Business
TG Therapeutics Provides Business Update and Reports Third Quarter 2021 Financial Results
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)
About this update from Tg Therapeutics, Inc.
[{"type":"text","content":"Conference call to be held today, Thursday, November 4, 2021 at 8:30 AM ET\nNEW 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...