Welcome to our dedicated page for TG Therapeutics news (Ticker: TGTX), a resource for investors and traders seeking the latest updates and insights on TG Therapeutics stock.
TG Therapeutics, Inc. (NASDAQ: TGTX) is a biopharmaceutical company headquartered in New York City, dedicated to developing and commercializing innovative treatments for B-cell malignancies and autoimmune diseases. The company has a rich pipeline of products aimed at addressing unmet medical needs in these areas.
One of TG Therapeutics' flagship products is BRIUMVI® (ublituximab-xiiy), a novel monoclonal antibody targeting CD20-expressing B-cells. BRIUMVI is FDA-approved for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The company has also received approval from the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of RMS in Europe and the United Kingdom, respectively.
In addition to BRIUMVI, TG Therapeutics is advancing several other therapies:
- TG-1701 (BTK inhibitor)
- TG-1801 (anti-CD47/CD19 bispecific mAb)
Recent company news highlights the robust clinical activity of BRIUMVI, as demonstrated in the ULTIMATE I & II Phase 3 trials, and the company’s ongoing commitment to the multiple sclerosis community. TG Therapeutics has also been awarded a national contract with the Department of Veterans Affairs (VA) to list BRIUMVI as the preferred agent on the VA National Formulary for Anti-CD20 Antibody indications.
Financially, TG Therapeutics reported strong first-quarter 2024 sales, with BRIUMVI U.S. net revenue exceeding $50 million, leading to revised annual guidance of $270 to $290 million for 2024. The company is focused on expanding its commercial infrastructure and advancing its research pipeline, including developing a subcutaneous form of BRIUMVI and moving the therapy into additional indications beyond MS.
For more information, visit the company’s website at www.tgtherapeutics.com.
TG Therapeutics (NASDAQ: TGTX) has been ranked number one on the 2024 Deloitte Technology Fast 500™, which recognizes the fastest-growing companies in North America across technology, media, telecommunications, life sciences, fintech, and energy tech sectors. The company's exceptional growth between fiscal years 2020-2023 was driven by BRIUMVI® revenues, their multiple sclerosis treatment approved in December 2022 for adult patients with relapsing forms of the disease.
TG Therapeutics reported strong Q3 2024 financial results with BRIUMVI net revenue of $83.3 million, representing 15% quarter-over-quarter growth and 230% year-over-year increase. The company raised its full-year 2024 BRIUMVI revenue guidance to $300-305 million. Clinical data showed impressive 5-year results with 92% of patients free from disability progression and an annualized relapse rate of 0.02. The company secured FUJIFILM Diosynth as a secondary US manufacturer and reported Q3 net income of $3.9 million with a strong cash position of $341 million.
TG Therapeutics (NASDAQ: TGTX) has scheduled a conference call for Monday, November 4, 2024, at 8:30 AM ET to discuss their third quarter 2024 financial results and provide a business outlook. The call will be hosted by Chairman and CEO Michael S. Weiss. Financial results will be released before the call. Participants can join via phone (1-877-407-8029 U.S., 1-201-689-8029 international) or watch the live webcast on the company's website. An audio recording will be available for 30 days after the call.
TG Therapeutics (NASDAQ: TGTX) presented updated data from the ENHANCE Phase 3b trial of BRIUMVI® (ublituximab-xiiy) for relapsing forms of multiple sclerosis (RMS) at the 2024 ECTRIMS meeting. Key findings include:
1. Patients switching from prior anti-CD20 treatment can successfully eliminate the initial BRIUMVI infusion.
2. Rapid 30-minute BRIUMVI infusions are well-tolerated, with only mild (Grade 1) infusion-related reactions.
3. 97% of 1-hour infusions for B-cell depleted patients were completed without interruption.
4. 12 patients received 30-minute infusions at week 24, all completed without interruption.
The company aims to improve patient tolerability and convenience, potentially leading to label-enabling studies for optimized dosing regimens.
TG Therapeutics (NASDAQ: TGTX) presented updated 5-year data from the ULTIMATE I & II Phase 3 trials of BRIUMVI® (ublituximab-xiiy) in relapsing multiple sclerosis (RMS) at the 2024 ECTRIMS meeting. Key findings include:
- 92% of patients were free from disability progression after 5 years of BRIUMVI treatment
- Annualized relapse rate in year 5 was 0.020 (1 relapse per 50 patient-years)
- Safety profile remained consistent over 5 years with no new signals
- Patients who switched from teriflunomide to BRIUMVI saw a 58.4% reduction in relapse rate
- 17% of patients on continuous BRIUMVI achieved confirmed disability improvement
The data support BRIUMVI as a valuable long-term treatment option for RMS patients, demonstrating sustained clinical efficacy and a tolerable safety profile.
TG Therapeutics (NASDAQ: TGTX) has announced upcoming data presentations for BRIUMVI (ublituximab-xiiy) at the 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting. The presentations will highlight data from the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial, evaluating BRIUMVI in patients with relapsing forms of multiple sclerosis (RMS).
The meeting will be held from September 18-20, 2024, in Copenhagen, Denmark. Three poster presentations are scheduled, covering topics such as five-year results of ublituximab in RMS, efficacy and tolerability after transitioning from different therapies, and comparison of Multiple Sclerosis Disease Activity (MSDA) Test results between ublituximab and teriflunomide treatments.
HealthCare Royalty (HCRx) and Blue Owl Capital have provided a $250 million term loan facility to TG Therapeutics (NASDAQ: TGTX), a biopharmaceutical company focused on B-cell diseases. The loan, maturing on August 2, 2029, supports TG's commercialization of BRIUMVI®, an anti-CD20 monoclonal antibody for treating relapsing forms of multiple sclerosis. BRIUMVI® generated $89 million in U.S. net revenue in 2023. An additional $100 million facility is available at mutual option. This financing demonstrates confidence in TG Therapeutics' commercial progress and provides capital for its business objectives.
TG Therapeutics (NASDAQ: TGTX) reported strong Q2 2024 financial results, with U.S. BRIUMVI net revenue of $72.6 million, representing over 350% growth year-over-year. The company raised its full-year 2024 U.S. BRIUMVI net revenue guidance to $290-$300 million. TG Therapeutics achieved positive cash flow in Q2 2024 and established a $250 million credit facility to repay existing debt and initiate a share repurchase program. The company also made progress in its R&D pipeline, initiating a phase 1 study for subcutaneous ublituximab in RMS patients and receiving FDA IND clearance for azer-cel in progressive MS. With approximately 5,850 new patient prescriptions for BRIUMVI since launch, TG Therapeutics continues to show strong commercial momentum.
TG Therapeutics (NASDAQ: TGTX) has announced a conference call scheduled for Tuesday, August 6, 2024, at 8:30 AM ET to discuss the company's second quarter 2024 financial results and provide a business outlook for 2024. The call will be hosted by Michael S. Weiss, Chairman and CEO. Participants can join by calling 1-877-407-8029 (U.S.) or 1-201-689-8029 (outside U.S.). A live webcast will be available on the company's website, and an audio recording will be accessible for 30 days after the call. TG Therapeutics will release its financial results in a press release prior to the call.
TG Therapeutics (NASDAQ: TGTX) announced that CEO Michael S. Weiss will participate in the Goldman Sachs 45th Annual Global Healthcare Conference, held at the Loews Miami Beach Hotel, from June 10-13, 2024.
Weiss is scheduled for a fireside chat on June 11, 2024, at 1:20 PM ET. A live webcast will be available on the company's Investors & Media section.
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