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Overview of TG Therapeutics Inc
TG Therapeutics Inc (NASDAQ: TGTX) is a specialized biopharmaceutical company dedicated to the acquisition, development, and commercialization of innovative therapies for B-cell diseases, including hematologic malignancies and autoimmune disorders. The company leverages advanced technologies such as glycoengineering to create optimized monoclonal antibodies that target critical cellular antigens and signaling pathways. Key products under development incorporate deep scientific insights into B-cell biology and have been designed to improve patient outcomes by providing more efficient and targeted treatments.
Core Therapeutic Areas and Pipeline Focus
TG Therapeutics is at the forefront of developing therapies targeting B-cell malignancies and autoimmune conditions. Its leading candidate, a glycoengineered monoclonal antibody designated TG-1101 (also known by its commercial name BRIUMVI), is engineered to target a unique epitope on the CD20 antigen. This specificity aids in the efficient depletion of mature B-lymphocytes, a critical aspect in the treatment of relapsing forms of multiple sclerosis (RMS) and potentially other autoimmune disorders. Additionally, the company is advancing TG-1202, an orally available PI3K delta inhibitor, to address the proliferation and survival of B-cells, particularly in the realm of hematologic disorders.
Development Strategy and Commercial Operations
Operating as a fully integrated commercial stage company, TG Therapeutics actively manages a diverse portfolio that spans late-stage clinical trials to preclinical research. Their robust pipeline is designed to address unmet medical needs in critical patient segments. Emphasizing both rigorous clinical development and strategic commercialization, the company has secured approvals in key markets and is expanding its footprint via collaborations and a dedicated infrastructure to ensure effective market delivery. The company also pursues additional targets, including inhibitors aimed at modulating key inflammatory pathways, thereby reinforcing its commitment to innovation.
Industry Position and Competitive Landscape
TG Therapeutics differentiates itself through a deep expertise in antibody engineering and a focus on novel mechanisms of action. By addressing the challenges inherent in B-cell targeted therapies and autoimmune treatments, the company competes with other biopharmaceutical firms by demonstrating a detailed understanding of immune modulation. Its clinical development programs, backed by comprehensive research and regulatory milestones, position it as a valuable and insightful contributor in the competitive biotechnology arena.
Commitment to Scientific Excellence and Transparency
The company's scientific approach is characterized by a clear, data-driven evaluation of its therapeutic candidates and a commitment to continual improvement. Transparent reporting of clinical trial designs, outcomes, and safety profiles underpins its reputation for expertise and trustworthiness. TG Therapeutics provides comprehensive information that aids healthcare professionals, researchers, and investors in understanding its innovative approach and detailed product profiles without resorting to speculative claims.
Conclusion
For professionals seeking an in-depth understanding of a biopharmaceutical company driven by novel research in B-cell diseases, TG Therapeutics offers a wealth of expertise. Its strategic focus on integrating cutting-edge science with efficient commercialization practices makes it an important entity in the evolving landscape of treatments for hematologic malignancies and autoimmune disorders.
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 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.
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