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, Inc. (NASDAQ: TGTX) is a biopharmaceutical company headquartered in New York City, dedicated to developing and commercializing innovative treatments for B-cell malignancies and autoimmune diseases. The company has a rich pipeline of products aimed at addressing unmet medical needs in these areas.
One of TG Therapeutics' flagship products is BRIUMVI® (ublituximab-xiiy), a novel monoclonal antibody targeting CD20-expressing B-cells. BRIUMVI is FDA-approved for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The company has also received approval from the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of RMS in Europe and the United Kingdom, respectively.
In addition to BRIUMVI, TG Therapeutics is advancing several other therapies:
- TG-1701 (BTK inhibitor)
- TG-1801 (anti-CD47/CD19 bispecific mAb)
Recent company news highlights the robust clinical activity of BRIUMVI, as demonstrated in the ULTIMATE I & II Phase 3 trials, and the company’s ongoing commitment to the multiple sclerosis community. TG Therapeutics has also been awarded a national contract with the Department of Veterans Affairs (VA) to list BRIUMVI as the preferred agent on the VA National Formulary for Anti-CD20 Antibody indications.
Financially, TG Therapeutics reported strong first-quarter 2024 sales, with BRIUMVI U.S. net revenue exceeding $50 million, leading to revised annual guidance of $270 to $290 million for 2024. The company is focused on expanding its commercial infrastructure and advancing its research pipeline, including developing a subcutaneous form of BRIUMVI and moving the therapy into additional indications beyond MS.
For more information, visit the company’s website at www.tgtherapeutics.com.
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.
TG Therapeutics (NASDAQ: TGTX) has announced its participation in the 7th Annual Evercore HealthCONx Conference. The event will be held at the Loews Coral Gables Hotel in Florida from December 3-5, 2024. Michael S. Weiss, the Company's Chairman and CEO, will participate in a fireside chat on Tuesday, December 3, at 10:00 AM ET. Interested parties can access a live webcast of the discussion through the Events page in the Investors & Media section of the company's website.
TG Therapeutics (NASDAQ: TGTX) has been ranked number one on the 2024 Deloitte Technology Fast 500™, which recognizes the fastest-growing companies in North America across technology, media, telecommunications, life sciences, fintech, and energy tech sectors. The company's exceptional growth between fiscal years 2020-2023 was driven by BRIUMVI® revenues, their multiple sclerosis treatment approved in December 2022 for adult patients with relapsing forms of the disease.
TG Therapeutics reported strong Q3 2024 financial results with BRIUMVI net revenue of $83.3 million, representing 15% quarter-over-quarter growth and 230% year-over-year increase. The company raised its full-year 2024 BRIUMVI revenue guidance to $300-305 million. Clinical data showed impressive 5-year results with 92% of patients free from disability progression and an annualized relapse rate of 0.02. The company secured FUJIFILM Diosynth as a secondary US manufacturer and reported Q3 net income of $3.9 million with a strong cash position of $341 million.
TG Therapeutics (NASDAQ: TGTX) has scheduled a conference call for Monday, November 4, 2024, at 8:30 AM ET to discuss their third quarter 2024 financial results and provide a business outlook. The call will be hosted by Chairman and CEO Michael S. Weiss. Financial results will be released before the call. Participants can join via phone (1-877-407-8029 U.S., 1-201-689-8029 international) or watch the live webcast on the company's website. An audio recording will be available for 30 days after the call.
TG Therapeutics (NASDAQ: TGTX) presented updated data from the ENHANCE Phase 3b trial of BRIUMVI® (ublituximab-xiiy) for relapsing forms of multiple sclerosis (RMS) at the 2024 ECTRIMS meeting. Key findings include:
1. Patients switching from prior anti-CD20 treatment can successfully eliminate the initial BRIUMVI infusion.
2. Rapid 30-minute BRIUMVI infusions are well-tolerated, with only mild (Grade 1) infusion-related reactions.
3. 97% of 1-hour infusions for B-cell depleted patients were completed without interruption.
4. 12 patients received 30-minute infusions at week 24, all completed without interruption.
The company aims to improve patient tolerability and convenience, potentially leading to label-enabling studies for optimized dosing regimens.
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