN ) Clinical Practice Guidelines for MZL and FL . • Published results from an integrated safety analysis of UKONIQ in Blood Advances . TG - 1701 in B - cell Malignancies • Presented updated data from TG - 1701 , our bruton tyrosine kinase ( BTK ) inhibitor , as a monotherapy and in combination with U2 in patients with B - cell malignancies at the 2021 iwCLL meeting . Remaining Key Objectives for 2021 and Early 2022