TG Therapeutics, Inc. - TGTX STOCK NEWS

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.

TG Therapeutics has announced that CEO Michael S. Weiss will present at the 39th Annual J.P. Morgan Healthcare Conference on January 12, 2021, at 2:00 PM ET. The event will be held virtually, allowing investors to access a live webcast via the company's website. TG Therapeutics focuses on developing treatments for B-cell malignancies and autoimmune diseases, with products like ublituximab and umbralisib in advanced clinical trials.

TG Therapeutics, Inc. (NASDAQ: TGTX) announced its underwritten public offering of 6,320,000 shares of common stock at $43.50 per share, aiming for gross proceeds of approximately $275 million before expenses. The offering size was increased from the previously announced $200 million. The proceeds will fund the development of ublituximab and umbralisib, acquire new pharmaceutical products, and cover general corporate expenses. Closing is expected on December 17, 2020, pending customary conditions.

TG Therapeutics, Inc. (NASDAQ: TGTX) has announced an underwritten public offering of $200 million of its common stock, with an additional $30 million option for underwriters. The proceeds will be used for the development of ublituximab and umbralisib, potential acquisitions, and general corporate purposes. The offering is subject to market conditions and follows a shelf registration statement filed with the SEC. J.P. Morgan, Goldman Sachs, Evercore, and Cantor Fitzgerald are the joint book-running managers for this offering.

TG Therapeutics announced positive topline results from two Phase 3 studies, ULTIMATE I & II, evaluating ublituximab for patients with relapsing forms of multiple sclerosis (RMS). Both studies significantly reduced annualized relapse rate (ARR) to <0.10, with relative reductions of approximately 60% and 50% compared to teriflunomide (p<0.005). Ublituximab's safety and efficacy will support a Biologics License Application (BLA) submission targeted for mid-2021. The studies enrolled 1,094 patients globally and were conducted under FDA's Special Protocol Assessment.

TG Therapeutics (TGTX) announces promising results from the UNITY-CLL and UNITY-NHL clinical trials presented at the ASH 2020 meeting. The U2 combination therapy significantly improved progression-free survival (PFS) in CLL patients, showing a hazard ratio of 0.54 (p<0.0001). In the UNITY-NHL trial, umbralisib monotherapy achieved an overall response rate (ORR) of 49.3% in MZL patients. Both therapies displayed manageable safety profiles with low incidence of severe adverse events. The company plans to submit regulatory applications, with deadlines set for early 2021.

TG Therapeutics (TGTX) revealed promising data from two triple therapy combinations for treating relapsed or refractory chronic lymphocytic leukemia (CLL) at the 62nd ASH annual meeting. A combination of umbralisib, ublituximab, and venetoclax (U2-Ven) demonstrated a 100% overall response rate (ORR) at cycle 12, with a 41% complete response (CR) rate. Additionally, U2 combined with TG-1701 showed a 79% ORR and a 22% CR rate. The trials highlight TGTX's commitment to advancing treatments for B-cell malignancies, potentially leading to better patient outcomes.