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Tag: TG Therapeutics Inc

  • TG Therapeutics (TGTX) Sees Significant Stock Surge After Financial Update

    TG Therapeutics (TGTX) Sees Significant Stock Surge After Financial Update

    The most recent business update and financial results announcement from TG Therapeutics, Inc. (NASDAQ: TGTX) is driving the share price higher on the charts. As of the most recent check today, TGTX stock was trading at $34.79, with a 15.62% rise.

    Strong Revenue Growth

    TG Therapeutics reported net product revenue of approximately $313.7 million for the full year, ending on December 31, 2024, and $107.3 million for the fourth quarter. Sales of BRIUMVI in the US were the primary driver of this revenue, which was $103.6 million in the fourth quarter and $310.0 million for the whole year—a remarkable 250% year-over-year rise.

    Growth and Enhanced Patent Portfolio

    The high level of acceptability of BRIUMVI among adult patients with relapsing forms of multiple sclerosis has been credited with TG Therapeutics’ remarkable performance over the past 12 months. By launching BRIUMVI in a number of EU and UK nations, TG Therapeutics expanded its worldwide market reach in partnership with Neuraxpharm. The company’s strategy goal to improve accessibility and spur further growth is in line with the expansion.

    Research and Clinical Developments

    Clinical research has advanced significantly thanks to TG Therapeutics, especially with the continued development of BRIUMVI. The release of five-year results from the open-label extension study of the ULTIMATE I & II Phase 3 trials marked a significant turning point. With an annualized relapse rate of 0.02 in year five, the results showed that 92% of patients were still free from disability progression after five years of therapy.

    Additionally, the study verified that no new unfavorable signals appeared with extended therapy, and the safety profile was stable. The business also recruited patients with Myasthenia Gravis in another Phase 1 research and started a Phase 1 trial assessing subcutaneous ublituximab for relapse multiple sclerosis.

    Strategic Collaboration and Prospects

    In an attempt to broaden its therapeutic offerings, TG Therapeutics and Precision BioSciences, Inc. inked a global licensing agreement for the development and marketing of Precision’s allogeneic CD19 CAR T therapy product, azercabtagene zapreleucel (azer-cel). With a strong pipeline, important partnerships, and strong financial results, TG Therapeutics is well-positioned for continued success as it works toward developing innovative treatments for autoimmune diseases.

  • TG Therapeutics (NASDAQ: TGTX) Ublituximab Receives Fast Track Designation In US

    TG Therapeutics (NASDAQ: TGTX) Ublituximab Receives Fast Track Designation In US

    TG Therapeutics, Inc. (NASDAQ: TGTX) has announced Wednesday that it has received the Fast Track Designation for its ublituximab/umbralisib combo for the treatment of adult patients with chronic lymphocytic leukemia (CLL) from the FDA.

    Fast Track is basically the program developed to speed up the review of drugs that treat serious diseases and address unmet medical needs. Filling an unmet medical need is to provide the treatment for those diseases for which no medical treatment is available earlier or offering a medical treatment that may be better than available therapy.

    TG Therapeutics, Inc. (NASDAQ: TGTX) shares were trading up 0.31% at $28.75 at the time of writing on Wednesday. TG Therapeutics, Inc. share price went from a low point around $5.38 to briefly over $31.97 in the past 52 weeks, though shares have since pulled back to $28.75. TGTX market cap has remained high, hitting $334.37M at the time of writing.

    The application of Fast Track designation is based on the data from UNITY-CLL Phase 3 study. The company has announced earlier in UNITY-CLL Phase 3 data that the treatment has shown a positive result. This Fast Track Designation is very important for the company. UNITY-CLL Phase 3 is the study to analyze the combination of ublituximab and umbralisib. Ublituximab is a glycoengineered anti-CD20 monoclonal antibody, and umbralisib is a dual inhibitor of PI3K-delta and CK1-epsilon.

    Chronic lymphocytic leukemia (CLL) is a serious issue in the current period as more than 20,000 new cases have been reported alone in the US. After initial treatment, its symptoms disappear for a period of time but the disease is considered incurable. People need additional treatment after the return of the malignant cells.