Tg Therapeutics Inc Stock Price, News & Analysis

TG Therapeutics (NASDAQ: TGTX) announced completion of enrollment in the randomized cohort of the Phase 3 ENHANCE trial testing a consolidated Day 1/Day 15 IV dosing schedule for BRIUMVI (ublituximab) in relapsing multiple sclerosis (RMS) on Oct 28, 2025.

The trial's primary endpoint is noninferior exposure measured by AUC at Week 16. ENHANCE is randomized, double-blind and placebo-controlled and will assess pharmacokinetics, safety (including infusion-related reactions), and efficacy via T1 Gd-enhancing lesions. Dosing arms compare a single 600 mg Day 1 dose plus Day 15 placebo versus 150 mg Day 1 then 450 mg Day 15, with a 450 mg dose at Week 24.

Company commentary notes potential for a simplified regimen to improve patient convenience and infusion center efficiency and states that, if data are positive, the regimen could be ready for launch in 2027.

TG Therapeutics (NASDAQ: TGTX) announced impressive 6-year data for BRIUMVI® (ublituximab-xiiy) in treating relapsing multiple sclerosis (RMS). The data revealed that 89.9% of patients remained free from disability progression after 6 years of continuous treatment.

Key highlights include an exceptionally low annualized relapse rate of 0.012 in year 6 (equivalent to one relapse per 83 years of treatment), and 17% of continuous BRIUMVI patients achieved Confirmed Disability Improvement. The ENHANCE study demonstrated that a modified single-dose regimen was well-tolerated, while the ENABLE real-world study showed an on-treatment relapse rate of 0.015, with 99.5% of participants reporting no relapses.

TG Therapeutics (NASDAQ: TGTX) has announced three upcoming presentations featuring BRIUMVI® (ublituximab-xiiy) data for multiple sclerosis at the 2025 ECTRIMS annual meeting in Barcelona, Spain from September 24-26, 2025.

The presentations include: 1) An oral presentation on long-term efficacy and safety data from six years of the ULTIMATE I and II trials' open-label extension, 2) An ePoster on safety and tolerability from the ENHANCE study with modified dosing regimen, and 3) An ePoster presenting real-world clinical experience from the ENABLE Phase 4 observational study.

All presentations will be available on the company's website after the conference.

TG Therapeutics (NASDAQ: TGTX) has initiated enrollment in a Phase 3 trial evaluating subcutaneous BRIUMVI for relapsing multiple sclerosis (RMS). The trial aims to develop a self-administered version of BRIUMVI, which is currently approved as an intravenous (IV) infusion.

The study will compare two subcutaneous dosing regimens (every 8 weeks and every 12 weeks) against the current IV format. If successful, BRIUMVI would become the only anti-CD20 therapy offering both IV and subcutaneous options, potentially accessing an additional 40% of the RMS CD20 market that prefers self-injectable treatments. The company anticipates potential approval by 2028.

TG Therapeutics (NASDAQ:TGTX) announced its participation in the upcoming H.C. Wainwright 27th Annual Global Investment Conference in New York, NY. The company's Chairman and CEO, Michael S. Weiss, will engage in a fireside chat on Monday, September 8, 2025, at 10:30am ET.

Investors can access a live webcast of the presentation through the Events page in the Investors & Media section of TG Therapeutics' website at http://ir.tgtherapeutics.com/events.

TG Therapeutics (NASDAQ: TGTX) has completed its previously announced $100 million share repurchase program, having bought back approximately 3.5 million shares at an average price of $28.55 per share. The program, which was initiated in August 2024, has now been fully executed, with approximately $78 million of stock repurchased in August alone.

The company's Board of Directors has authorized a new $100 million share repurchase program, which will be executed through open market purchases and private transactions. Management believes current market prices undervalue BRIUMVI's multibillion-dollar potential and the company's long-term growth prospects.

TG Therapeutics (NASDAQ:TGTX) announced its participation in the upcoming Cantor Global Healthcare Conference in New York, NY from September 3-5, 2025. Michael S. Weiss, the company's Chairman and CEO, will engage in a fireside chat on Wednesday, September 3, 2025, at 10:20am ET.

Investors can access a live webcast of the presentation through the Events page in the Investors & Media section of TG Therapeutics' website.

TG Therapeutics (NASDAQ: TGTX) reported strong Q2 2025 financial results, with total revenue reaching $141.1 million, primarily driven by BRIUMVI U.S. net revenue of $138.8 million - representing 91% growth year-over-year and 16% growth over Q1 2025.

The company raised its full-year 2025 guidance, now targeting BRIUMVI U.S. net revenue of $570-575 million and total global revenue of approximately $585 million. TG Therapeutics achieved net income of $28.2 million for Q2 2025 and reported a strong cash position of $278.9 million.

Key developments include BRIUMVI's expansion outside the U.S., with approvals in the EU, UK, Switzerland, and Australia. The company is advancing its pipeline with new clinical trials, including a Phase 3 program for consolidated BRIUMVI dosing and development of a subcutaneous formulation.

TG Therapeutics (NASDAQ: TGTX) has scheduled a conference call for Monday, August 4, 2025, at 8:30 AM ET to discuss their second quarter 2025 financial results and provide a business outlook. The call will be hosted by Michael S. Weiss, Chairman and Chief Executive Officer.

Investors can join via phone at 1-877-407-8029 (U.S.) or 1-201-689-8029 (international). A live webcast will be available on the company's website, and an audio recording will be accessible for 30 days afterward. Financial results will be released prior to the call.