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 (TGTX) reported promising clinical data for its investigational oral BTK inhibitor, TG-1701, presented at the ASCO Annual Meeting. The monotherapy showed a 100% overall response rate (ORR) in patients with chronic lymphocytic leukemia (CLL) at 300 mg QD (n=19). The triple combination therapy with ublituximab and UKONIQ (U2) yielded a 79% ORR and a 21% complete response (CR) rate. The safety profile was generally tolerable, with early signs of complete responses in the combination therapy. TG Therapeutics aims to continue enrollment and present more data.
TG Therapeutics, Inc. (NASDAQ: TGTX) announced its participation in three virtual investor conferences in June 2021. Executive Chairman and CEO Michael S. Weiss will engage in a fireside chat at the Jefferies Virtual Healthcare Conference on June 1 at 2:00 PM ET, followed by another chat at the Goldman Sachs 42nd Annual Global Healthcare Conference on June 8 at 1:20 PM ET. Additionally, Weiss will present at the Raymond James Human Health Innovation Conference on June 22 at 10:00 AM ET. Live webcasts will be available on the Company’s website.
TG Therapeutics announced the acceptance of its Biologics License Application (BLA) by the FDA for ublituximab in combination with UKONIQ as a treatment for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The PDUFA goal date is set for March 25, 2022. This acceptance marks a significant milestone for the company, advancing its mission to offer novel treatment options for patients. The BLA was based on the successful UNITY-CLL Phase 3 trial, which showed positive results and received Fast Track and orphan drug designations.
TG Therapeutics, Inc. (NASDAQ: TGTX) announced its schedule for data presentations at the upcoming ASCO and EHA annual meetings, focusing on TG-1701, a selective BTK inhibitor. The ASCO presentation will detail TG-1701's efficacy as monotherapy and in combination with Ublituximab and Umbralisib (U2) for chronic lymphocytic leukemia (CLL) and lymphoma. The EHA presentation will also cover similar findings. CEO Michael S. Weiss expressed enthusiasm over continuing positive data and its implications for treatment in CLL.
TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for Q1 2021, highlighting significant milestones in its product pipeline. The company received FDA approval for UKONIQ, which is now commercially launched, yielding $0.8 million in product revenue. R&D expenses surged to $63.1 million primarily due to licensing fees, while SG&A expenses rose to $26.8 million due to commercial launch preparations. The net loss expanded to $90.6 million. TG Therapeutics ended the quarter with $523.8 million in cash, sufficient to fund operations into 2023.
TG Therapeutics (NASDAQ: TGTX) has scheduled a conference call for May 10, 2021, at 8:30 AM ET to discuss its Q1 2021 financial results and provide a business outlook. The call will be led by Executive Chairman and CEO Michael S. Weiss. Participants can join the call by dialing the designated numbers or via a live webcast on the company's website. TG Therapeutics is focused on novel treatments for B-cell malignancies and autoimmune diseases, with several investigational medicines currently in development, including UKONIQ™, which has received accelerated FDA approval.
TG Therapeutics (NASDAQ: TGTX) announced that CEO Michael S. Weiss will participate in a fireside chat at the B. Riley Securities Neuroscience Conference on April 28, 2021, at 9:00 AM ET. The event will be held virtually, and a live webcast will be available on the company’s website. TG Therapeutics focuses on developing treatments for B-cell malignancies and autoimmune diseases, with an active research pipeline and FDA-approved UKONIQ™ for specific lymphoma treatments.
Samsung Biologics and TG Therapeutics have expanded their contract manufacturing partnership for ublituximab, an investigational anti-CD20 monoclonal antibody. TG Therapeutics has submitted a Biologics License Application (BLA) to the FDA for ublituximab combined with UKONIQ for chronic lymphocytic leukemia (CLL) treatment, following positive Phase 3 trial results. Samsung is also building its largest biomanufacturing facility, set to boost global capacity. Ublituximab results from advanced glycoengineering aimed at enhancing treatment efficacy against B-cell malignancies.
TG Therapeutics (TGTX) has completed patient enrollment in the ULTRA-V Phase 2 trial and is initiating the ULTRA-V Phase 3 trial for patients with chronic lymphocytic leukemia (CLL). The Phase 3 trial will evaluate a triple combination therapy of UKONIQ™, ublituximab, and venetoclax. The primary endpoint is Progression-free Survival (PFS). Approximately 165 patients have been enrolled in the Phase 2 trial. The company looks forward to presenting Phase 2 results at future medical meetings, with further development and regulatory plans hinging on these outcomes.
TG Therapeutics announced positive results from its Phase 3 trials, ULTIMATE I & II, for ublituximab versus teriflunomide in relapsing multiple sclerosis (RMS). Ublituximab showed a statistically significant reduction in annualized relapse rates, achieving a 60% reduction in ULTIMATE I (ARR: 0.076 vs. 0.188) and 50% reduction in ULTIMATE II (ARR: 0.091 vs. 0.178). MRI results revealed a 97% reduction in enhancing lesions. Ublituximab was well tolerated, with plans for a BLA submission in Q3 2021.
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