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 commercial-stage biopharmaceutical company focused on B-cell diseases, with news flow centered on its CD20-targeted monoclonal antibody BRIUMVI (ublituximab-xiiy) for relapsing forms of multiple sclerosis (RMS). This news page aggregates company announcements, clinical data updates, financial results, and corporate presentations related to TGTX stock.
Recent press releases highlight preliminary and reported revenue from BRIUMVI, including disclosures that product revenue consists primarily of net product sales of BRIUMVI in the United States and sales to ex-U.S. partners. Investors can follow updates on revenue guidance, operating expense targets, and commentary on how BRIUMVI commercialization influences overall company performance.
TG Therapeutics also issues frequent news about its development programs. These items include progress in the ENHANCE Phase 3b trial evaluating a simplified intravenous dosing schedule for BRIUMVI, the Phase 3 pivotal program for subcutaneous ublituximab, and the Phase 1 trial of azer-cel, an allogeneic CD19 CAR T therapy in autoimmune disease. Additional releases cover long-term ULTIMATE I & II trial data, real-world ENABLE observational study outcomes, and schedules of data presentations at neurology and multiple sclerosis congresses.
Corporate news includes participation in major healthcare and biotechnology investor conferences, rankings such as the Deloitte Technology Fast 500, and announcements of share repurchase authorizations. By following this TGTX news feed, readers can monitor how clinical results, regulatory milestones, commercialization updates, and financial disclosures intersect for TG Therapeutics and its lead therapy BRIUMVI.
TG Therapeutics (NASDAQ: TGTX) will hold a conference call on November 4, 2021, at 8:30 AM ET to discuss Q3 2021 results and provide a business outlook for the remainder of the year. The call will be hosted by Michael S. Weiss, Chairman and CEO. Participants can join by calling the provided numbers, with a live webcast available on the company's website. A financial results press release will precede the call.
TG Therapeutics, Inc. (TGTX) announced significant data from the Phase 3 ULTIMATE I & II trials at ECTRIMS 2021, showing that ublituximab treatment resulted in a statistically significant reduction in annualized relapse rate (ARR) compared to teriflunomide. Key findings include an ARR of 0.076 vs. 0.188 in ULTIMATE I and 0.091 vs. 0.178 in ULTIMATE II, representing reductions of approximately 60% and 50%, respectively. Ublituximab also demonstrated notable improvements in the Multiple Sclerosis Functional Composite (MSFC) score, with data supporting a Biologics License Application (BLA) to the FDA for treating relapsing forms of multiple sclerosis.
TG Therapeutics, Inc. (NASDAQ: TGTX) has submitted a Biologics License Application (BLA) to the FDA for its investigational drug, ublituximab, to treat relapsing forms of multiple sclerosis (RMS). This submission is based on the successful Phase 3 ULTIMATE I & II trials, which showed ublituximab significantly reduced the annualized relapse rate compared to teriflunomide. The trials enrolled 1,094 patients across 10 countries and were conducted under a Special Protocol Assessment with the FDA. This marks TG Therapeutics' first marketing application for an autoimmune indication.
TG Therapeutics (TGTX) announced that both ULTIMATE I & II Phase 3 trials of ublituximab met their primary endpoints, demonstrating a statistically significant reduction in annualized relapse rate (ARR) over 96 weeks (p0.005). The findings will be presented at the ECTRIMS Congress on October 14, 2021. The trials involved 1,094 patients across 10 countries. Ublituximab, an investigational treatment, targets CD20+ B-cells and aims to improve outcomes for patients with relapsing multiple sclerosis (RMS). An investor event will discuss the trial data at 12:30 PM ET on the same day.
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.