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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
Globenewswire· 2025-02-27 12:30
Core Insights - TG Therapeutics presented data from the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial for BRIUMVI at the ACTRIMS annual forum, highlighting its efficacy and safety in treating relapsing forms of multiple sclerosis (RMS) [1][2] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing treatments for B-cell diseases, with BRIUMVI approved for RMS treatment in the U.S. and Europe [27] Clinical Trial Details - The ULTIMATE I & II trials involved 1,094 patients across 10 countries, comparing BRIUMVI to teriflunomide over 96 weeks, with specific dosing regimens for both treatments [6] - The ENHANCE trial demonstrated a consistent safety profile for BRIUMVI, with over 80 patients receiving a 30-minute maintenance infusion [2][3] Presentation Highlights - An independent study presented by Dr. John Foley showed real-world data from over 160 patients treated with BRIUMVI, confirming its safety and tolerability [2][5] - Additional presentations included studies on disease activity trajectories and the design of a study evaluating Fc biology in multiple sclerosis [4][5] Product Information - BRIUMVI (ublituximab-xiiy) is a monoclonal antibody targeting CD20-expressing B-cells, designed for efficient B-cell depletion at low doses [8] - It is indicated for adults with RMS, including clinically isolated syndrome and active secondary progressive disease [9]
TG Therapeutics to Host Conference Call on Fourth Quarter and Full Year 2024 Financial Results and Business Update
Newsfilter· 2025-02-26 12:30
Core Points - TG Therapeutics, Inc. will hold a conference call on March 3, 2025, at 8:30 AM ET to discuss the fourth quarter and full year 2024 results and provide a business outlook for 2025 [1] - The call will be hosted by Michael S. Weiss, Chairman and CEO of TG Therapeutics [1] - A press release detailing the financial results will be issued prior to the conference call [3] Company Overview - TG Therapeutics is a fully integrated, commercial stage biopharmaceutical company focused on developing and commercializing novel treatments for B-cell diseases [4] - The company has received FDA approval for BRIUMVI® (ublituximab-xiiy) for treating adult patients with relapsing forms of multiple sclerosis [4] - BRIUMVI has also been approved by the European Commission and the Medicines and Healthcare Products Regulatory Agency for similar indications in Europe and the UK [4]
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
Globenewswire· 2025-02-18 12:30
Core Insights - TG Therapeutics, Inc. announced the presentation schedule for data from the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial for BRIUMVI in patients with relapsing forms of multiple sclerosis (RMS) at the ACTRIMS annual forum from February 27 to March 1, 2025 [1][2] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing treatments for B-cell diseases, with BRIUMVI being approved for RMS treatment in the U.S., Europe, and the UK [24] - BRIUMVI is a monoclonal antibody targeting CD20-expressing B-cells, designed to enhance B-cell depletion through glycoengineering [5][6] Clinical Trials - The ULTIMATE I & II trials are randomized, double-blind studies involving 1,094 RMS patients across 10 countries, comparing BRIUMVI to teriflunomide over 96 weeks [3] - The ENHANCE trial focuses on the safety and tolerability of 30-minute BRIUMVI infusions and evaluates Fc biology and genetic diversity in MS [2][3] Presentation Details - Presentations will include topics such as real-world experiences with BRIUMVI and disease activity trajectories in the ULTIMATE trials [2][4] - Specific presentation dates and authors have been outlined for the ACTRIMS forum [4]
All You Need to Know About TG Therapeutics (TGTX) Rating Upgrade to Buy
ZACKS· 2025-01-27 18:00
Core Viewpoint - TG Therapeutics (TGTX) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system emphasizes the importance of changing earnings estimates in determining near-term stock price movements, making it a valuable tool for investors [2][4]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in buying or selling activity that affects stock prices [4]. Company Performance and Outlook - The upgrade for TG Therapeutics indicates a positive outlook for its earnings, suggesting potential buying pressure and an increase in stock price [3][5]. - For the fiscal year ending December 2024, TG Therapeutics is expected to earn $0.09 per share, with a 24.6% increase in the Zacks Consensus Estimate over the past three months [8]. Zacks Rank System - The Zacks Rank system classifies stocks based on earnings estimate revisions, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [7]. - TG Therapeutics' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10].
TG Therapeutics: Entering 2025 With Increased Investor Expectations
Seeking Alpha· 2025-01-23 19:48
Group 1 - TG Therapeutics, Inc. (NASDAQ: TGTX) presented at the JP Morgan Healthcare Conference, where CEO Michael Weiss discussed the company's accomplishments in 2024 and provided updates on its progress [2] - The company is part of the Growth Stock Forum, which features a model portfolio of 15-20 stocks, a top picks list of up to 10 stocks expected to perform well, and trading ideas targeting short-term and medium-term moves [2] Group 2 - The article reflects the author's opinion and does not constitute a buy or sell recommendation or investment advice [3][4]
TG Therapeutics: 2025 Revenues Will Smash Expectations
Seeking Alpha· 2025-01-21 07:17
TG Therapeutics (NASDAQ: TGTX ) is a biotech company focused on Briumvi, a treatment for Multiple Sclerosis. I will not go into great detail on the unique mechanisms of this drug, as this is not myLike millions of other investors, I got Robinhood and started trading during the pandemic. Unlike most of those investors, I carefully studied hundreds of earnings reports for clues to future performance, and I was able to identify many future winners, such as OPRX, OTRK, FUBO, and PLUG. My style of investing is i ...
TGTX Announces 2024 Preliminary Results, 2025 Goals, Shares Rise
ZACKS· 2025-01-15 15:10
TG Therapeutics (TGTX) announced preliminary net product revenues for the fourth quarter and full-year 2024 for its marketed drug, Briumvi (ublituximab-xiiy), which exceeded the company’s initial expectations.TGTX also provided its guidance for 2025 and outlined some expected milestones related to Briumvi label expansion studies and other pipeline candidates for 2025.Briumvi is approved for the treatment of certain adult patients with relapsing forms of multiple sclerosis (RMS).In the past year, shares of T ...
TG Therapeutics (TGTX) Moves 7.5% Higher: Will This Strength Last?
ZACKS· 2025-01-15 14:15
Company Overview - TG Therapeutics (TGTX) shares increased by 7.5% to $29.74, following a significant trading volume, despite a prior 19.6% decline over the last four weeks [1] - The company reported preliminary sales of its drug Briumvi, generating $310 million in 2024, exceeding previous expectations of $300-$305 million [2] - For 2025, management anticipates total revenues of $540 million [2] Earnings Expectations - TGTX is projected to report quarterly earnings of $0.07 per share, reflecting a year-over-year increase of 177.8% [3] - Expected revenues for the upcoming quarter are $96.61 million, representing a 119.7% increase from the same quarter last year [3] - The consensus EPS estimate for TGTX has remained unchanged over the last 30 days, indicating a potential stability in earnings expectations [4] Industry Context - TG Therapeutics operates within the Zacks Medical - Biomedical and Genetics industry, where Puma Biotech (PBYI) also competes [4] - Puma Biotech's consensus EPS estimate has increased by 50% over the past month to $0.14, although this reflects a 54.8% decrease compared to the previous year [5]
TG Therapeutics Provides Preliminary Fourth Quarter and Full Year 2024 Net Revenue and 2025 Anticipated Development Milestones
Globenewswire· 2025-01-14 12:00
Preliminary U.S. BRIUMVI fourth quarter and full year 2024 net product revenue of $103.6 million and $310 million, respectively Full Year 2025 target total global revenue of approximately $540 million, including BRIUMVI U.S. net product revenue of approximately $525 million NEW YORK, Jan. 14, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), yesterday announced preliminary U.S. net product revenue for BRIUMVI® for the fourth quarter and full year ended December 31, 2024 (unaudited), as well as ...
TG Therapeutics: Subcutaneous Briumvi Data A Key Near-Term Catalyst
Seeking Alpha· 2025-01-14 04:38
Company Performance - TG Therapeutics (NASDAQ: TGTX) was rated a buy in March 2024, with the first four quarters of sales of their multiple sclerosis drug, Briumvi, making their 2024 sales guidance seem achievable [1] Industry Focus - The company operates in the biotech industry, with a focus on trading around events such as trial results and NDA/BLA approvals [1] - The industry is regulated by the FDA, which is a key factor in the company's operations and product development [1]