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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.

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TG Therapeutics (NASDAQ: TGTX) has scheduled a conference call for May 10, 2021, at 8:30 AM ET to discuss its Q1 2021 financial results and provide a business outlook. The call will be led by Executive Chairman and CEO Michael S. Weiss. Participants can join the call by dialing the designated numbers or via a live webcast on the company's website. TG Therapeutics is focused on novel treatments for B-cell malignancies and autoimmune diseases, with several investigational medicines currently in development, including UKONIQ™, which has received accelerated FDA approval.

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TG Therapeutics (NASDAQ: TGTX) announced that CEO Michael S. Weiss will participate in a fireside chat at the B. Riley Securities Neuroscience Conference on April 28, 2021, at 9:00 AM ET. The event will be held virtually, and a live webcast will be available on the company’s website. TG Therapeutics focuses on developing treatments for B-cell malignancies and autoimmune diseases, with an active research pipeline and FDA-approved UKONIQ™ for specific lymphoma treatments.

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Samsung Biologics and TG Therapeutics have expanded their contract manufacturing partnership for ublituximab, an investigational anti-CD20 monoclonal antibody. TG Therapeutics has submitted a Biologics License Application (BLA) to the FDA for ublituximab combined with UKONIQ for chronic lymphocytic leukemia (CLL) treatment, following positive Phase 3 trial results. Samsung is also building its largest biomanufacturing facility, set to boost global capacity. Ublituximab results from advanced glycoengineering aimed at enhancing treatment efficacy against B-cell malignancies.

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TG Therapeutics (TGTX) has completed patient enrollment in the ULTRA-V Phase 2 trial and is initiating the ULTRA-V Phase 3 trial for patients with chronic lymphocytic leukemia (CLL). The Phase 3 trial will evaluate a triple combination therapy of UKONIQ™, ublituximab, and venetoclax. The primary endpoint is Progression-free Survival (PFS). Approximately 165 patients have been enrolled in the Phase 2 trial. The company looks forward to presenting Phase 2 results at future medical meetings, with further development and regulatory plans hinging on these outcomes.

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TG Therapeutics announced positive results from its Phase 3 trials, ULTIMATE I & II, for ublituximab versus teriflunomide in relapsing multiple sclerosis (RMS). Ublituximab showed a statistically significant reduction in annualized relapse rates, achieving a 60% reduction in ULTIMATE I (ARR: 0.076 vs. 0.188) and 50% reduction in ULTIMATE II (ARR: 0.091 vs. 0.178). MRI results revealed a 97% reduction in enhancing lesions. Ublituximab was well tolerated, with plans for a BLA submission in Q3 2021.

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TG Therapeutics (NASDAQ: TGTX) has scheduled a webcast for April 16, 2021, at 8:30 AM ET for the American Academy of Neurology (AAN) Annual Meeting. The event will discuss the ULTIMATE I & II Phase 3 trials of ublituximab for treating relapsing multiple sclerosis (RMS). Results indicate a statistically significant reduction in annualized relapse rates, supporting a Biologics License Application (BLA) submission targeted for mid-2021. The ULTIMATE trials enrolled 1,094 patients across 10 countries and met primary endpoints with promising efficacy results.

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TG Therapeutics, Inc. (NASDAQ: TGTX) has completed the rolling submission of a Biologics License Application (BLA) to the FDA for ublituximab and UKONIQ (umbralisib) as a treatment for chronic lymphocytic leukemia (CLL). This submission follows the results of the UNITY-CLL Phase 3 trial, which met its primary endpoint of superior progression-free survival. The FDA has granted Fast Track and orphan drug designations for this combination therapy. TG Therapeutics aims to expedite the approval process and bring this therapy to patients with CLL as quickly as possible.

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TG Therapeutics, Inc. (NASDAQ: TGTX) announced the publication of results from the UNITY-NHL Phase 2b trial in the Journal of Clinical Oncology, evaluating UKONIQ™ (umbralisib) for relapsed or refractory indolent non-Hodgkin Lymphoma (iNHL). The trial showed an overall response rate (ORR) of 47.1% among 208 patients. For marginal zone lymphoma, ORR was 49.3%, while follicular lymphoma had an ORR of 45.3%. The safety profile was manageable, with notable adverse events including neutropenia (11.5%) and diarrhea (10.1%). UKONIQ is now FDA-approved for specific lymphoma treatments.

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TG Therapeutics announced that the results of the Phase 3 trials, ULTIMATE I & II, evaluating ublituximab for relapsing forms of multiple sclerosis (RMS), will be presented at the American Academy of Neurology meeting from April 17-22, 2021. The trials included 1,094 patients and showed a statistically significant reduction in annualized relapse rate (ARR) over 96 weeks, achieving an ARR of less than 0.10. The company plans to submit a Biologics License Application (BLA) for ublituximab by mid-2021.

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TG Therapeutics (NASDAQ: TGTX) announced that Michael S. Weiss, Executive Chairman and CEO, will present at the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. The presentation will be available for on-demand download starting March 9 at 7:00 AM ET. A replay can be accessed on the Company’s Events page in the Investors & Media section of its website.

TG Therapeutics focuses on innovative therapies for B-cell malignancies and autoimmune diseases, with multiple investigational medicines and FDA-approved treatments like UKONIQ™ for specific lymphoma types.

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FAQ

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

The current stock price of TG Therapeutics (TGTX) is $32.16 as of December 24, 2024.

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

The market cap of TG Therapeutics (TGTX) is approximately 5.0B.

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.

TG Therapeutics, Inc.

Nasdaq:TGTX

TGTX Rankings

TGTX Stock Data

5.01B
140.87M
9.5%
66.38%
18.2%
Biotechnology
Pharmaceutical Preparations
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