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TG Therapeutics, Inc. - TGTX STOCK NEWS

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)
, targeting B-cell disorders in Phase 1 trials. The company is also working on TG-1101 (ublituximab) and TGR-1202 (umbralisib), both in clinical development for hematologic malignancies.

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.

News

TG Therapeutics Announces Schedule of Data Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the American Academy of Neurology 2024 Annual Meeting

Rhea-AI Summary
TG Therapeutics, Inc. (TGTX) announces data presentations at the American Academy of Neurology 2024 meeting for BRIUMVI® in patients with multiple sclerosis. The presentations focus on the ULTIMATE I & II Phase 3 trials evaluating Ublituximab-xiiy, showcasing significant reductions in disease activity and improved disability outcomes.
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TG Therapeutics Announces Presentation of Data for BRIUMVI® in Multiple Sclerosis at the Americas Committee for Treatment and Research in Multiple Sclerosis Annual Forum

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TG Therapeutics, Inc. (TGTX) presents data from Phase 3 trials on BRIUMVI® for multiple sclerosis at ACTRIMS forum. The trials show promising results with manageable safety profiles. CEO Michael S. Weiss expresses optimism for future trial updates.
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TG Therapeutics Provides Business Update and Reports Fourth Quarter and Year-End 2023 Financial Results

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TG Therapeutics, Inc. reported fourth-quarter and full-year 2023 BRIUMVI U.S. net revenue of approximately $40 million and $89 million, respectively. The company exceeded expectations with the BRIUMVI launch and set a revenue target of $220 - $260 million for 2024. They also announced positive developments in clinical trials, expanded clinical efforts, and partnerships. Financially, the company ended 2023 with a cash position of $217.5 million and reported a net loss of $14.4 million for the fourth quarter and net income of $12.7 million for the full year. TG Therapeutics is optimistic about its pipeline and aims to advance its recent addition, azer-cel, into clinical development for autoimmune disease.
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TG Therapeutics Announces Issuance of Additional Patents for BRIUMVI® (ublituximab-xiiy)

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TG Therapeutics, Inc. announces the issuance of three additional patents by the USPTO for BRIUMVI (ublituximab-xiiy), extending patent protection for ublituximab and treatment methods until 2042. The patents leverage the unique glycoprofile of ublituximab, the first anti-CD20 monoclonal antibody approved for relapsing forms of multiple sclerosis in the US. Michael S. Weiss, Chairman and CEO, highlights the importance of life cycle management and the potential expansion of BRIUMVI's reach in multiple sclerosis and other autoimmune indications.
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TG Therapeutics Announces European Launch of BRIUMVI® (ublituximab-xiiy)

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TG Therapeutics' ex-US partner, Neuraxpharm, launches BRIUMVI in Germany for the treatment of multiple sclerosis, triggering a milestone payment of $12.5 million to TG Therapeutics.
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TG Therapeutics to Host Conference Call on Fourth Quarter and Year-End 2023 Financial Results and Business Update

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TG Therapeutics, Inc. (TGTX) will host a conference call on February 28, 2024, to discuss fourth-quarter and year-end 2023 results and provide a business outlook for 2024. The call will be led by Michael S. Weiss, Chairman, and CEO. Participants can join via phone or webcast. Financial results will be released in a press release before the call.
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TG Therapeutics Announces Schedule of Data Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the Americas Committee for Treatment and Research in Multiple Sclerosis Annual Forum

Rhea-AI Summary
TG Therapeutics, Inc. announces data presentations from Phase 3 trials for BRIUMVI® in patients with relapsing forms of multiple sclerosis at ACTRIMS annual forum.
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Precision BioSciences Receives Initial $7.5 Million Cash Payment and Equity Investment from TG Therapeutics for Azel-Cel in Treatment of Autoimmune Diseases

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Precision BioSciences (DTIL) receives upfront cash payment and equity investment from TG Therapeutics (TGTX) for an exclusive license to develop Azercabtagene Zapreleucel for autoimmune diseases, with potential payments totaling $17.5 million. Precision also expects to receive up to $288 million in milestone payments and royalties on net sales, extending its cash runway into the first half of 2026.
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TG Therapeutics Provides Preliminary Fourth Quarter and Full Year 2023 Net Revenue and 2024 Anticipated Milestones

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TG Therapeutics, Inc. (NASDAQ: TGTX) announced preliminary U.S. net product revenue for BRIUMVI® for the fourth quarter and full year ended December 31, 2023. The company reported approximately $40 million in net product revenue for the fourth quarter and $89 million for the full year. The year-end 2023 cash position was approximately $215 million. TG Therapeutics also provided financial guidance and development milestones for 2024, including targets for net product revenue and operating expenses, as well as plans to expand the utility of BRIUMVI and the R&D program with the licensing of azer-cel, an allogeneic CD19 CAR T therapy.
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TG Therapeutics Announces Global License Agreement with Precision BioSciences for the Development and Commercialization of Precision’s Allogeneic CD19 CAR T Cell Therapy Program for the Treatment of Autoimmune Diseases

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TG Therapeutics, Inc. (TGTX) announces partnership with Precision BioSciences, Inc. (DTIL) to acquire a worldwide license to Precision’s Azercabtagene Zapreleucel (azer-cel) for autoimmune diseases and non-oncology indications. The company plans to evaluate the program in multiple autoimmune indications with an investigational new drug (IND) filing targeted for mid-2024. TG Therapeutics will receive exclusive worldwide rights to develop and commercialize azer-cel in non-oncology indications in exchange for upfront and potential near-term economics valued at $17.5 million.
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FAQ

What is the current stock price of TG Therapeutics (TGTX)?

The current stock price of TG Therapeutics (TGTX) is $34.55 as of November 21, 2024.

What is the market cap of TG Therapeutics (TGTX)?

The market cap of TG Therapeutics (TGTX) is approximately 5.2B.

What is TG Therapeutics' primary focus?

TG Therapeutics focuses on developing and commercializing treatments for B-cell malignancies and autoimmune diseases.

What is BRIUMVI?

BRIUMVI (ublituximab-xiiy) is a monoclonal antibody targeting CD20-expressing B-cells, approved for treating relapsing forms of multiple sclerosis (RMS).

Where is TG Therapeutics headquartered?

The company is headquartered in New York City.

What recent financial performance did TG Therapeutics report?

The company reported over $50 million in BRIUMVI U.S. net revenue for Q1 2024 and updated its annual guidance to $270 to $290 million.

Has BRIUMVI received regulatory approvals outside the U.S.?

Yes, BRIUMVI has been approved by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for RMS treatment in Europe and the UK.

What other therapies is TG Therapeutics developing?

TG Therapeutics is also developing TG-1701, TG-1801, TG-1101 (ublituximab), and TGR-1202 (umbralisib) for B-cell disorders and hematological malignancies.

What are the ULTIMATE I & II Phase 3 trials?

The ULTIMATE I & II trials are clinical studies evaluating the efficacy of BRIUMVI in treating relapsing forms of multiple sclerosis.

What support programs does TG Therapeutics offer for BRIUMVI?

TG Therapeutics offers BRIUMVI Patient Support, a flexible program designed to assist U.S. patients through their treatment journey.

What is the significance of TG Therapeutics' national contract with the VA?

The contract makes BRIUMVI the preferred anti-CD20 antibody therapy for RMS on the VA National Formulary, enhancing access for veterans.

Where can more information about TG Therapeutics be found?

More information is available on the company's website at www.tgtherapeutics.com.

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TG Therapeutics, Inc.

Nasdaq:TGTX

TGTX Rankings

#1277 Ranked by Market Cap
N/A Ranked by Dividends

TGTX Stock Data

5.23B
140.87M
9.5%
66.42%
20.54%
Biotechnology
Pharmaceutical Preparations
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United States of America
NEW YORK