Welcome to our dedicated page for TG Therapeutics news (Ticker: TGTX), a resource for investors and traders seeking the latest updates and insights on TG Therapeutics stock.
TG Therapeutics develops and commercializes therapies for B-cell diseases, with news centered on BRIUMVI (ublituximab-xiiy), its anti-CD20 monoclonal antibody for adult patients with relapsing forms of multiple sclerosis. Company updates commonly cover U.S. net product revenue, global revenue targets, commercial demand, and international commercialization economics tied to BRIUMVI.
Recurring developments also include clinical and real-world data for BRIUMVI in relapsing multiple sclerosis, presentations and publications from multiple sclerosis studies, and development work on a subcutaneous formulation. Corporate news includes financing arrangements, share repurchase authorization updates, operating-expense guidance, and business outlook commentary alongside quarterly and annual results.
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.
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 submission targeted for mid-2021. The studies enrolled 1,094 patients globally and were conducted under FDA's Special Protocol Assessment.