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, Inc. (NASDAQ: TGTX) announced the passing of William J. Kennedy, PhD, a long-standing board member. His contributions significantly influenced the company's regulatory strategy. Kennedy held advanced degrees in biology and pharmacology and previously served as Executive Vice President at Zeneca Pharmaceuticals. He played a vital role in the FDA Modernization Act of 1997. TG Therapeutics focuses on developing treatments for B-cell malignancies and autoimmune diseases, with several investigational medicines in various stages of clinical development.
TG Therapeutics (TGTX) announced data from the Phase 3 ULTIMATE I & II trials highlighting the efficacy of ublituximab in relapsing multiple sclerosis (RMS). Ublituximab demonstrated a significant reduction in annualized relapse rates (ARR)—60% in ULTIMATE I (0.076 vs. 0.188) and 50% in ULTIMATE II (0.091 vs. 0.178). The studies also showed a 97% reduction in gadolinium-enhancing lesions and improved outcomes in patients achieving No Evidence of Disease Activity (NEDA). A BLA submission is targeted for Q3 2021, with no unexpected safety signals reported.
TG Therapeutics (NASDAQ: TGTX) announced findings from presentations on TG-1701, an oral BTK inhibitor, at the 16th ICML. The data included Phase 1 evaluations of TG-1701 as a monotherapy and in combination with ublituximab and umbralisib for treating non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Key results showed 100% overall response rate in CLL at 300 mg dosage and 95% in 200 mg monotherapy. Adverse events were manageable, with notable hypertension and bleeding-free results. TG-1701 is in vital clinical stages, aiming for advanced treatment options.
TG Therapeutics (NASDAQ: TGTX) announced promising data from its investigational oral BTK inhibitor, TG-1701, presented at the EHA Virtual Congress. This study involved 125 patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Notably, TG-1701 monotherapy achieved a 100% overall response rate (ORR) in a CLL cohort, with a 95% ORR in another. Safety data indicated good tolerability, though some patients experienced adverse events. The company continues to advance clinical development of TG-1701 and anticipates further evaluations.
TG Therapeutics (NASDAQ: TGTX) will present data at the 16th International Congress on Malignant Lymphoma (ICML) virtually from June 18–22, 2021. Key presentations include:
- TG-1701, a selective BTK inhibitor, as monotherapy and in combination with Ublituximab and Umbralisib in B-cell malignancies.
- Antitumoral activity of TG-1701 linked to disruption of Ikaros signaling.
Details are available in the ICML abstract book and will be published on the company’s website during the presentations.
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.
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