TG Therapeutics ENHANCE Trial Achieves Primary Endpoint
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
0mins
Source: seekingalpha
- Trial Success: TG Therapeutics announced that its Phase 3 ENHANCE trial successfully met the primary endpoint, validating the bioequivalence of a single 600 mg infusion, which demonstrates its potential in treating relapsing forms of multiple sclerosis and may drive future market share growth.
- Safety Assessment: The trial indicated that patients in the single-infusion treatment arm experienced fewer infusion reactions, although the infusion-related reactions between treatment arms were statistically indistinguishable, suggesting a safety advantage that could enhance patient adherence to treatment.
- Future Plans: TG Therapeutics expects to submit a supplemental Biologics License Application in H2 2026, aiming to expand the label to eliminate the need for a Day 15 Briumvi infusion, a strategy that could simplify treatment protocols and enhance market competitiveness.
- Financial Outlook: The company anticipates global revenue of $925 million in 2026, targeting approximately $220 million in Q2 U.S. Briumvi net revenue, reflecting strong market demand and growth potential, further solidifying investor confidence.
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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: 38.820
Low
15.00
Averages
43.50
High
60.00
Current: 38.820
Low
15.00
Averages
43.50
High
60.00
About TGTX
TG Therapeutics, Inc. is a fully integrated, commercial stage biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. Its products include Ublituximab IV (anti-CD20 mAb), Ublituximab IV Simplified Dosing Schedule, Ublituximab Subcutaneous (anti-CD20 mAb), and Azer-cel. It is engaged in late-stage clinical development of BRIUMVI. BRIUMVI is an anti-CD20 monoclonal antibody that can be administered to adults with relapsing forms of multiple sclerosis (RMS) in a one-hour infusion every 24 weeks, following the starting dose. It is used for treatment of adults with clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The Company is also engaged in ULTIMATE I & II Trials Evaluating Single Agent Ublituximab in RMS. Its ENHANCE Phase 3b Trial is an ongoing, multi-center, open-label study designed to evaluate alternative dosing regimens for BRIUMVI in patients with RMS.
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.
TG Therapeutics Reports Positive Phase 3 Results for BRIUMVI in MS Treatment
- Clinical Trial Success: TG Therapeutics reported positive topline results from its Phase 3 ENHANCE study, demonstrating bioequivalent drug exposure between the new single 600 mg infusion and the existing 150 mg and 450 mg regimens, indicating the new approach's efficacy and safety.
- Treatment Regimen Optimization: The implementation of the new regimen will eliminate the need for a second infusion on Day 15, thereby improving patient compliance and treatment convenience, which could enhance BRIUMVI's competitive position in the market.
- FDA Application Plans: The company plans to submit a supplemental Biologics License Application to the U.S. FDA in the second half of 2026, further advancing BRIUMVI's market access and potentially creating new revenue streams for the company.
- Positive Stock Reaction: Following a closing price of $39.73 on Tuesday, TGTX stock gained nearly 2% in pre-market trading, reflecting the market's positive response to the new study results and potentially boosting investor confidence in the company.
See More
TG Therapeutics CEO to Attend Healthcare Conference
- Conference Participation: TG Therapeutics CEO Michael S. Weiss will participate in the Jefferies Global Healthcare Conference on June 3, 2026, in New York, showcasing the company's leadership in biotechnology and attracting investor and industry attention.
- Live Webcast: The fireside chat will be available via a live webcast on the company's website, allowing global investors to access real-time information, thereby enhancing the company's transparency and market trust.
- Product Approval: TG Therapeutics' BRIUMVI® (ublituximab-xiiy) has received FDA approval for treating adult patients with relapsing forms of multiple sclerosis, marking a significant advancement in the biopharmaceutical sector and expected to drive sales growth.
- Market Positioning: With a focus on innovative treatments for B-cell diseases, TG Therapeutics aims to capture a larger share of the rapidly growing biotechnology market through the promotion of BRIUMVI, thereby strengthening its competitive advantage.
See More
TG Therapeutics ENHANCE Trial Achieves Primary Endpoint
- Trial Success: TG Therapeutics announced that its Phase 3 ENHANCE trial successfully met the primary endpoint, validating the bioequivalence of a single 600 mg infusion, which demonstrates its potential in treating relapsing forms of multiple sclerosis and may drive future market share growth.
- Safety Assessment: The trial indicated that patients in the single-infusion treatment arm experienced fewer infusion reactions, although the infusion-related reactions between treatment arms were statistically indistinguishable, suggesting a safety advantage that could enhance patient adherence to treatment.
- Future Plans: TG Therapeutics expects to submit a supplemental Biologics License Application in H2 2026, aiming to expand the label to eliminate the need for a Day 15 Briumvi infusion, a strategy that could simplify treatment protocols and enhance market competitiveness.
- Financial Outlook: The company anticipates global revenue of $925 million in 2026, targeting approximately $220 million in Q2 U.S. Briumvi net revenue, reflecting strong market demand and growth potential, further solidifying investor confidence.
See More
TG Therapeutics Reports Positive Phase 3 ENHANCE Trial Results for BRIUMVI
- Trial Success: The ENHANCE Phase 3 trial successfully met its primary endpoint, demonstrating bioequivalence between a single 600 mg BRIUMVI infusion and the current dual dosing regimen of 150 mg and 450 mg, potentially simplifying treatment processes and improving patient adherence.
- Consistent Safety Profile: The safety and tolerability of the new regimen were consistent with the established safety profile of BRIUMVI, with no new safety signals observed during the trial, enhancing market confidence in the treatment's clinical application.
- Regulatory Filing Plans: TG Therapeutics plans to submit a supplemental Biologics License Application (BLA) in the second half of 2026, and if approved, BRIUMVI would become the first IV anti-CD20 therapy that can be initiated with a single infusion, further solidifying its market position.
- Improved Patient Experience: By eliminating the need for a second infusion, the new regimen simplifies the treatment process, expected to reduce patient scheduling burdens at busy infusion centers, aligning with the company's strategic goal of enhancing patient quality of life.
See More
TG Therapeutics Announces BRIUMVI Data Presentation Schedule at CMSC 2026
- Presentation Schedule: TG Therapeutics will showcase four data presentations on BRIUMVI at the 2026 Consortium of Multiple Sclerosis Centers annual meeting, emphasizing its clinical advantages in relapsing multiple sclerosis (RMS), which is expected to attract industry attention and enhance the company's reputation.
- Clinical Research Findings: New analyses from the ENABLE Phase 4 study indicate significant improvements in patient-reported outcomes, including treatment satisfaction and physical and psychological impact measures, observed as early as Day 15 and sustained through Week 48, highlighting BRIUMVI's long-term benefits for patient experience.
- Real-World Data: The data reveals that 99.4% of patients remained relapse-free after transitioning to BRIUMVI, with a low annualized relapse rate of 0.011, showcasing the drug's exceptional performance in disease control and patient satisfaction, potentially driving market share growth.
- Clinical Trial Background: The ULTIMATE I and II trials enrolled a total of 1,094 patients, demonstrating low rates of infusion-related reactions and consistent infusion times, further solidifying BRIUMVI's competitive edge in RMS treatment.
See More
ACT Capital Management Acquires New Position in Alumis Worth $4.36 Million
- New Position: On May 8, 2026, ACT Capital Management disclosed a new position in Alumis by acquiring 174,250 shares valued at approximately $4.36 million, indicating strong confidence in the company's future prospects.
- Quarterly Valuation: The position's valuation stood at $3.84 million at quarter-end, reflecting the impact of market price changes and share count, highlighting Alumis's significance in the investment portfolio.
- Stock Performance: Alumis shares surged 350% over the past year, significantly outperforming the S&P 500's 30% gain, showcasing its robust growth potential in the biopharmaceutical sector.
- Clinical Progress: Alumis reported positive Phase 3 data for moderate-to-severe plaque psoriasis in March, with plans to submit a New Drug Application in the second half of 2026, further boosting investor confidence in its drug development pipeline.
See More
TG Therapeutics Reports Positive Phase 3 Results for BRIUMVI in MS Treatment
- Clinical Trial Success: TG Therapeutics reported positive topline results from its Phase 3 ENHANCE study, demonstrating bioequivalent drug exposure between the new single 600 mg infusion and the existing 150 mg and 450 mg regimens, indicating the new approach's efficacy and safety.
- Treatment Regimen Optimization: The implementation of the new regimen will eliminate the need for a second infusion on Day 15, thereby improving patient compliance and treatment convenience, which could enhance BRIUMVI's competitive position in the market.
- FDA Application Plans: The company plans to submit a supplemental Biologics License Application to the U.S. FDA in the second half of 2026, further advancing BRIUMVI's market access and potentially creating new revenue streams for the company.
- Positive Stock Reaction: Following a closing price of $39.73 on Tuesday, TGTX stock gained nearly 2% in pre-market trading, reflecting the market's positive response to the new study results and potentially boosting investor confidence in the company.
See More
TG Therapeutics CEO to Attend Healthcare Conference
- Conference Participation: TG Therapeutics CEO Michael S. Weiss will participate in the Jefferies Global Healthcare Conference on June 3, 2026, in New York, showcasing the company's leadership in biotechnology and attracting investor and industry attention.
- Live Webcast: The fireside chat will be available via a live webcast on the company's website, allowing global investors to access real-time information, thereby enhancing the company's transparency and market trust.
- Product Approval: TG Therapeutics' BRIUMVI® (ublituximab-xiiy) has received FDA approval for treating adult patients with relapsing forms of multiple sclerosis, marking a significant advancement in the biopharmaceutical sector and expected to drive sales growth.
- Market Positioning: With a focus on innovative treatments for B-cell diseases, TG Therapeutics aims to capture a larger share of the rapidly growing biotechnology market through the promotion of BRIUMVI, thereby strengthening its competitive advantage.
See More
TG Therapeutics ENHANCE Trial Achieves Primary Endpoint
- Trial Success: TG Therapeutics announced that its Phase 3 ENHANCE trial successfully met the primary endpoint, validating the bioequivalence of a single 600 mg infusion, which demonstrates its potential in treating relapsing forms of multiple sclerosis and may drive future market share growth.
- Safety Assessment: The trial indicated that patients in the single-infusion treatment arm experienced fewer infusion reactions, although the infusion-related reactions between treatment arms were statistically indistinguishable, suggesting a safety advantage that could enhance patient adherence to treatment.
- Future Plans: TG Therapeutics expects to submit a supplemental Biologics License Application in H2 2026, aiming to expand the label to eliminate the need for a Day 15 Briumvi infusion, a strategy that could simplify treatment protocols and enhance market competitiveness.
- Financial Outlook: The company anticipates global revenue of $925 million in 2026, targeting approximately $220 million in Q2 U.S. Briumvi net revenue, reflecting strong market demand and growth potential, further solidifying investor confidence.
See More
TG Therapeutics Reports Positive Phase 3 ENHANCE Trial Results for BRIUMVI
- Trial Success: The ENHANCE Phase 3 trial successfully met its primary endpoint, demonstrating bioequivalence between a single 600 mg BRIUMVI infusion and the current dual dosing regimen of 150 mg and 450 mg, potentially simplifying treatment processes and improving patient adherence.
- Consistent Safety Profile: The safety and tolerability of the new regimen were consistent with the established safety profile of BRIUMVI, with no new safety signals observed during the trial, enhancing market confidence in the treatment's clinical application.
- Regulatory Filing Plans: TG Therapeutics plans to submit a supplemental Biologics License Application (BLA) in the second half of 2026, and if approved, BRIUMVI would become the first IV anti-CD20 therapy that can be initiated with a single infusion, further solidifying its market position.
- Improved Patient Experience: By eliminating the need for a second infusion, the new regimen simplifies the treatment process, expected to reduce patient scheduling burdens at busy infusion centers, aligning with the company's strategic goal of enhancing patient quality of life.
See More
TG Therapeutics Announces BRIUMVI Data Presentation Schedule at CMSC 2026
- Presentation Schedule: TG Therapeutics will showcase four data presentations on BRIUMVI at the 2026 Consortium of Multiple Sclerosis Centers annual meeting, emphasizing its clinical advantages in relapsing multiple sclerosis (RMS), which is expected to attract industry attention and enhance the company's reputation.
- Clinical Research Findings: New analyses from the ENABLE Phase 4 study indicate significant improvements in patient-reported outcomes, including treatment satisfaction and physical and psychological impact measures, observed as early as Day 15 and sustained through Week 48, highlighting BRIUMVI's long-term benefits for patient experience.
- Real-World Data: The data reveals that 99.4% of patients remained relapse-free after transitioning to BRIUMVI, with a low annualized relapse rate of 0.011, showcasing the drug's exceptional performance in disease control and patient satisfaction, potentially driving market share growth.
- Clinical Trial Background: The ULTIMATE I and II trials enrolled a total of 1,094 patients, demonstrating low rates of infusion-related reactions and consistent infusion times, further solidifying BRIUMVI's competitive edge in RMS treatment.
See More
ACT Capital Management Acquires New Position in Alumis Worth $4.36 Million
- New Position: On May 8, 2026, ACT Capital Management disclosed a new position in Alumis by acquiring 174,250 shares valued at approximately $4.36 million, indicating strong confidence in the company's future prospects.
- Quarterly Valuation: The position's valuation stood at $3.84 million at quarter-end, reflecting the impact of market price changes and share count, highlighting Alumis's significance in the investment portfolio.
- Stock Performance: Alumis shares surged 350% over the past year, significantly outperforming the S&P 500's 30% gain, showcasing its robust growth potential in the biopharmaceutical sector.
- Clinical Progress: Alumis reported positive Phase 3 data for moderate-to-severe plaque psoriasis in March, with plans to submit a New Drug Application in the second half of 2026, further boosting investor confidence in its drug development pipeline.
See More
