TG Therapeutics, Inc. - TGTX STOCK NEWS

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.

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.