Positive Progress in BRIUMVI Subcutaneous Dosing Study
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 hours ago
0mins
Source: Newsfilter
- Clinical Trial Results: TG Therapeutics reported positive outcomes from its Phase 1 trial of subcutaneous BRIUMVI, with over 100 patients treated, demonstrating good tolerability and drug exposure, supporting the quarterly dosing regimen in the ongoing Phase 3 trial.
- Drug Bioavailability: Subcutaneous BRIUMVI showed over 60% bioavailability compared to IV administration, with the concentration-time profile indicating linear pharmacokinetics, expected to achieve non-inferiority over 24 weeks.
- Market Potential: If approved, BRIUMVI would be the first self-administered quarterly anti-CD20 therapy, potentially doubling the market opportunity and significantly reducing the number of injections required per year for patients.
- Future Outlook: TG Therapeutics anticipates releasing topline data from the Phase 3 trial by late 2026 or early 2027, and if successful, will advance towards potential approval, further solidifying its market position in multiple sclerosis treatment.
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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: 36.640
Low
15.00
Averages
43.50
High
60.00
Current: 36.640
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.
Positive Progress in BRIUMVI Subcutaneous Dosing Study
- Clinical Trial Results: TG Therapeutics reported positive outcomes from its Phase 1 trial of subcutaneous BRIUMVI, with over 100 patients treated, demonstrating good tolerability and drug exposure, supporting the quarterly dosing regimen in the ongoing Phase 3 trial.
- Drug Bioavailability: Subcutaneous BRIUMVI showed over 60% bioavailability compared to IV administration, with the concentration-time profile indicating linear pharmacokinetics, expected to achieve non-inferiority over 24 weeks.
- Market Potential: If approved, BRIUMVI would be the first self-administered quarterly anti-CD20 therapy, potentially doubling the market opportunity and significantly reducing the number of injections required per year for patients.
- Future Outlook: TG Therapeutics anticipates releasing topline data from the Phase 3 trial by late 2026 or early 2027, and if successful, will advance towards potential approval, further solidifying its market position in multiple sclerosis treatment.
See More
BRIUMVI Significantly Reduces Relapse Rate in Treatment-Naïve Patients
- Significant Relapse Reduction: BRIUMVI reduced the annualized relapse rate by 56.7% in treatment-naïve patients compared to teriflunomide, demonstrating its superior efficacy in multiple sclerosis treatment, which could shift clinical treatment standards.
- Improved Clinical Outcomes: Over 96 weeks, BRIUMVI showed a 2-fold greater confirmed disability improvement, particularly in early-treated patients with a 14.4% improvement rate, indicating that early intervention is crucial for long-term patient outcomes.
- Remarkable MRI Results: In treatment-naïve patients, BRIUMVI reduced gadolinium-enhancing T1 lesions by 96.1% and new/enlarging T2 lesions by 90.6%, showcasing its strong capability in controlling disease activity, which may enhance physician confidence in its use.
- Evidence of No Disease Activity: 82.7% of BRIUMVI-treated patients achieved no evidence of disease activity (NEDA-3), 3.6 times higher than teriflunomide patients, emphasizing the importance of BRIUMVI in early treatment and potentially driving its market acceptance.
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 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 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
Positive Progress in BRIUMVI Subcutaneous Dosing Study
- Clinical Trial Results: TG Therapeutics reported positive outcomes from its Phase 1 trial of subcutaneous BRIUMVI, with over 100 patients treated, demonstrating good tolerability and drug exposure, supporting the quarterly dosing regimen in the ongoing Phase 3 trial.
- Drug Bioavailability: Subcutaneous BRIUMVI showed over 60% bioavailability compared to IV administration, with the concentration-time profile indicating linear pharmacokinetics, expected to achieve non-inferiority over 24 weeks.
- Market Potential: If approved, BRIUMVI would be the first self-administered quarterly anti-CD20 therapy, potentially doubling the market opportunity and significantly reducing the number of injections required per year for patients.
- Future Outlook: TG Therapeutics anticipates releasing topline data from the Phase 3 trial by late 2026 or early 2027, and if successful, will advance towards potential approval, further solidifying its market position in multiple sclerosis treatment.
See More
BRIUMVI Significantly Reduces Relapse Rate in Treatment-Naïve Patients
- Significant Relapse Reduction: BRIUMVI reduced the annualized relapse rate by 56.7% in treatment-naïve patients compared to teriflunomide, demonstrating its superior efficacy in multiple sclerosis treatment, which could shift clinical treatment standards.
- Improved Clinical Outcomes: Over 96 weeks, BRIUMVI showed a 2-fold greater confirmed disability improvement, particularly in early-treated patients with a 14.4% improvement rate, indicating that early intervention is crucial for long-term patient outcomes.
- Remarkable MRI Results: In treatment-naïve patients, BRIUMVI reduced gadolinium-enhancing T1 lesions by 96.1% and new/enlarging T2 lesions by 90.6%, showcasing its strong capability in controlling disease activity, which may enhance physician confidence in its use.
- Evidence of No Disease Activity: 82.7% of BRIUMVI-treated patients achieved no evidence of disease activity (NEDA-3), 3.6 times higher than teriflunomide patients, emphasizing the importance of BRIUMVI in early treatment and potentially driving its market acceptance.
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 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 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
