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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) presented data for BRIUMVI® (ublituximab-xiiy) in treating relapsing forms of multiple sclerosis (RMS) at the American Academy of Neurology 2025 annual meeting. The ENHANCE trial demonstrated that a single 600 mg dose of BRIUMVI on Day 1 was well-tolerated, leading the company to consider a registration-directed trial to combine the currently approved Day 1 and Day 15 doses into a single administration.
Two key presentations were featured:
- Efficacy and Safety of Modified Ublituximab Regimen (ENHANCE) by Dr. John Foley
- Five-year Ublituximab results in Relapsing Multiple Sclerosis from ULTIMATE I and II Studies' open-label extension by Dr. Bruce Cree
TG Therapeutics (NASDAQ: TGTX) presented three significant data sets for BRIUMVI® (ublituximab-xiiy) in treating relapsing forms of multiple sclerosis (RMS) at the American Academy of Neurology 2025 annual meeting.
Key findings include:
- The ENAMOR survey, covering ~400 patients across 21 MS centers, showed improved tolerability and lower infusion-related reactions compared to Phase 3 trials
- 90% of surveyed patients received acetaminophen pre-medication, potentially explaining the better tolerance rates
- The company announced ENABLE, a new Phase 4 96-week observational study, which will track approximately 500 patients across 100 US MS centers
- Five-year BRIUMVI treatment data showed consistent serious infection rates with Phase 3 trials and no Progressive Multifocal Leukoencephalopathy (PML) cases
TG Therapeutics (NASDAQ: TGTX) has announced the publication of two significant journal articles focusing on BRIUMVI® (ublituximab-xiiy) in multiple sclerosis (MS) treatment. The first publication in Frontiers in Immunology presents a case series of seven MS patients who switched to BRIUMVI from other anti-CD20 therapies due to efficacy or tolerability issues.
The second article, published in CNS DRUGS, examines the evolution of anti-CD20 treatments for MS, discussing key characteristics such as scaffold, mechanism of action, and Fc engineering that may influence therapeutic efficacy and patient experience.
Michael S. Weiss, Executive Chairman and CEO, emphasized these publications provide rationale for switching patients within the CD20 class before abandoning it entirely. The company continues to study this phenomenon through their ongoing ENHANCE and ENABLE studies to further validate these initial findings.
TG Therapeutics (NASDAQ: TGTX) has announced upcoming presentations featuring BRIUMVI® (ublituximab-xiiy) data for relapsing multiple sclerosis (RMS) at the American Academy of Neurology 2025 annual meeting in San Diego (April 5-9, 2025).
The presentations include five poster sessions focusing on:
- Long-term ublituximab treatment's impact on immunoglobulin levels and serious infections
- Real-world infusion tolerability (ENAMOR survey)
- ENABLE Phase 4 observational study
- Five-year results from ULTIMATE I and II studies' open-label extension
- Modified ublituximab regimen (ENHANCE) efficacy and safety
Key researchers presenting include Dr. Bruce Cree from UC San Francisco's Weill Institute for Neurosciences, Dr. Ed Fox from TG Therapeutics, and Dr. John Foley from Rocky Mountain Multiple Sclerosis.
TG Therapeutics (NASDAQ: TGTX) reported strong financial results for Q4 and full year 2024, with BRIUMVI U.S. net revenue reaching $103.6 million in Q4 and $310 million for the full year, marking approximately 250% growth year-over-year.
Key highlights include:
- Target guidance of $540 million in total global revenue for 2025
- Extended BRIUMVI patent protection through 2042
- Successful European launch with partner Neuraxpharm
- Impressive 5-year clinical data showing 92% of patients free from disability progression
The company reported net income of $23.3 million for Q4 2024 and $23.4 million for the full year. Cash position stands at $311.0 million as of December 31, 2024. R&D expenses increased to $94.3 million for 2024, while SG&A expenses rose to $154.3 million, primarily due to BRIUMVI commercialization efforts.
TG Therapeutics (NASDAQ: TGTX) presented data from multiple studies of BRIUMVI® (ublituximab-xiiy) for relapsing multiple sclerosis (RMS) at the ACTRIMS annual forum. The presentations included:
1. Updated results from the ENHANCE Phase 3b trial showing consistent safety and tolerability in over 80 patients receiving 30-minute maintenance BRIUMVI doses
2. A real-world retrospective chart review by Dr. John Foley examining over 160 BRIUMVI-treated patients, confirming safety profiles consistent with ULTIMATE I & II Phase 3 trials and noting improvements in patients with suboptimal responses to prior anti-CD20 therapies
3. Additional presentations on Fc Biology and Genetic Diversity study design, and disease activity trajectories comparison between ublituximab and teriflunomide in ULTIMATE trials
TG Therapeutics (NASDAQ: TGTX) has scheduled a conference call for Monday, March 3, 2025, at 8:30 AM ET to discuss their fourth quarter and full year 2024 financial results, along with providing a business outlook for 2025.
The call will be hosted by Michael S. Weiss, Chairman and Chief Executive Officer. Participants can join via phone using the following numbers:
- U.S.: 1-877-407-8029
- Outside U.S.: 1-201-689-8029
A live webcast will be available on the Events page in the Investors & Media section of www.tgtherapeutics.com, with an audio recording accessible for 30 days after the call. Financial results will be released via press release before the call.
TG Therapeutics (NASDAQ: TGTX) has announced upcoming presentations of BRIUMVI® (ublituximab-xiiy) data at the ACTRIMS annual forum, scheduled for February 27 – March 1, 2025, in West Palm Beach, Florida. The presentations will showcase results from the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial in patients with relapsing forms of multiple sclerosis (RMS).
Four poster presentations are scheduled, including studies on: the safety and tolerability of 30-minute ublituximab infusions from the ENHANCE study; Fc biology and genetic diversity in multiple sclerosis; real-world ublituximab experience at a US MS center; and disease activity trajectories comparing ublituximab and teriflunomide in ULTIMATE I and II trials.
TG Therapeutics (TGTX) announced preliminary Q4 and full-year 2024 results for BRIUMVI®, reporting strong U.S. net product revenue of $103.6 million and $310 million respectively. The company projects ambitious 2025 targets, including total global revenue of approximately $540 million, with BRIUMVI U.S. net product revenue expected to reach $525 million.
With a year-end 2024 cash position of approximately $310 million, TG Therapeutics plans significant development initiatives for 2025, including launching pivotal programs for subcutaneous BRIUMVI administration and optimizing intravenous dosing. The company targets operating expenses of approximately $300 million for 2025 and plans to expand BRIUMVI's evaluation in autoimmune diseases beyond Multiple Sclerosis.
TG Therapeutics (NASDAQ: TGTX) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The company's Chairman and CEO, Michael S. Weiss, is scheduled to deliver a presentation on Monday, January 13, 2025, at 4:30 PM PT.
Investors and interested parties can access a live webcast of the presentation through the Events page in the Investors & Media section of TG Therapeutics' website. For those unable to attend the live presentation, a replay will be made available on the company's website following the event.
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