NASDAQ:TGTX

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TG Therapeutics Soars 10% as Positive Subcutaneous BRIUMVI Data Expands Multi-Billion-Dollar Market Opportunity

TG Therapeutics (TGTX) jumped 10% after announcing positive Phase 1 results for a subcutaneous version of its multiple sclerosis treatment BRIUMVI, strengthening investor confidence in a potential product expansion that could significantly increase the drug's long-term commercial opportunity.

The company reported that its investigational high-concentration subcutaneous formulation of BRIUMVI demonstrated favorable pharmacokinetic, pharmacodynamic, safety, and tolerability results. Importantly, the data support a quarterly dosing regimen currently being evaluated in a fully enrolled Phase 3 trial, with topline results expected by late 2026 or early 2027.

Investors appear particularly excited about the commercial implications. Management stated that, if approved, subcutaneous BRIUMVI would become the first and only self-administered, at-home quarterly anti-CD20 therapy for multiple sclerosis patients. Such a product could offer significantly greater convenience than existing infusion-based treatments while reducing the number of annual administrations required.

The Phase 1 study showed strong drug exposure levels, sustained B-cell depletion comparable to the currently approved intravenous formulation, and a favorable safety profile with no new safety signals identified. Injection-site reactions were infrequent, and the treatment was generally well tolerated across more than 100 patients treated in the trial.

Perhaps most importantly for investors, management believes a successful subcutaneous formulation could nearly double the addressable market opportunity for the BRIUMVI franchise by expanding into the self-administered segment of the anti-CD20 market. The company noted that the ongoing Phase 3 trial is designed to demonstrate non-inferior drug exposure compared with intravenous BRIUMVI, and the Phase 1 data suggest both dosing regimens being tested are likely to meet that endpoint.

The market is likely looking beyond the current multiple sclerosis business and focusing on the possibility that TG Therapeutics could transform BRIUMVI into a more convenient, at-home therapy that competes more effectively across a broader patient population. With Phase 3 results expected within the next year and a potential approval path targeting 2028, investors appear to be assigning greater value to the company's long-term growth prospects.

Overall, the sharp rally reflects growing confidence that TG Therapeutics may be on track to create a differentiated multiple sclerosis franchise with significant commercial upside, supported by encouraging clinical data and a potentially market-expanding new formulation.
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Global Finance News 06-03-26
TG Therapeutics Shareholders Approve All 2025 Annual Meeting Proposals

TG Therapeutics, Inc. conducted its 2025 Annual Meeting of Stockholders on June 12 via an online platform, with 74.58% of outstanding shares represented. All four proposals on the ballot received shareholder approval.

Six directors, including CEO Michael S. Weiss, were re-elected, though some—such as Dr. Sagar Lonial and Yann Echelard—faced notable opposition, receiving around 54% and 59% of votes in favor, respectively.

Shareholders also ratified KPMG LLP as the company’s auditor for 2025 and approved the executive compensation plan in a close advisory vote. Additionally, they approved an amendment to the 2022 Incentive Plan, increasing the authorized share count from 17 million to 22 million.
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ME NEWS 06-16-25
TG Therapeutics raises full-year BRIUMVI revenue guidance after strong Q1 growth

• Q1 2025 BRIUMVI U.S. net revenue: $119.7 million (up ~137% YoY)
• Q1 2025 Total revenue: $120.9 million (up from $63.5 million YoY)
• Q1 Net income: $5.1 million vs. net loss of $10.7 million in Q1 2024
• R&D expense: $46.4 million (up from $32.7 million)
• SG&A expense: $50.3 million (up from $34.6 million)
• Cash and equivalents: $276.2 million as of March 31, 2025
Updated 2025 Guidance:
• BRIUMVI U.S. net revenue: Raised to $560 million (from $525 million)
• Global revenue: Raised to $575 million (from $540 million)
• Q2 2025 U.S. net revenue target: $135 million
• Operating expense (excluding COGS and non-cash comp): ~$300 million
• Cash position expected to support operations under current plan
Product & Pipeline Developments:
• BRIUMVI now available in additional European markets via partner Neuraxpharm
• Five-year ULTIMATE I & II extension data showed:
o 92% of patients free from disability progression
o Annualized relapse rate of 0.02 in year 5
o No new safety signals or PML cases
• ENHANCE Phase 3b trial data supported simplified dosing regimens and rapid 30-minute infusions
• Pipeline milestones:
o Subcutaneous BRIUMVI pivotal program to commence
o Pivotal trial for improved IV dosing regimen to launch
o Enrollment underway for trials in myasthenia gravis and progressive MS with BRIUMVI and azer-cel
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WS Investor 05-05-25
TG Therapeutics reported strong financial performance for 2024, driven by the success of BRIUMVI, a treatment for relapsing multiple sclerosis. The company achieved $103.6 million in U.S. net revenue for BRIUMVI in the fourth quarter and $310 million for the full year, reflecting significant growth. It set a 2025 revenue target of approximately $540 million, with $525 million expected from BRIUMVI sales in the U.S.

Key developments include the expansion of BRIUMVI’s patent protection through 2042, its commercial launch in Europe, and promising five-year data showing sustained efficacy and safety. Clinical trials for a subcutaneous version of BRIUMVI and its application for autoimmune diseases are underway. The company also entered a licensing agreement for an allogeneic CD19 CAR T therapy.

Financially, TG Therapeutics reported net product revenue of $313.7 million for 2024, a significant increase from $92 million in 2023. Net income was $23.3 million for the year, compared to $12.7 million in 2023. Research and development expenses rose to $94.3 million due to new trials and licensing costs. The company ended 2024 with $311 million in cash and investment securities, expecting this to support ongoing operations.

A conference call was scheduled for March 3, 2025, to discuss these results. The company remains focused on expanding BRIUMVI’s reach, developing new treatment options, and achieving key clinical milestones in 2025.
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WS News 03-03-25