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 announced the publication of safety results for UKONIQ® (umbralisib) in patients with relapsed lymphoid malignancies. The study, published in Blood Advances, included data from 371 patients, highlighting a low discontinuation rate due to adverse events, suggesting a favorable safety profile. UKONIQ is the first dual inhibitor of PI3K-delta and CK1-epsilon, now available for treating marginal zone and follicular lymphoma. The company aims for FDA approval of a combination treatment with ublituximab by March 25, 2022.
TG Therapeutics to Participate in Healthcare Conference
TG Therapeutics (NASDAQ: TGTX) announced that CEO Michael S. Weiss will join a fireside chat at the 2021 Cantor Virtual Healthcare Conference on September 27, 2021, at 10:40 AM ET. The conference runs from September 27 to 30, 2021. A live webcast will be available on the company's Events page, with a replay following the event. TG Therapeutics focuses on innovative treatments for B-cell malignancies and autoimmune diseases and has received FDA accelerated approval for UKONIQ®.
TG Therapeutics (NASDAQ: TGTX) announced a virtual event on September 20, 2021, at 8:30 AM ET to discuss updated data from their Phase 1 trial of U2 (umbralisib and ublituximab) combined with venetoclax for treating chronic lymphocytic leukemia (CLL). Highlights from the XIX International Workshop on Chronic Lymphocytic Leukemia were shared, demonstrating significant improvements in progression-free survival (PFS) and overall response rates (ORR) in these combinations. A PDUFA date for potential U2 regimen approval is set for March 25, 2022.
TG Therapeutics is set to host a virtual investor and analyst event on September 20, 2021, at 8:30 AM ET to discuss updated Phase 1 data for the combination of UKONIQ® (umbralisib) and ublituximab (U2) with venetoclax. This follows significant findings presented at the XIX International Workshop on Chronic Lymphocytic Leukemia with a reported 100% overall response rate among 46 patients with relapsed or refractory CLL. The event will also cover the ULTRA-V Phase 2/3 trial, highlighting the promising efficacy of the investigational treatment.
TG Therapeutics (NASDAQ: TGTX) announced that CEO Michael S. Weiss will participate in a fireside chat during the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The chat will be available for on-demand download starting at 7:00 AM ET on September 13, 2021, on the company's website. TG Therapeutics focuses on developing treatments for B-cell malignancies and autoimmune diseases, with several investigational medicines in various phases of clinical development.
TG Therapeutics, Inc. (NASDAQ: TGTX) announced four data presentations at the virtual XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL) from September 17 to 20, 2021. Key highlights include the Phase 3 UNITY-CLL study showing the superiority of its U2 therapy over competitors in treatment-naïve and relapsed forms of Chronic Lymphocytic Leukemia (CLL). Additionally, updated Phase 1 results of a triple combination therapy will be shared, which has led to the initiation of the ULTRA-V Phase 2/3 trial. The PDUFA date for U2 is March 25, 2022.
TG Therapeutics (TGTX) reported its Q2 2021 financial results, announcing net product revenue of $2.3M from UKONIQ, launched for specific lymphoma treatments. The FDA accepted a BLA and sNDA for the combination treatment (U2) targeting CLL, with a PDUFA date set for March 25, 2022. R&D expenses rose to $44.9M, largely due to milestone fees, while total SG&A expenses reached $34M. The net loss for the quarter was $78.5M. The company's cash position stood at $456.2M, expected to support operations into 2023.
TG Therapeutics (TGTX) announced a conference call on August 2, 2021, at 8:30 AM ET to discuss its second-quarter 2021 results and provide a business outlook. The call will be led by CEO Michael S. Weiss. Participants can join via phone or through a live webcast on the company's website. A financial results press release will precede the call. TG Therapeutics is focused on developing therapies for B-cell malignancies and autoimmune diseases, with significant advancements including FDA approval for UKONIQ® and ongoing Phase 3 programs.
TG Therapeutics, Inc. (NASDAQ: TGTX) announced that Michael S. Weiss, Chairman and CEO, will engage in a fireside chat at the Ladenburg Thalmann 2021 Healthcare Conference on July 14, 2021, at 12:30 PM ET. The event will be held virtually, and a live webcast will be available on the company's Events page. TG Therapeutics specializes in developing treatments for B-cell malignancies and autoimmune diseases and has received FDA accelerated approval for UKONIQ™.
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.
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