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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.

Rhea-AI Summary
TG Therapeutics, Inc. (NASDAQ: TGTX) reported second quarter 2023 financial results, with net sales of $16 million in the United States and total net revenue of approximately $24 million since the launch of BRIUMVI. Over 1,200 BRIUMVI prescriptions have been made by 340+ healthcare providers at 225+ centers across the U.S. Payor coverage is in place for about 80% of covered lives. The company also announced an agreement with Neuraxpharm for the ex-U.S. commercialization of BRIUMVI in RMS, strengthening its balance sheet with a pro-forma cash balance of approximately $285 million.
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TG Therapeutics and Neuraxpharm announce an agreement for the ex-US commercialization of BRIUMVI, the first and only anti-CD20 monoclonal antibody approved for adult patients with relapsing forms of multiple sclerosis. Neuraxpharm will launch BRIUMVI in Europe within the next six months, and TG retains the option to buy back all rights under the agreement if TG is acquired. TG Therapeutics will receive an upfront payment of $140 million and is eligible for up to $492.5 million in milestone-based payments. TG will also receive tiered double-digit royalties on net product sales up to 30%.
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TG Therapeutics, Inc. (NASDAQ: TGTX) will hold a conference call on August 1, 2023, at 8:30 AM ET to discuss second quarter 2023 results and provide a business outlook. Chairman and CEO, Michael S. Weiss, will host the call. Participants can join by calling 1-877-407-8029 (U.S.) or 1-201-689-8029 (outside the U.S.) with the conference title 'TG Therapeutics.' A live webcast will be available on the company's website, and an audio recording will be accessible for 30 days after the call.
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TG Therapeutics CEO to participate in fireside chat at Jefferies Healthcare Conference
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TG Therapeutics announces Q1 2023 financial results, with net sales of $7.8 million for BRIUMVI, the anti-CD20 monoclonal antibody for multiple sclerosis. Over 400 prescriptions received in the first partial quarter. Payor coverage in place for over 50% of covered lives. Conference call to discuss results and business outlook scheduled for May 1, 2023.
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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.

TG Therapeutics, Inc.

Nasdaq:TGTX

TGTX Rankings

TGTX Stock Data

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