TG Therapeutics' Subcutaneous BRIUMVI: A Game-Changer in MS Treatment and Market Expansion

TG Therapeutics’ BRIUMVI (ublituximab-xiiy) has emerged as a transformative force in the treatment of relapsing multiple sclerosis (RMS), with its subcutaneous formulation poised to redefine market dynamics. In Q2 2025, BRIUMVI generated $138.8 million in U.S. net revenue, reflecting a staggering 91.2% year-over-year increase and 16% sequential growth [1]. This performance has prompted the company to raise its full-year 2025 revenue guidance to $575–$585 million, underscoring robust physician and patient adoption [2]. However, the true investment thesis lies in the development of a subcutaneous delivery method—a strategic innovation that could unlock new revenue streams and solidify BRIUMVI’s dominance in the $30 billion MS market.

Clinical Differentiation and Market Traction

BRIUMVI’s clinical profile has already set it apart. Long-term data from an open-label extension study revealed that 92% of patients experienced no disability progression after five years of treatment, with an annualized relapse rate of just 0.02 [1]. These outcomes outperform competitors like Roche’s Ocrevus, which demonstrated a 47% reduction in relapse rate compared to interferon beta-1a, while BRIUMVI achieved an 80% reduction versus placebo [3]. The drug’s glycoengineered formulation and convenient intravenous (IV) dosing regimen—requiring only two infusions per year—have driven rapid market penetration. Yet, the subcutaneous version promises to address a critical unmet need: patient preference for self-administered therapies.

Subcutaneous Formulation: A Strategic Leap

TG Therapeutics has initiated a pivotal Phase 3 trial to evaluate subcutaneous BRIUMVI, comparing two dosing regimens (every 8 weeks and every 12 weeks) against the IV formulation [4]. Success in this trial would position BRIUMVI as the only anti-CD20 therapy offering both IV and subcutaneous administration options, a differentiation that could expand its market reach by an estimated 40% [5]. This is significant, as approximately 40% of RMS patients prefer self-injectable treatments over infusions [6]. The subcutaneous formulation also aligns with broader industry trends favoring patient-centric care and reduced healthcare system burdens.

Regulatory timelines suggest a potential approval by 2028, with a launch expected in 2028 [5]. This timeline is aggressive but achievable, given BRIUMVI’s existing regulatory approvals in the EU, UK, Switzerland, and Australia [3]. The company is also exploring streamlined IV dosing (consolidated Day 1 and Day 15 infusions) to further enhance convenience, with label updates anticipated in 2027 [5]. These innovations collectively reinforce BRIUMVI’s competitive moat in a market where patient adherence and treatment satisfaction are key drivers of long-term success.

Financial and Market Implications

The subcutaneous version could catalyze exponential revenue growth. At current U.S. net revenue of $138.8 million in Q2 2025, BRIUMVI’s full-year 2025 guidance of $575–$585 million implies a 91% year-over-year increase [2]. With subcutaneous adoption, analysts project the drug could capture an additional $400–$500 million annually by 2028, assuming 40% market penetration in the self-injectable segment [5]. This growth is further bolstered by BRIUMVI’s global expansion and exploration into progressive MS and myasthenia gravis, which could broaden its therapeutic footprint and diversify revenue streams [5].

TG Therapeutics has also prioritized marketing efforts, including a planned television advertising campaign in late 2025 to amplify patient awareness [3]. These initiatives, combined with real-world data demonstrating BRIUMVI’s efficacy and safety, are expected to drive market share gains against entrenched competitors like Ocrevus and Biogen’s Tecfidera.

Risks and Considerations

While the subcutaneous trial represents a high-conviction bet, investors must consider potential risks. Clinical trial failure, regulatory delays, or competition from emerging therapies could temper growth. However, the company’s strong revenue guidance and existing market traction—bolstered by a 92% no disability progression rate in long-term studies [1]—suggest a resilient foundation.

Conclusion

TG Therapeutics’ subcutaneous BRIUMVI exemplifies the power of innovation in addressing unmet medical needs while creating shareholder value. By bridging the gap between clinical excellence and patient convenience, the subcutaneous formulation has the potential to redefine RMS treatment paradigms and drive multiyear revenue growth. For investors, this represents a compelling opportunity in a high-growth therapeutic area, where strategic differentiation and execution can translate into sustained market leadership.

Source:
[1] TG Therapeutics Reports First Quarter 2025 Financial Results [https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-reports-first-quarter-2025-financial-results-and]
[2] TG Therapeutics Q2 Revenue Up 91% [https://www.nasdaq.com/articles/tg-therapeutics-q2-revenue-91]
[3] Briumvi vs Ocrevus: A Detailed Examination (2025) [https://www.dvcstem.com/post/briumvi-vs-ocrevus]
[4] TG Announces Phase 3 Trial for Subcutaneous BRIUMVI [https://www.globenewswire.com/news-release/2025/09/08/3146012/8790/en/TG-Announces-Phase-3-Trial-for-Subcutaneous-BRIUMVI-Commenced-Enrollment.html]
[5] TG Therapeutics, Inc. (TGTX) Q2 FY2025 Earnings Call Transcript [https://finance.yahoo.com/quote/TGTX/earnings/TGTX-Q2-2025-earnings_call-342112.html/]