Tg Therapeutics Inc - TGTX STOCK NEWS

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.

TG Therapeutics (NASDAQ: TGTX) will hold a conference call on March 2, 2021, at 8:30 AM ET to discuss the fourth quarter and year-end 2020 results and provide a business outlook for 2021. The call will be hosted by Michael S. Weiss, Executive Chairman and CEO. Interested parties can join via phone or through a live webcast on the company's website. Financial results will be announced prior to the call. TG is focused on developing novel treatments for B-cell malignancies and autoimmune diseases.

TG Therapeutics, Inc. (NASDAQ: TGTX) announced the final results of the Phase 3 GENUINE trial, published in The Lancet Haematology, which evaluated ublituximab and ibrutinib in patients with high-risk chronic lymphocytic leukemia (CLL). Results showed a 90% overall response rate in the combination therapy versus 69% for ibrutinib alone (p=0.0060). Median progression-free survival was not reached for the ublituximab group versus 35.9 months for ibrutinib. The company aims to submit a BLA for this combination to the FDA in the first half of 2021.

TG Therapeutics, Inc. (NASDAQ: TGTX) announced the FDA's approval of UKONIQ™ (umbralisib) for adult patients with relapsed or refractory marginal zone lymphoma (MZL) after one anti-CD20 therapy, and follicular lymphoma (FL) after three systemic therapies. This marks UKONIQ as the first and only oral inhibitor of PI3K-delta and CK1-epsilon for these conditions. The approval is based on Phase 2 UNITY-NHL trial data. The company is launching UKONIQ commercially, with distribution expected shortly. UKONIQ received Breakthrough Therapy Designation and orphan drug designation for both indications.

TG Therapeutics, Inc. (NASDAQ: TGTX) will participate in a fireside chat at the B. Riley Securities Oncology Investor Conference on January 20, 2021, at 10:00 AM ET. The chat will feature Michael S. Weiss, the Company’s Executive Chairman and CEO. A live webcast will be available on the Company's website with a replay accessible after the event. TG Therapeutics focuses on developing treatments for B-cell malignancies and autoimmune diseases, with key products like ublituximab and umbralisib currently in clinical development.