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, Inc. (NASDAQ: TGTX) presented four data presentations during the 63rd American Society of Hematology (ASH) annual meeting, focusing on the investigational therapies U2 (ublituximab and umbralisib) and TG-1701. Key results include a 70% overall response rate in relapsed/refractory marginal zone lymphoma patients and significant findings in chronic lymphocytic leukemia therapy. The company aims to enhance patient care for B-cell malignancies through ongoing research. The results highlight the potential of U2-based therapies for improving treatment outcomes.
TG Therapeutics, Inc. (NASDAQ: TGTX) announced the schedule for data presentations at the 63rd American Society of Hematology (ASH) annual meeting from December 11-14, 2021. Key oral presentations include the efficacy of U2 (Umbralisib and Ublituximab) in treating various hematologic malignancies. Presentations focus on relapsed/refractory marginal zone lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. The company continues to advance its pipeline, including the accelerated FDA approval of UKONIQ® for specific lymphoma treatments.
TG Therapeutics announced that the FDA plans to hold an Oncologic Drugs Advisory Committee (ODAC) meeting regarding the BLA/sNDA for the combination of ublituximab and UKONIQ® (U2) for treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The ODAC meeting aims to evaluate the benefit-risk profile of U2, especially in light of recent survival data from the UNITY-CLL trial. The FDA may not reach a decision by the PDUFA date of March 25, 2022, due to the anticipated timing of the ODAC meeting in March or April 2022.
TG Therapeutics (NASDAQ: TGTX) announced that its Executive Chairman and CEO, Michael S. Weiss, will host a fireside chat during the Jefferies London Healthcare Conference on November 18-19, 2021. The chat will be available for on-demand download starting at 8:00 AM GMT / 3:00 AM ET on November 18. Investors can access the discussion on the company's website for 30 days post-event. The company focuses on treatments for B-cell malignancies and autoimmune diseases, with ongoing Phase 3 programs for multiple sclerosis and chronic lymphocytic leukemia.
TG Therapeutics, Inc. (NASDAQ: TGTX) announced a fireside chat with CEO Michael S. Weiss scheduled for November 11, 2021, at 12:00 PM ET, during the B. Riley Securities’ Fall 2021 Growth Biotech Best Ideas Virtual Series. The event will be accessible via a live webcast on the company's website, with a replay available post-event. TG Therapeutics focuses on innovative treatments for B-cell malignancies and autoimmune diseases, including UKONIQ®, which has received accelerated FDA approval.
TG Therapeutics announced six abstracts for the 63rd ASH annual meeting, scheduled for December 11-14, 2021, in Atlanta, Georgia. Key presentations will include new data from the UNITY-NHL Phase 2b trial and two analyses from the UNITY-CLL Phase 3 trial, focusing on patients with comorbidities. The company emphasizes the potential of its U2 combination therapy for B-cell malignancies. Oral and poster presentations are detailed, showcasing the innovations in treating chronic lymphocytic leukemia and B-cell malignancies. More information is available on ASH's website.
TG Therapeutics, Inc. (TGTX) announced its third-quarter financial results for 2021, highlighting the submission of a Biologics License Application (BLA) for ublituximab to treat relapsing multiple sclerosis. The company reported product revenues of $4.3 million since UKONIQ's launch. R&D expenses rose to $52 million, driven by BLA submission costs, while SG&A expenses increased to $34.9 million. Despite a net loss of $85.6 million, TG Therapeutics maintains a robust cash position of $381.4 million, projected to fund operations into 2023. A conference call will be held today to discuss these results.
TG Therapeutics (NASDAQ: TGTX) will hold a conference call on November 4, 2021, at 8:30 AM ET to discuss Q3 2021 results and provide a business outlook for the remainder of the year. The call will be hosted by Michael S. Weiss, Chairman and CEO. Participants can join by calling the provided numbers, with a live webcast available on the company's website. A financial results press release will precede the call.
TG Therapeutics, Inc. (TGTX) announced significant data from the Phase 3 ULTIMATE I & II trials at ECTRIMS 2021, showing that ublituximab treatment resulted in a statistically significant reduction in annualized relapse rate (ARR) compared to teriflunomide. Key findings include an ARR of 0.076 vs. 0.188 in ULTIMATE I and 0.091 vs. 0.178 in ULTIMATE II, representing reductions of approximately 60% and 50%, respectively. Ublituximab also demonstrated notable improvements in the Multiple Sclerosis Functional Composite (MSFC) score, with data supporting a Biologics License Application (BLA) to the FDA for treating relapsing forms of multiple sclerosis.
TG Therapeutics, Inc. (NASDAQ: TGTX) has submitted a Biologics License Application (BLA) to the FDA for its investigational drug, ublituximab, to treat relapsing forms of multiple sclerosis (RMS). This submission is based on the successful Phase 3 ULTIMATE I & II trials, which showed ublituximab significantly reduced the annualized relapse rate compared to teriflunomide. The trials enrolled 1,094 patients across 10 countries and were conducted under a Special Protocol Assessment with the FDA. This marks TG Therapeutics' first marketing application for an autoimmune indication.
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