Tg Therapeutics Inc Stock Price, News & Analysis

TG Therapeutics (NASDAQ: TGTX) has announced upcoming presentations featuring BRIUMVI® (ublituximab-xiiy) data at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting in Phoenix, Arizona from May 28-31, 2025. The presentations include three key studies:

1. A platform presentation on the relationship between serum immunoglobulin levels and infections during long-term ublituximab treatment by Dr. Bruce Cree

2. A poster on infusion tolerability from the ENAMOR real-world observational survey presented by Dr. Edward Fox

3. A poster updating safety and tolerability data of 30-minute ublituximab infusions from the ENHANCE study by Dr. John Foley

All presentations are scheduled for May 29, 2025, and the data will be made available on TG Therapeutics' website after the presentations.

TG Therapeutics (NASDAQ: TGTX) reported strong Q1 2025 financial results, with BRIUMVI U.S. net revenue reaching $119.7 million, a 137% increase year-over-year. The company raised its 2025 guidance, targeting global net revenue of $575 million and U.S. BRIUMVI revenue of $560 million. Clinical data showed impressive results, with 92% of patients free from disability progression after five years of BRIUMVI treatment. The company reported a net income of $5.1 million in Q1 2025, compared to a $10.7 million loss in Q1 2024. Cash position stands at $276.2 million, with management confident in funding operations based on current projections. TG Therapeutics is advancing several initiatives, including subcutaneous BRIUMVI development and expansion into additional markets through partnership with Neuraxpharm.

TG Therapeutics has scheduled a conference call for Monday, May 5, 2025, at 8:30 AM ET to discuss their first quarter 2025 financial results and provide a business outlook for the remainder of the year. The call will be hosted by Michael S. Weiss, Chairman and Chief Executive Officer.

Participants can join the call using the following dial-in numbers:

• U.S.: 1-877-407-8029
• International: 1-201-689-8029

A live webcast will be available on the Events page in the Investors & Media section of www.tgtherapeutics.com. An audio recording will remain accessible for 30 days after the call on the company website. Financial results will be released via press release before the conference call.

TG Therapeutics (NASDAQ: TGTX) presented data for BRIUMVI® (ublituximab-xiiy) in treating relapsing forms of multiple sclerosis (RMS) at the American Academy of Neurology 2025 annual meeting. The ENHANCE trial demonstrated that a single 600 mg dose of BRIUMVI on Day 1 was well-tolerated, leading the company to consider a registration-directed trial to combine the currently approved Day 1 and Day 15 doses into a single administration.

Two key presentations were featured:

• Efficacy and Safety of Modified Ublituximab Regimen (ENHANCE) by Dr. John Foley
• Five-year Ublituximab results in Relapsing Multiple Sclerosis from ULTIMATE I and II Studies' open-label extension by Dr. Bruce Cree

TG Therapeutics (NASDAQ: TGTX) presented three significant data sets for BRIUMVI® (ublituximab-xiiy) in treating relapsing forms of multiple sclerosis (RMS) at the American Academy of Neurology 2025 annual meeting.

Key findings include:

• The ENAMOR survey, covering ~400 patients across 21 MS centers, showed improved tolerability and lower infusion-related reactions compared to Phase 3 trials
• 90% of surveyed patients received acetaminophen pre-medication, potentially explaining the better tolerance rates
• The company announced ENABLE, a new Phase 4 96-week observational study, which will track approximately 500 patients across 100 US MS centers
• Five-year BRIUMVI treatment data showed consistent serious infection rates with Phase 3 trials and no Progressive Multifocal Leukoencephalopathy (PML) cases

TG Therapeutics (NASDAQ: TGTX) has announced the publication of two significant journal articles focusing on BRIUMVI® (ublituximab-xiiy) in multiple sclerosis (MS) treatment. The first publication in Frontiers in Immunology presents a case series of seven MS patients who switched to BRIUMVI from other anti-CD20 therapies due to efficacy or tolerability issues.

The second article, published in CNS DRUGS, examines the evolution of anti-CD20 treatments for MS, discussing key characteristics such as scaffold, mechanism of action, and Fc engineering that may influence therapeutic efficacy and patient experience.

Michael S. Weiss, Executive Chairman and CEO, emphasized these publications provide rationale for switching patients within the CD20 class before abandoning it entirely. The company continues to study this phenomenon through their ongoing ENHANCE and ENABLE studies to further validate these initial findings.

TG Therapeutics (NASDAQ: TGTX) has announced upcoming presentations featuring BRIUMVI® (ublituximab-xiiy) data for relapsing multiple sclerosis (RMS) at the American Academy of Neurology 2025 annual meeting in San Diego (April 5-9, 2025).

The presentations include five poster sessions focusing on:

• Long-term ublituximab treatment's impact on immunoglobulin levels and serious infections
• Real-world infusion tolerability (ENAMOR survey)
• ENABLE Phase 4 observational study
• Five-year results from ULTIMATE I and II studies' open-label extension
• Modified ublituximab regimen (ENHANCE) efficacy and safety

Key researchers presenting include Dr. Bruce Cree from UC San Francisco's Weill Institute for Neurosciences, Dr. Ed Fox from TG Therapeutics, and Dr. John Foley from Rocky Mountain Multiple Sclerosis.

TG Therapeutics (NASDAQ: TGTX) reported strong financial results for Q4 and full year 2024, with BRIUMVI U.S. net revenue reaching $103.6 million in Q4 and $310 million for the full year, marking approximately 250% growth year-over-year.

Key highlights include:

• Target guidance of $540 million in total global revenue for 2025
• Extended BRIUMVI patent protection through 2042
• Successful European launch with partner Neuraxpharm
• Impressive 5-year clinical data showing 92% of patients free from disability progression

The company reported net income of $23.3 million for Q4 2024 and $23.4 million for the full year. Cash position stands at $311.0 million as of December 31, 2024. R&D expenses increased to $94.3 million for 2024, while SG&A expenses rose to $154.3 million, primarily due to BRIUMVI commercialization efforts.

TG Therapeutics (NASDAQ: TGTX) presented data from multiple studies of BRIUMVI® (ublituximab-xiiy) for relapsing multiple sclerosis (RMS) at the ACTRIMS annual forum. The presentations included:

1. Updated results from the ENHANCE Phase 3b trial showing consistent safety and tolerability in over 80 patients receiving 30-minute maintenance BRIUMVI doses

2. A real-world retrospective chart review by Dr. John Foley examining over 160 BRIUMVI-treated patients, confirming safety profiles consistent with ULTIMATE I & II Phase 3 trials and noting improvements in patients with suboptimal responses to prior anti-CD20 therapies

3. Additional presentations on Fc Biology and Genetic Diversity study design, and disease activity trajectories comparison between ublituximab and teriflunomide in ULTIMATE trials