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, Inc. (NASDAQ: TGTX) has announced an underwritten public offering of $200 million of its common stock, with an additional $30 million option for underwriters. The proceeds will be used for the development of ublituximab and umbralisib, potential acquisitions, and general corporate purposes. The offering is subject to market conditions and follows a shelf registration statement filed with the SEC. J.P. Morgan, Goldman Sachs, Evercore, and Cantor Fitzgerald are the joint book-running managers for this offering.
TG Therapeutics announced positive topline results from two Phase 3 studies, ULTIMATE I & II, evaluating ublituximab for patients with relapsing forms of multiple sclerosis (RMS). Both studies significantly reduced annualized relapse rate (ARR) to 0.10, with relative reductions of approximately 60% and 50% compared to teriflunomide (p<0.005). Ublituximab's safety and efficacy will support a submission targeted for mid-2021. The studies enrolled 1,094 patients globally and were conducted under FDA's Special Protocol Assessment.
TG Therapeutics (TGTX) announces promising results from the UNITY-CLL and UNITY-NHL clinical trials presented at the ASH 2020 meeting. The U2 combination therapy significantly improved progression-free survival (PFS) in CLL patients, showing a hazard ratio of 0.54 (p0.0001). In the UNITY-NHL trial, umbralisib monotherapy achieved an overall response rate (ORR) of 49.3% in MZL patients. Both therapies displayed manageable safety profiles with low incidence of severe adverse events. The company plans to submit regulatory applications, with deadlines set for early 2021.
TG Therapeutics (TGTX) revealed promising data from two triple therapy combinations for treating relapsed or refractory chronic lymphocytic leukemia (CLL) at the 62nd ASH annual meeting. A combination of umbralisib, ublituximab, and venetoclax (U2-Ven) demonstrated a 100% overall response rate (ORR) at cycle 12, with a 41% complete response (CR) rate. Additionally, U2 combined with TG-1701 showed a 79% ORR and a 22% CR rate. The trials highlight TGTX's commitment to advancing treatments for B-cell malignancies, potentially leading to better patient outcomes.
TG Therapeutics (NASDAQ: TGTX) announced data presentations for the 62nd American Society of Hematology (ASH) annual meeting, occurring virtually from December 5-8, 2020. Key presentations include:
- Phase 3 UNITY-CLL Study: Umbralisib plus Ublituximab shows superiority over Obinutuzumab plus Chlorambucil in treating CLL.
- Phase 2 UNITY-NHL Trial: Umbralisib exhibits clinical activity in relapsed/refractory indolent Non-Hodgkin Lymphoma.
- Phase 1/2 Study: Combines Umbralisib, Ublituximab, and Venetoclax in patients with CLL.
The data will be available on TG's corporate website post-presentation.
TG Therapeutics (TGTX) recently published data from a Phase 2 study on umbralisib, a dual inhibitor for CLL patients intolerant to other therapies, in Blood. The study involved 51 patients, highlighting a median progression-free survival (PFS) of 23.5 months. The most common adverse events included neutropenia (18%) and pneumonia (12%). Notably, 58% of patients sustained treatment longer than prior therapies. The company is committed to addressing unmet needs in CLL and is pursuing BLA submission for ublituximab combined with umbralisib.
TG Therapeutics (NASDAQ: TGTX) has initiated a rolling submission of a Biologics License Application (BLA) for ublituximab combined with umbralisib for treating chronic lymphocytic leukemia (CLL). The FDA previously granted Fast Track and Orphan Drug Designations for this combination. The BLA submission is expected to conclude in the first half of 2021. Additionally, umbralisib's NDA for relapsed/refractory marginal zone lymphoma and follicular lymphoma is under FDA review, with PDUFA dates set for February 15 and June 15, 2021, respectively.
TG Therapeutics will host a fireside chat on December 1, 2020, at 10:05 AM ET, featuring Executive Chairman and CEO Michael S. Weiss. This event is part of the 3rd Annual Evercore ISI HealthCONx Conference. Investors can access the live webcast on the company’s website.
The company is advancing treatments for B-cell malignancies and autoimmune diseases, focusing on investigational drugs ublituximab and umbralisib, known as “U2.” Umbralisib is currently under FDA review for treating specific lymphomas.
TG Therapeutics, Inc. (NASDAQ: TGTX) announced that Michael S. Weiss, Executive Chairman and CEO, will participate in a fireside chat on November 17, 2020, at 2:20 PM ET during the Jefferies Virtual London Healthcare Conference. A live webcast will be accessible on the company’s Events page. The company focuses on developing innovative treatments for B-cell malignancies and autoimmune diseases, with investigational compounds like ublituximab and umbralisib in late-stage clinical development.
TG Therapeutics (TGTX) reported its Q3 2020 financial results, highlighting significant advancements in its clinical trials. The UNITY-CLL Phase 3 trial achieved its primary endpoint, indicating improved progression-free survival. The NDA for umbralisib was accepted for MZL and FL, with PDUFA goal dates set for February and June 2021. The company boasts a proforma cash position of $325 million and plans to submit a BLA/NDA for U2 for CLL. R&D expenses decreased, while net loss widened to $87.2 million. A focus remains on upcoming ASH 2020 presentations and remaining 2020 milestones.