Tg Therapeutics Inc - TGTX STOCK NEWS

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.

TG Therapeutics (NASDAQ: TGTX) announced promising results from its UNITY-CLL and UNITY-NHL trials, highlighting the efficacy of the U2 combination therapy in chronic lymphocytic leukemia (CLL). The U2 therapy showed a significant increase in progression-free survival (PFS) compared to obinutuzumab plus chlorambucil (HR=0.54, p<0.0001). Additionally, umbralisib monotherapy displayed a 49.3% overall response rate (ORR) in relapsed/refractory marginal zone lymphoma. The company will discuss these findings in a conference call on November 5, 2020.

TG Therapeutics has announced the acceptance of four abstracts for presentation at the 62nd American Society of Hematology (ASH) meeting, scheduled for December 5-8, 2020. The abstracts highlight key data from registration-directed trials of ublituximab and umbralisib, including results from the UNITY-CLL Phase 3 trial. An NDA for umbralisib monotherapy is under review, with a BLA/NDA submission for the U2 combination planned in coming months. A Zoom conference call with trial investigators will occur on November 5, 2020, at 8:45 AM ET.

TG Therapeutics, on October 21, 2020, announced that the FDA granted Fast Track Designation for its U2 combination therapy, ublituximab and umbralisib, aimed at treating chronic lymphocytic leukemia (CLL). This designation facilitates expedited development and regulatory review, addressing significant unmet medical needs for CLL patients. The Fast Track application was backed by positive data from the UNITY-CLL Phase 3 trial, which met its primary endpoint of progression-free survival. Data presentation from this trial is expected later this year, supporting regulatory submission.

TG Therapeutics (NASDAQ: TGTX) will participate in two virtual investor conferences. CEO Michael S. Weiss is scheduled for fireside chats at the H.C. Wainwright 22nd Annual Global Investment Conference on September 14, 2020, at 1:30 PM ET, and at the Cantor Fitzgerald Global Healthcare Conference on September 16, 2020, at 10:40 AM ET. Live webcasts of the presentations will be available on the company’s website. TG Therapeutics focuses on developing treatments for B-cell malignancies and autoimmune diseases, with two investigational compounds currently in late-stage clinical development.

TG Therapeutics, Inc. (NASDAQ: TGTX) announced that the FDA has accepted its New Drug Application for umbralisib, a dual inhibitor for marginal zone lymphoma (MZL) and follicular lymphoma (FL). The FDA granted the MZL indication Breakthrough Therapy Designation and set a PDUFA goal date of February 15, 2021, while the FL indication has a goal date of June 15, 2021. The NDA is based on UNITY-NHL Phase 2b trial data, which showed an overall response rate (ORR) of 40-50% for both MZL and FL cohorts. The acceptance is a significant step towards providing treatment options for patients with B-cell malignancies.

TG Therapeutics (TGTX) announced the publication of preclinical data on umbralisib, its dual PI3K-delta and CK1-epsilon inhibitor, in Blood Advances. CEO Michael S. Weiss highlighted the encouraging safety profile observed in clinical trials, suggesting a differentiated safety mechanism due to umbralisib’s unique immunomodulatory effects. The study revealed that umbralisib maintained Treg function better than other inhibitors, with significant implications for treating CLL. The data supports the ongoing Phase 3 trials for both umbralisib and ublituximab in hematological malignancies.

TG Therapeutics announced that Executive Chairman and CEO Michael S. Weiss will present at the Raymond James 2020 Human Health Innovation Conference on June 18, 2020, at 3:40 PM ET. The conference will be held virtually, and a live webcast of the presentation can be accessed via the Company's website.

TG Therapeutics focuses on developing treatments for B-cell malignancies and autoimmune diseases. Its key therapies include ublituximab and umbralisib, currently in Phase 3 clinical trials.

TG Therapeutics (NASDAQ: TGTX) presented promising data at the 25th European Hematology Association annual congress. Key highlights include ongoing favorable results for TG-1701, a selective BTK inhibitor in various B-cell malignancies, showing a 92% overall response rate in CLL patients. The combination therapy of umbralisib and ibrutinib also exhibited a 95% response rate for CLL with no delayed toxicities, emphasizing the potential for effective dual-targeted treatment approaches.