NEW YORK, Nov. 19, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced it ranked number 27 on the Deloitte Technology Fast 500™, a ranking of the 500 fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies in North America, now in its 31st year. The Company’s growth between fiscal years 2021 to 2024 was fueled by BRIUMVI® revenues, which was approved in the United States by the Food and Drug Administration (FDA) to treat adult indiv ...

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I publish my best ideas and top coverage on the Growth Stock Forum . If you're interested in finding great growth stocks, with a focus on biotech, consider signing up. We focus on attractive risk/reward situations and track each of our portfolio and watchlist stocks closely. To receive e-mail notifications for my public articles and blogs, please click the follow button . And to go deeper, sign up to Growth Stock Forum.There was not much TG Therapeutics ( TGTX ) has done so far this year that I can criticiz ...

When I last wrote about TG Therapeutics ( TGTX ) in August, I noted a couple of softer quarters of Briumvi sales growth. I rated TGTX a hold at that time, as there was room for a TV campaign to aid sales nearer-term, withScientist and trader of biotech stock. Focus on trading around events such as trial results and NDA/BLA approvals. Also covering companies in industries regulated by the FDA. Articles present my opinion on stocks, but don't constitute investment advice.Analyst’s Disclosure:I/we have a benef ...

Group 1 - The core viewpoint indicates that TG Therapeutics (TGTX) experienced softer sales growth for Briumvi in recent quarters, leading to a hold rating due to potential for a TV campaign to boost near-term sales [1] Group 2 - The article emphasizes the importance of trading around significant events such as trial results and NDA/BLA approvals in the biotech sector [1]

TG Therapeutics Conference Call Summary Company Overview - **Company**: TG Therapeutics (NasdaqCM:TGTX) - **Event**: Conference Call on November 12, 2025 Key Points Product Performance and Market Position - **Briumvi Launch Success**: Briumvi has established itself as a trusted product among physicians, with many moving it to the first IV slot due to its data and patient convenience [3][5] - **Patient Support Programs**: TG Therapeutics maintains the most generous patient support programs, unlike competitors who have cut back, contributing to its market position [5][6] - **Crossover Patients**: A significant portion of Briumvi's patients are switching from other therapies, with a stable distribution among naive patients, switches from non-CD20 therapies, and switches from other CD20 therapies [9][10] Clinical Trials and Future Expectations - **Enhanced Trial Enrollment**: Impressive enrollment rates in the enhanced trial combining initial doses, with expectations for a successful outcome based on area under the curve measures [12][13] - **Subcutaneous (SubQ) Version**: The company is optimistic about the SubQ version of Briumvi, targeting non-inferiority to IV dosing, with enrollment expected to complete in the first half of next year and data anticipated in late 2026 or early 2027 [29][32] Competitive Landscape - **Ocrevus and BTK Inhibitors**: Current market dynamics show limited impact from Ocrevus SubQ on Briumvi's uptake. The company believes BTK inhibitors will compete more in the oral category rather than against CD20 therapies [17][19][20] - **Market Dynamics for SubQ**: The SubQ version is expected to capture a significant market share, potentially doubling the total addressable market, with a competitive edge in convenience over existing products [33][34] Revenue and Growth Expectations - **Q4 Guidance**: The company is confident in meeting or exceeding Q4 guidance, citing positive dynamics typically seen in the fourth quarter [23][24] - **2026 Growth Initiatives**: Plans to expand direct-to-consumer (DTC) campaigns and enhance field team effectiveness to drive growth in 2026 [26][27] Pipeline and Future Projects - **Exploratory Programs**: The company is cautiously optimistic about ongoing exploratory programs, including MG trials and azer-cel, with potential for clearer direction in 2026 [35][36] Additional Insights - **Patient Awareness**: The DTC campaign has reportedly raised awareness, with patients actively requesting Briumvi after seeing commercials, indicating a positive trend for future sales [26][27] - **Team Performance**: The field team has received positive feedback, and the company is considering adding more personnel to strengthen market presence [27][28] This summary encapsulates the key insights from the TG Therapeutics conference call, highlighting the company's strategic positioning, product performance, competitive landscape, and future growth initiatives.

Company Announcement - TG Therapeutics, Inc. will participate in the TD Cowen Immunology & Inflammation Summit virtually from November 12 – 13, 2025, with a fireside chat scheduled for November 12, 2025, at 10:00 AM ET [1] - A live webcast of the fireside chat will be available on the Company's website [2] Company Overview - TG Therapeutics is a fully integrated, commercial stage biopharmaceutical company focused on the acquisition, development, and commercialization of novel treatments for B-cell diseases [3] - The company has received FDA approval for BRIUMVI (ublituximab-xiiy) for treating adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease [3] - BRIUMVI has also received approval from several regulatory agencies outside the U.S. for treating adult patients with relapsing multiple sclerosis who have active disease defined by clinical or imaging features [3]

Core Insights - Roche's fenebrutinib demonstrated "unprecedented" test results for multiple sclerosis, impacting TG Therapeutics negatively [1][2] - Roche's stock increased by over 3% to $43.33, while TG Therapeutics' stock fell more than 5% to $30.53, reaching a two-month low [2] - Fenebrutinib showed significantly fewer relapses compared to teriflunomide in relapsing multiple sclerosis patients [3] - In primary progressive MS, fenebrutinib slowed disability progression comparably to Roche's Ocrevus, the only approved treatment for this condition [4] Roche's Competitive Position - Roche's fenebrutinib uses a different mechanism than TG Therapeutics' Briumvi, targeting BTK, which is involved in immune response to inflammation [7] - Roche's stock performance improved, gapping above its 50-day moving average following the news [7] TG Therapeutics' Market Performance - Briumvi's sales grew by at least double-digit percentages year-over-year, with a notable 84% increase to $152.9 million in Q3 [6] - Despite the sales growth, Briumvi still lags behind Ocrevus in overall sales [6] - TG Therapeutics maintains a strong IBD Digital Composite Rating of 97, ranking in the top 3% of stocks for performance [8]

Financial Performance - The company reported a significant operating loss since inception, indicating potential future losses if current trends continue[13] - The company has incurred significant operating losses, raising concerns about its financial sustainability[13] - The company has incurred substantial operating losses and may need to raise additional capital to fund its drug development programs[17] Regulatory and Market Challenges - The commercialization of BRIUMVI is ongoing, with expectations for market acceptance and pricing still uncertain[12] - Regulatory approvals for BRIUMVI and other product candidates remain a critical focus, with potential delays affecting commercialization[12] - Future regulatory developments could impose additional costs and affect the company's ability to market its products[13] - The company acknowledges that unfavorable pricing regulations and reimbursement policies could adversely affect its business[17] Competition and Market Opportunities - The company has faced substantial competition, which could limit its market opportunities for BRIUMVI and other products[13] - The company faces substantial competition in the pharmaceutical industry, which could limit its commercial opportunities[17] Supply Chain and Development Risks - The company relies on third parties for clinical trials and manufacturing, which poses risks to timely product availability[22] - The company relies on third parties for clinical trials and manufacturing, increasing risks related to product supply and regulatory approval[22] - The company anticipates challenges in maintaining a reliable supply of products to meet market demand, which could impact commercialization efforts[12] Intellectual Property and Personnel - The company is subject to various risks related to intellectual property, including potential challenges to patent validity and enforcement[22] - The company emphasizes the importance of attracting and retaining key personnel for successful product development and commercialization[22] Market Volatility - The company is subject to market volatility, which may impact stock price and investor confidence[21] - The incidence and prevalence of target patient populations for BRIUMVI have not been precisely established, potentially affecting revenue projections[13]

Core Insights - Zacks Premium provides various tools for investors to enhance their stock market strategies, including daily updates, research reports, and stock screens [1] - The Zacks Style Scores are designed to help investors select stocks with the highest potential to outperform the market within a 30-day timeframe [2] Zacks Style Scores Overview - The Style Scores categorize stocks into four main types: Value Score, Growth Score, Momentum Score, and VGM Score, each focusing on different investment strategies [3][4][5][6] - Value Score identifies undervalued stocks using financial ratios [3] - Growth Score assesses a company's future earnings and financial health [4] - Momentum Score capitalizes on existing price trends and earnings outlooks [5] - VGM Score combines all three styles to highlight stocks with the best overall potential [6] Zacks Rank and Performance - The Zacks Rank is a proprietary model that uses earnings estimate revisions to identify stocks, with 1 (Strong Buy) stocks historically yielding an average annual return of +23.93% since 1988, significantly outperforming the S&P 500 [7][8] - Investors are encouraged to focus on stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B for optimal returns [10] Stock Highlight: TG Therapeutics (TGTX) - TG Therapeutics is focused on developing therapies for B-cell diseases and currently holds a Zacks Rank of 3 (Hold) with a VGM Score of B [12] - The company is projected to experience substantial growth, with an expected year-over-year earnings growth of 893.3% for the current fiscal year [12] - Recent analyst revisions have increased the earnings estimate for fiscal 2025, with the Zacks Consensus Estimate rising to $1.49 per share [13] - TGTX has demonstrated a strong average earnings surprise of +217.5%, making it a noteworthy consideration for growth investors [13]