BRIUMVI Shows Significant Efficacy in Highly Active Relapsing Multiple Sclerosis
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 8 hours ago
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Should l Buy TGTX?
Source: Newsfilter
- Clinical Trial Results: In the ULTIMATE I and II Phase 3 trials, BRIUMVI demonstrated significant efficacy in 168 patients with highly active relapsing multiple sclerosis, achieving an annualized relapse rate of 0.145 at 96 weeks compared to 0.496 for teriflunomide, representing a 70.8% reduction (P<0.001), indicating its critical potential in controlling disease progression.
- Reduction in MRI Activity: At Week 12, BRIUMVI reduced the least squares mean number of Gd+ T1 lesions by 83.3% (0.114 vs 0.683; P<0.001), and over 96 weeks, Gd+ T1 lesions decreased by 95.6% (0.038 vs 0.875; P<0.001), demonstrating effective control of disease activity radiologically.
- Increased NEDA-3 Rates: BRIUMVI achieved a NEDA-3 rate of 29.5% at Week 12 compared to 10.1% for teriflunomide (OR [95% CI], 4.716 [1.847–12.046]; P=0.001), with rates rising to 77.9% versus 16.4% during Weeks 24-96, underscoring the importance of early treatment.
- Therapeutic Regimen Advantage: BRIUMVI's administration involves a 150mg IV infusion followed by 450mg two weeks later and every 24 weeks, showcasing its feasibility and advantages in effectively treating patients with relapsing multiple sclerosis, supporting early intervention to mitigate disease progression risks.
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Analyst Views on TGTX
Wall Street analysts forecast TGTX stock price to rise
4 Analyst Rating
3 Buy
0 Hold
1 Sell
Moderate Buy
Current: 29.270
Low
15.00
Averages
43.50
High
60.00
Current: 29.270
Low
15.00
Averages
43.50
High
60.00
About TGTX
TG Therapeutics, Inc. is a fully integrated, commercial stage, biopharmaceutical company. The Company is focused on the acquisition, development, and commercialization of novel treatments for B-cell diseases. Its clinical drug candidates are Ublituximab IV (anti-CD20 mAb), Ublituximab Subcutaneous (anti-CD20 mAb), Azer-cel, TG-1701 (BTK inhibitor), and TG-1801 (anti-CD47/CD19 bispecific mAb). BRIUMVI is an anti-CD20 monoclonal antibody for the treatment of RMS, which includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. TG-1701 is a novel, orally available and covalently bound Bruton’s tyrosine kinase (BTK) inhibitor that exhibits selectivity to BTK in vitro kinase screening. TG-1801 is a bispecific CD47 and CD19 antibody. It also evaluates complementary products, technologies and companies for in-licensing, partnership, acquisition, and/or investment opportunities.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
BRIUMVI Shows Significant Efficacy in Highly Active Relapsing Multiple Sclerosis
- Clinical Trial Results: In the ULTIMATE I and II Phase 3 trials, BRIUMVI demonstrated significant efficacy in 168 patients with highly active relapsing multiple sclerosis, achieving an annualized relapse rate of 0.145 at 96 weeks compared to 0.496 for teriflunomide, representing a 70.8% reduction (P<0.001), indicating its critical potential in controlling disease progression.
- Reduction in MRI Activity: At Week 12, BRIUMVI reduced the least squares mean number of Gd+ T1 lesions by 83.3% (0.114 vs 0.683; P<0.001), and over 96 weeks, Gd+ T1 lesions decreased by 95.6% (0.038 vs 0.875; P<0.001), demonstrating effective control of disease activity radiologically.
- Increased NEDA-3 Rates: BRIUMVI achieved a NEDA-3 rate of 29.5% at Week 12 compared to 10.1% for teriflunomide (OR [95% CI], 4.716 [1.847–12.046]; P=0.001), with rates rising to 77.9% versus 16.4% during Weeks 24-96, underscoring the importance of early treatment.
- Therapeutic Regimen Advantage: BRIUMVI's administration involves a 150mg IV infusion followed by 450mg two weeks later and every 24 weeks, showcasing its feasibility and advantages in effectively treating patients with relapsing multiple sclerosis, supporting early intervention to mitigate disease progression risks.
See More
TG Therapeutics Announces BRIUMVI® Presentation Schedule at AAN 2026
- Presentation Schedule: TG Therapeutics will showcase BRIUMVI® (ublituximab-xiiy) data for patients with relapsing forms of multiple sclerosis at the 2026 American Academy of Neurology annual meeting, scheduled for April 21, 2026, which is expected to attract industry attention and enhance the company's visibility in this field.
- Research Findings: The presentation will highlight real-world clinical experiences from the ENABLE study, focusing on the effects of BRIUMVI in patients with relapsing multiple sclerosis, which is anticipated to provide crucial data support for clinical practice and further drive market acceptance of BRIUMVI.
- Safety Updates: The ENHANCE study will offer updates on the safety and tolerability of a modified dosing regimen for BRIUMVI, which is expected to bolster physician confidence in the drug, thereby promoting its clinical application.
- Market Potential: As a monoclonal antibody targeting CD20, BRIUMVI has received approvals in the U.S. and several other countries, expected to address the treatment needs of over 2.3 million multiple sclerosis patients worldwide, further solidifying TG Therapeutics' market position in the biopharmaceutical sector.
See More
TG Therapeutics Reports Strong Q4 2025 Earnings and Growth Outlook
- Significant Revenue Growth: TG Therapeutics reported approximately $616 million in total global revenue for 2025, with $594 million from U.S. BRIUMVI net sales, and a strong fourth quarter revenue of $183 million, reflecting a 92% year-over-year growth and 20% sequential growth, indicating robust market demand and product acceptance.
- Clinical Data Support: Six-year open-label extension data for BRIUMVI shows nearly 90% of patients free from 24-week confirmed disability progression, enhancing physician and patient confidence and laying a solid foundation for future market promotion.
- Share Buyback Program: The company completed a $100 million share repurchase program and received board approval for an additional $100 million buyback, with management viewing current share prices as significantly undervalued and planning to leverage to reduce share count, thereby enhancing shareholder value.
- Optimistic Outlook: TG Therapeutics reaffirmed its 2026 U.S. BRIUMVI net revenue guidance of $825 million to $850 million and total global revenue of $875 million to $900 million, with first-quarter revenue expected to grow sequentially to approximately $185 million to $190 million, showcasing ongoing market expansion potential.
See More
TG Therapeutics Q4 Earnings Miss Expectations with Revenue Growth
- Earnings Performance: TG Therapeutics reported a Q4 GAAP EPS of $0.14, missing expectations by $0.21, indicating pressure on profitability that could affect investor confidence.
- Significant Revenue Growth: Despite a 78% year-over-year revenue increase to $192.6 million, the figure fell short of market expectations by $0.74 million, reflecting cautious sentiment regarding the company's future growth.
- 2026 Financial Guidance: The company projects total global revenue for 2026 to be approximately $875-$900 million, including an estimated $825-$850 million in U.S. net product revenue from BRIUMVI, demonstrating strong confidence in new product performance.
- Cost Control Measures: TG Therapeutics anticipates operating expenses for 2026 to be around $350 million, excluding non-cash compensation, plus $100 million in manufacturing costs, indicating a focus on managing costs while expanding production capacity.
See More
TG Therapeutics Set to Announce Q4 Earnings on February 26
- Earnings Announcement: TG Therapeutics (TGTX) is scheduled to release its Q4 earnings report on February 26 before the market opens, with significant anticipation from the market regarding its performance.
- Earnings Expectations: The consensus EPS estimate stands at $0.33, indicating an improvement in the company's profitability compared to the previous year.
- Revenue Projections: Revenue is expected to reach $193.34 million, reflecting a robust year-over-year growth of 78.7%, showcasing the company's strong growth momentum in the market.
- Estimate Revisions: Over the last three months, EPS estimates have seen three upward revisions and one downward revision, while revenue estimates have experienced seven upward revisions with no downward adjustments, indicating increased market confidence in TG Therapeutics' future performance.
See More
TG Therapeutics to Host Q4 2025 Earnings Call
- Earnings Call Scheduled: TG Therapeutics will hold a conference call on February 26, 2026, at 8:30 AM ET to discuss Q4 and full-year 2025 results, along with a business outlook for 2026, which is expected to positively influence investor confidence.
- Executive Hosting: The call will be hosted by CEO and Chairman Michael S. Weiss, aiming to enhance investor understanding and trust in the company's future developments through direct communication.
- Financial Results Announcement: TG Therapeutics will issue a press release with financial results prior to the call, providing key financial data that will help investors assess the company's market performance and growth potential in the biotechnology sector.
- Live Webcast and Replay: The call will be available via live webcast on the company's website and will offer a 30-day audio replay, ensuring that investors who cannot participate live can still access important information, thereby enhancing transparency.
See More
BRIUMVI Shows Significant Efficacy in Highly Active Relapsing Multiple Sclerosis
- Clinical Trial Results: In the ULTIMATE I and II Phase 3 trials, BRIUMVI demonstrated significant efficacy in 168 patients with highly active relapsing multiple sclerosis, achieving an annualized relapse rate of 0.145 at 96 weeks compared to 0.496 for teriflunomide, representing a 70.8% reduction (P<0.001), indicating its critical potential in controlling disease progression.
- Reduction in MRI Activity: At Week 12, BRIUMVI reduced the least squares mean number of Gd+ T1 lesions by 83.3% (0.114 vs 0.683; P<0.001), and over 96 weeks, Gd+ T1 lesions decreased by 95.6% (0.038 vs 0.875; P<0.001), demonstrating effective control of disease activity radiologically.
- Increased NEDA-3 Rates: BRIUMVI achieved a NEDA-3 rate of 29.5% at Week 12 compared to 10.1% for teriflunomide (OR [95% CI], 4.716 [1.847–12.046]; P=0.001), with rates rising to 77.9% versus 16.4% during Weeks 24-96, underscoring the importance of early treatment.
- Therapeutic Regimen Advantage: BRIUMVI's administration involves a 150mg IV infusion followed by 450mg two weeks later and every 24 weeks, showcasing its feasibility and advantages in effectively treating patients with relapsing multiple sclerosis, supporting early intervention to mitigate disease progression risks.
See More
TG Therapeutics Announces BRIUMVI® Presentation Schedule at AAN 2026
- Presentation Schedule: TG Therapeutics will showcase BRIUMVI® (ublituximab-xiiy) data for patients with relapsing forms of multiple sclerosis at the 2026 American Academy of Neurology annual meeting, scheduled for April 21, 2026, which is expected to attract industry attention and enhance the company's visibility in this field.
- Research Findings: The presentation will highlight real-world clinical experiences from the ENABLE study, focusing on the effects of BRIUMVI in patients with relapsing multiple sclerosis, which is anticipated to provide crucial data support for clinical practice and further drive market acceptance of BRIUMVI.
- Safety Updates: The ENHANCE study will offer updates on the safety and tolerability of a modified dosing regimen for BRIUMVI, which is expected to bolster physician confidence in the drug, thereby promoting its clinical application.
- Market Potential: As a monoclonal antibody targeting CD20, BRIUMVI has received approvals in the U.S. and several other countries, expected to address the treatment needs of over 2.3 million multiple sclerosis patients worldwide, further solidifying TG Therapeutics' market position in the biopharmaceutical sector.
See More
TG Therapeutics Reports Strong Q4 2025 Earnings and Growth Outlook
- Significant Revenue Growth: TG Therapeutics reported approximately $616 million in total global revenue for 2025, with $594 million from U.S. BRIUMVI net sales, and a strong fourth quarter revenue of $183 million, reflecting a 92% year-over-year growth and 20% sequential growth, indicating robust market demand and product acceptance.
- Clinical Data Support: Six-year open-label extension data for BRIUMVI shows nearly 90% of patients free from 24-week confirmed disability progression, enhancing physician and patient confidence and laying a solid foundation for future market promotion.
- Share Buyback Program: The company completed a $100 million share repurchase program and received board approval for an additional $100 million buyback, with management viewing current share prices as significantly undervalued and planning to leverage to reduce share count, thereby enhancing shareholder value.
- Optimistic Outlook: TG Therapeutics reaffirmed its 2026 U.S. BRIUMVI net revenue guidance of $825 million to $850 million and total global revenue of $875 million to $900 million, with first-quarter revenue expected to grow sequentially to approximately $185 million to $190 million, showcasing ongoing market expansion potential.
See More
TG Therapeutics Q4 Earnings Miss Expectations with Revenue Growth
- Earnings Performance: TG Therapeutics reported a Q4 GAAP EPS of $0.14, missing expectations by $0.21, indicating pressure on profitability that could affect investor confidence.
- Significant Revenue Growth: Despite a 78% year-over-year revenue increase to $192.6 million, the figure fell short of market expectations by $0.74 million, reflecting cautious sentiment regarding the company's future growth.
- 2026 Financial Guidance: The company projects total global revenue for 2026 to be approximately $875-$900 million, including an estimated $825-$850 million in U.S. net product revenue from BRIUMVI, demonstrating strong confidence in new product performance.
- Cost Control Measures: TG Therapeutics anticipates operating expenses for 2026 to be around $350 million, excluding non-cash compensation, plus $100 million in manufacturing costs, indicating a focus on managing costs while expanding production capacity.
See More
TG Therapeutics Set to Announce Q4 Earnings on February 26
- Earnings Announcement: TG Therapeutics (TGTX) is scheduled to release its Q4 earnings report on February 26 before the market opens, with significant anticipation from the market regarding its performance.
- Earnings Expectations: The consensus EPS estimate stands at $0.33, indicating an improvement in the company's profitability compared to the previous year.
- Revenue Projections: Revenue is expected to reach $193.34 million, reflecting a robust year-over-year growth of 78.7%, showcasing the company's strong growth momentum in the market.
- Estimate Revisions: Over the last three months, EPS estimates have seen three upward revisions and one downward revision, while revenue estimates have experienced seven upward revisions with no downward adjustments, indicating increased market confidence in TG Therapeutics' future performance.
See More
TG Therapeutics to Host Q4 2025 Earnings Call
- Earnings Call Scheduled: TG Therapeutics will hold a conference call on February 26, 2026, at 8:30 AM ET to discuss Q4 and full-year 2025 results, along with a business outlook for 2026, which is expected to positively influence investor confidence.
- Executive Hosting: The call will be hosted by CEO and Chairman Michael S. Weiss, aiming to enhance investor understanding and trust in the company's future developments through direct communication.
- Financial Results Announcement: TG Therapeutics will issue a press release with financial results prior to the call, providing key financial data that will help investors assess the company's market performance and growth potential in the biotechnology sector.
- Live Webcast and Replay: The call will be available via live webcast on the company's website and will offer a 30-day audio replay, ensuring that investors who cannot participate live can still access important information, thereby enhancing transparency.
See More
