TG Therapeutics, Inc. - TGTX STOCK NEWS

Samsung Biologics and TG Therapeutics have expanded their contract manufacturing partnership for ublituximab, an investigational anti-CD20 monoclonal antibody. TG Therapeutics has submitted a Biologics License Application (BLA) to the FDA for ublituximab combined with UKONIQ for chronic lymphocytic leukemia (CLL) treatment, following positive Phase 3 trial results. Samsung is also building its largest biomanufacturing facility, set to boost global capacity. Ublituximab results from advanced glycoengineering aimed at enhancing treatment efficacy against B-cell malignancies.

TG Therapeutics (TGTX) has completed patient enrollment in the ULTRA-V Phase 2 trial and is initiating the ULTRA-V Phase 3 trial for patients with chronic lymphocytic leukemia (CLL). The Phase 3 trial will evaluate a triple combination therapy of UKONIQ™, ublituximab, and venetoclax. The primary endpoint is Progression-free Survival (PFS). Approximately 165 patients have been enrolled in the Phase 2 trial. The company looks forward to presenting Phase 2 results at future medical meetings, with further development and regulatory plans hinging on these outcomes.

TG Therapeutics announced positive results from its Phase 3 trials, ULTIMATE I & II, for ublituximab versus teriflunomide in relapsing multiple sclerosis (RMS). Ublituximab showed a statistically significant reduction in annualized relapse rates, achieving a 60% reduction in ULTIMATE I (ARR: 0.076 vs. 0.188) and 50% reduction in ULTIMATE II (ARR: 0.091 vs. 0.178). MRI results revealed a 97% reduction in enhancing lesions. Ublituximab was well tolerated, with plans for a BLA submission in Q3 2021.

TG Therapeutics (NASDAQ: TGTX) has scheduled a webcast for April 16, 2021, at 8:30 AM ET for the American Academy of Neurology (AAN) Annual Meeting. The event will discuss the ULTIMATE I & II Phase 3 trials of ublituximab for treating relapsing multiple sclerosis (RMS). Results indicate a statistically significant reduction in annualized relapse rates, supporting a Biologics License Application (BLA) submission targeted for mid-2021. The ULTIMATE trials enrolled 1,094 patients across 10 countries and met primary endpoints with promising efficacy results.

TG Therapeutics, Inc. (NASDAQ: TGTX) has completed the rolling submission of a Biologics License Application (BLA) to the FDA for ublituximab and UKONIQ (umbralisib) as a treatment for chronic lymphocytic leukemia (CLL). This submission follows the results of the UNITY-CLL Phase 3 trial, which met its primary endpoint of superior progression-free survival. The FDA has granted Fast Track and orphan drug designations for this combination therapy. TG Therapeutics aims to expedite the approval process and bring this therapy to patients with CLL as quickly as possible.

TG Therapeutics, Inc. (NASDAQ: TGTX) announced the publication of results from the UNITY-NHL Phase 2b trial in the Journal of Clinical Oncology, evaluating UKONIQ™ (umbralisib) for relapsed or refractory indolent non-Hodgkin Lymphoma (iNHL). The trial showed an overall response rate (ORR) of 47.1% among 208 patients. For marginal zone lymphoma, ORR was 49.3%, while follicular lymphoma had an ORR of 45.3%. The safety profile was manageable, with notable adverse events including neutropenia (11.5%) and diarrhea (10.1%). UKONIQ is now FDA-approved for specific lymphoma treatments.

TG Therapeutics announced that the results of the Phase 3 trials, ULTIMATE I & II, evaluating ublituximab for relapsing forms of multiple sclerosis (RMS), will be presented at the American Academy of Neurology meeting from April 17-22, 2021. The trials included 1,094 patients and showed a statistically significant reduction in annualized relapse rate (ARR) over 96 weeks, achieving an ARR of less than 0.10. The company plans to submit a Biologics License Application (BLA) for ublituximab by mid-2021.

TG Therapeutics (NASDAQ: TGTX) announced that Michael S. Weiss, Executive Chairman and CEO, will present at the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. The presentation will be available for on-demand download starting March 9 at 7:00 AM ET. A replay can be accessed on the Company’s Events page in the Investors & Media section of its website.

TG Therapeutics focuses on innovative therapies for B-cell malignancies and autoimmune diseases, with multiple investigational medicines and FDA-approved treatments like UKONIQ™ for specific lymphoma types.

TG Therapeutics (NASDAQ: TGTX) reported its financial results for Q4 and full-year 2020, achieving significant regulatory milestones. The FDA granted accelerated approval for UKONIQ in relapsed/refractory marginal zone lymphoma (MZL) and follicular lymphoma (FL). The company initiated a rolling BLA submission for ublituximab in combination with umbralisib for chronic lymphocytic leukemia (CLL), with key Phase 3 trial results demonstrating improved progression-free survival. Despite a net loss of $279.4 million for 2020, TG ended the year with over $600 million in cash, supporting operations into 2023.