TG Therapeutics Shares Rise 10% on Positive Trial Data for Briumvi
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 45 minutes ago
0mins
Source: seekingalpha
- Clinical Trial Progress: TG Therapeutics reported that the injectable version of Briumvi demonstrated over 60% bioavailability in early trials, strongly supporting the quarterly subcutaneous dosing regimen currently being tested in late-stage trials, which could significantly enhance market opportunities.
- Safety Assessment: The company noted that the injectable ublituximab was generally well tolerated, with treatment-emergent adverse events aligning with expectations for IV Briumvi, indicating that the new formulation's safety profile is comparable to existing treatments.
- Market Potential: If approved, the self-administered at-home option would drastically reduce the number of annual injections, potentially doubling Briumvi's addressable market opportunity and further solidifying its position in multiple sclerosis treatment.
- Future Outlook: CEO Michael Weiss emphasized that the current trial data bolsters confidence in achieving the primary endpoint for the quarterly subcutaneous dosing regimen, with plans to report Phase 3 trial data later this year or early next year, aiming for potential approval by 2028.
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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.
TG Therapeutics Shares Rise 10% on Positive Trial Data for Briumvi
- Clinical Trial Progress: TG Therapeutics reported that the injectable version of Briumvi demonstrated over 60% bioavailability in early trials, strongly supporting the quarterly subcutaneous dosing regimen currently being tested in late-stage trials, which could significantly enhance market opportunities.
- Safety Assessment: The company noted that the injectable ublituximab was generally well tolerated, with treatment-emergent adverse events aligning with expectations for IV Briumvi, indicating that the new formulation's safety profile is comparable to existing treatments.
- Market Potential: If approved, the self-administered at-home option would drastically reduce the number of annual injections, potentially doubling Briumvi's addressable market opportunity and further solidifying its position in multiple sclerosis treatment.
- Future Outlook: CEO Michael Weiss emphasized that the current trial data bolsters confidence in achieving the primary endpoint for the quarterly subcutaneous dosing regimen, with plans to report Phase 3 trial data later this year or early next year, aiming for potential approval by 2028.
See More
TG Therapeutics Reports Positive Clinical Data for Briumvi Injectable Formulation
- Positive Clinical Trial Results: TG Therapeutics announced favorable Phase 1 results for its injectable formulation of Briumvi, demonstrating comparable drug exposure and B-cell depletion levels to the existing IV version, indicating its potential as a more convenient treatment option that could attract more patients.
- Home Administration Dosage: The identified 400 mg dosage is deemed suitable for potential at-home administration via an autoinjector, which not only provides convenience for patients but also enhances the drug's market acceptance and sales potential.
- Investor Sentiment Shift: TG Therapeutics' stock surged 10% on Wednesday, rebounding from five consecutive days of declines as investors welcomed the positive clinical data for the injectable formulation, reflecting market confidence in the company's future growth prospects.
- Future Outlook: Top-line results from the Phase 3 trial are expected in late 2026 or early 2027, a timeline that will significantly impact the company's long-term strategy and market performance, particularly in the multiple sclerosis treatment sector.
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 Shares Rise 10% on Positive Trial Data for Briumvi
- Clinical Trial Progress: TG Therapeutics reported that the injectable version of Briumvi demonstrated over 60% bioavailability in early trials, strongly supporting the quarterly subcutaneous dosing regimen currently being tested in late-stage trials, which could significantly enhance market opportunities.
- Safety Assessment: The company noted that the injectable ublituximab was generally well tolerated, with treatment-emergent adverse events aligning with expectations for IV Briumvi, indicating that the new formulation's safety profile is comparable to existing treatments.
- Market Potential: If approved, the self-administered at-home option would drastically reduce the number of annual injections, potentially doubling Briumvi's addressable market opportunity and further solidifying its position in multiple sclerosis treatment.
- Future Outlook: CEO Michael Weiss emphasized that the current trial data bolsters confidence in achieving the primary endpoint for the quarterly subcutaneous dosing regimen, with plans to report Phase 3 trial data later this year or early next year, aiming for potential approval by 2028.
See More
TG Therapeutics Reports Positive Clinical Data for Briumvi Injectable Formulation
- Positive Clinical Trial Results: TG Therapeutics announced favorable Phase 1 results for its injectable formulation of Briumvi, demonstrating comparable drug exposure and B-cell depletion levels to the existing IV version, indicating its potential as a more convenient treatment option that could attract more patients.
- Home Administration Dosage: The identified 400 mg dosage is deemed suitable for potential at-home administration via an autoinjector, which not only provides convenience for patients but also enhances the drug's market acceptance and sales potential.
- Investor Sentiment Shift: TG Therapeutics' stock surged 10% on Wednesday, rebounding from five consecutive days of declines as investors welcomed the positive clinical data for the injectable formulation, reflecting market confidence in the company's future growth prospects.
- Future Outlook: Top-line results from the Phase 3 trial are expected in late 2026 or early 2027, a timeline that will significantly impact the company's long-term strategy and market performance, particularly in the multiple sclerosis treatment sector.
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
