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 announced the FDA approval of BRIUMVI (ublituximab-xiiy) for treating relapsing forms of multiple sclerosis in adults. This marks the first anti-CD20 monoclonal antibody approved for this indication, allowing for a biannual infusion schedule after a starting dose. Clinical trials ULTIMATE I & II demonstrated significant efficacy over teriflunomide by reducing the annualized relapse rate and lesion count. A commercial launch is anticipated in Q1 2023, with TG Therapeutics expressing commitment to patient access.
TG Therapeutics (TGTX) announced its Q3 2022 financial results, reporting a net loss of $35.8 million compared to $85.6 million in Q3 2021. R&D expenses decreased to $20.8 million from $52.0 million year-over-year, primarily due to cost-savings measures. SG&A expenses also fell to $14.3 million from $34.9 million. The FDA accepted the Biologics License Application for ublituximab, with a PDUFA goal date set for December 28, 2022. The company maintains a cash position of $197.7 million, sufficient to support operations into 2024.
TG Therapeutics (NASDAQ: TGTX) will host a conference call on November 10, 2022, at 8:30 AM ET to discuss its third-quarter 2022 results. The call will be led by Michael S. Weiss, Chairman and CEO. Interested parties can participate by calling 1-877-407-8029 (U.S.) or 1-201-689-8029 (international). A live webcast will be available on TG Therapeutics' website, and a recording will be accessible for up to 30 days post-call. The company focuses on developing treatments for B-cell diseases and has completed a Phase 3 program for ublituximab.
TG Therapeutics (NASDAQ: TGTX) announced significant findings from the ULTIMATE I & II Phase 3 trials of ublituximab for treating relapsing forms of multiple sclerosis (RMS) at the 2022 ECTRIMS annual meeting. These trials demonstrated a statistically significant reduction in annualized relapse rate compared to teriflunomide. CEO Michael S. Weiss expressed optimism ahead of the upcoming PDUFA goal date on December 28, 2022. The trials involved 1,094 patients across 10 countries, showcasing ublituximab's potential efficacy and safety for RMS patients.
TG Therapeutics (TGTX) announced the presentation of data from the ULTIMATE I & II Phase 3 trials of ublituximab for relapsing multiple sclerosis at the ECTRIMS annual meeting on October 26-28, 2022. Key presentations include comparisons of disability changes and functional scores between ublituximab and teriflunomide. Ublituximab demonstrated a significant reduction in annualized relapse rate (ARR) over 96 weeks, meeting its primary endpoint. The trials enrolled 1,094 patients across 10 countries under FDA's Special Protocol Assessment.
TG Therapeutics (NASDAQ: TGTX) announced that CEO Michael S. Weiss will participate in a virtual fireside chat at the H.C. Wainwright Global Investment Conference from September 12-14, 2022. The chat will be available for on-demand download starting September 12, 2022, at 7:00 AM ET on the conference website and TG's website. TG Therapeutics focuses on developing novel treatments for B-cell diseases, including a Phase 3 program for ublituximab for relapsing forms of multiple sclerosis.
TG Therapeutics announced results from the ULTIMATE I and II Phase 3 trials demonstrating the efficacy of ublituximab for treating relapsing forms of multiple sclerosis (RMS). Compared to teriflunomide, ublituximab showed a significantly lower annualized relapse rate (ARR) of 0.08 vs. 0.19 in ULTIMATE I, and 0.09 vs. 0.18 in ULTIMATE II (p<0.001). The drug potentially offers a unique treatment option with a one-hour infusion every six months. The FDA and EMA are reviewing its marketing application, with a decision expected by December 28, 2022.
TG Therapeutics (NASDAQ: TGTX) has announced a conference call scheduled for August 8, 2022, at 8:30 AM ET to discuss its second-quarter financial results. The call will be led by Michael S. Weiss, Executive Chairman and CEO. A press release detailing the financial results will be issued before the call. Participants can join the call by dialing 1-877-407-8029 (U.S.) or 1-201-689-8029 (international). A live webcast and audio recording of the call will be available on the company's website for 30 days post-event.
TG Therapeutics (TGTX) announced positive findings from pooled analyses of its ULTIMATE I & II Phase 3 trials of ublituximab for relapsing forms of multiple sclerosis (RMS). Presented at the 8th Congress of the European Academy of Neurology, results indicated a significant reduction in annualized relapse rates. The company sets a goal for FDA approval by December 28, 2022. The ULTIMATE trials involved 1,094 patients across 10 countries, showing substantial efficacy over teriflunomide, a common treatment.
TG Therapeutics (TGTX) announced multiple data presentations at the CMSC annual meeting, showcasing findings from the Phase 3 ULTIMATE I & II trials assessing ublituximab for relapsing multiple sclerosis (RMS). The data reinforces previous positive results, reporting a statistically significant reduction in annualized relapse rate (ARR) compared to teriflunomide. The trials involved 1,094 patients across 10 countries and demonstrated promising efficacy and safety profiles. CEO Michael Weiss expressed optimism regarding the drug's commercial potential pending regulatory approval.
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