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 commercial-stage biopharmaceutical company focused on B-cell diseases, with news flow centered on its CD20-targeted monoclonal antibody BRIUMVI (ublituximab-xiiy) for relapsing forms of multiple sclerosis (RMS). This news page aggregates company announcements, clinical data updates, financial results, and corporate presentations related to TGTX stock.
Recent press releases highlight preliminary and reported revenue from BRIUMVI, including disclosures that product revenue consists primarily of net product sales of BRIUMVI in the United States and sales to ex-U.S. partners. Investors can follow updates on revenue guidance, operating expense targets, and commentary on how BRIUMVI commercialization influences overall company performance.
TG Therapeutics also issues frequent news about its development programs. These items include progress in the ENHANCE Phase 3b trial evaluating a simplified intravenous dosing schedule for BRIUMVI, the Phase 3 pivotal program for subcutaneous ublituximab, and the Phase 1 trial of azer-cel, an allogeneic CD19 CAR T therapy in autoimmune disease. Additional releases cover long-term ULTIMATE I & II trial data, real-world ENABLE observational study outcomes, and schedules of data presentations at neurology and multiple sclerosis congresses.
Corporate news includes participation in major healthcare and biotechnology investor conferences, rankings such as the Deloitte Technology Fast 500, and announcements of share repurchase authorizations. By following this TGTX news feed, readers can monitor how clinical results, regulatory milestones, commercialization updates, and financial disclosures intersect for TG Therapeutics and its lead therapy BRIUMVI.
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.
TG Therapeutics (NASDAQ: TGTX) presented updated 5-year data from the ULTIMATE I & II Phase 3 trials of BRIUMVI® (ublituximab-xiiy) in relapsing multiple sclerosis (RMS) at the 2024 ECTRIMS meeting. Key findings include:
- 92% of patients were free from disability progression after 5 years of BRIUMVI treatment
- Annualized relapse rate in year 5 was 0.020 (1 relapse per 50 patient-years)
- Safety profile remained consistent over 5 years with no new signals
- Patients who switched from teriflunomide to BRIUMVI saw a 58.4% reduction in relapse rate
- 17% of patients on continuous BRIUMVI achieved confirmed disability improvement
The data support BRIUMVI as a valuable long-term treatment option for RMS patients, demonstrating sustained clinical efficacy and a tolerable safety profile.
TG Therapeutics (NASDAQ: TGTX) has announced upcoming data presentations for BRIUMVI (ublituximab-xiiy) at the 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting. The presentations will highlight data from the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial, evaluating BRIUMVI in patients with relapsing forms of multiple sclerosis (RMS).
The meeting will be held from September 18-20, 2024, in Copenhagen, Denmark. Three poster presentations are scheduled, covering topics such as five-year results of ublituximab in RMS, efficacy and tolerability after transitioning from different therapies, and comparison of Multiple Sclerosis Disease Activity (MSDA) Test results between ublituximab and teriflunomide treatments.