TG Therapeutics Advances Subcutaneous Briumvi With Strong Trial Results and Rising Sales Momentum

TG Therapeutics announced positive Phase 1 data for the subcutaneous version of Briumvi, a CD20 antibody for relapsing-remitting multiple sclerosis. The results not only met expectations but exceeded them in some areas. Bioavailability, safety, and tolerability were convincing and provide an important foundation for further program development. This brings a product closer that could nearly double the addressable market potential of Briumvi.

At the same time, TG Therapeutics continued its commercial expansion, addressing concerns about a potential slowdown in growth. Recent progress underscores that the company remains on track both operationally and clinically.

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Important milestone for subcutaneous Briumvi

The subcutaneous version of Briumvi is considered one of TG Therapeutics’ most important growth drivers for the coming years. The success of Novartis’ Kesimpta demonstrates that patients are increasingly opting for therapies that can be conveniently administered at home via autoinjector.

Until now, TG Therapeutics lacked a suitable product offering and thus access to a rapidly growing market segment. However, this could soon change. The Phase 3 trial of subcutaneous Briumvi has been fully recruited, and initial results are expected by the end of 2026 or the beginning of 2027. A market launch could follow in 2028.

The Phase 1 data presented now represent an important milestone. Bioavailability was over 60 percent compared to intravenous administration. Furthermore, modeling suggests that both bimonthly and quarterly administration should provide comparable drug exposure.

Efficacy and tolerability were also convincing. B-cell depletion was comparable to the intravenous variant, while local reactions at the injection site remained rare. Systemic reactions occurred in 21 percent of patients, which is on par with Kesimpta. No serious adverse events were observed.

The results suggest good chances of success in the phase 3 trial. Should the profile be confirmed, subcutaneous Briumvi, with its application frequency of only two months or quarters, could offer a significant convenience advantage over competing therapies.

At the same time, the market seems to have only partially priced in the potential of the subcutaneous variant so far. If development proceeds as expected, revenue growth should accelerate noticeably from 2028 onwards.

Simplified treatment could create additional demand

The intravenous form of Briumvi has also recently received a boost. The ENHANCE study investigated whether the previously separate infusions on day 1 and day 15 could be combined into a single treatment.

The study met its primary endpoint and confirmed comparable drug exposure between both treatment regimens. Safety data, B-cell depletion, and MRI results were also similar between the groups.

A particularly positive finding was that infusion-related reactions were even lower than in previous registration studies. In the combined treatment regimen, the values ​​were even slightly below those of the previous standard.

TG Therapeutics plans to submit the corresponding marketing authorization application to the US Food and Drug Administration in the second half of the year. The simplified treatment regimen could be introduced by mid-2027, further increasing the appeal of the intravenous option.

In the long term, however, the subcutaneous version is likely to have significantly greater strategic importance. Should it be successfully launched on the market, it could capture some of the future growth from the intravenous variant.

TG therapeutics sales growth is regaining momentum

Operationally, business continues to perform better than expected. In the first quarter, TG Therapeutics exceeded revenue forecasts and raised its full-year guidance for US sales of Briumvi to between $885 million and $900 million.

This trend suggests that the series of upward revisions to forecasts and positive surprises could continue throughout the year. Under this assumption, annual revenue estimates of $940 million to $960 million appear achievable.

Particularly encouraging is the renewed momentum of sequential revenue growth. After a period of slowdown, the most recent quarters show a clearly positive trend.

In contrast, the international business continues to perform significantly weaker. Marketing outside the US remains below expectations. Consequently, license revenues generated by partner Neuraxpharm were low in the first quarter. A noticeable improvement is not foreseeable in the short term. However, a takeover of Neuraxpharm by a larger pharmaceutical company, which was already speculated about at the beginning of the year, is considered a possible catalyst.

Pipeline and financial strength provide additional tailwinds for TG Therapeutics

In addition to the commercial success of Briumvi, TG Therapeutics is working on further applications for the drug. Furthermore, initial Phase 1 data for azer-cel in progressive multiple sclerosis are expected later this year.

The company is also in a comfortable financial position. Rising sales and improved profitability have expanded its financial flexibility and, among other things, enable share buybacks.

The development of new therapies for multiple sclerosis remains a key competitive factor. The market is particularly focused on the progress of BTK inhibitors. Roche recently reported strong efficacy data for fenebrutinib, although the program has been hampered by safety concerns. Further attention is now focused on Novartis and the drug remibrutinib, for which important study data are expected in the second half of the year.

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(Featured image by Louis Reed via Unsplash)

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