Tg Therapeutics Inc - TGTX STOCK NEWS

TG Therapeutics, Inc. (NASDAQ: TGTX) announced its underwritten public offering of 6,320,000 shares of common stock at $43.50 per share, aiming for gross proceeds of approximately $275 million before expenses. The offering size was increased from the previously announced $200 million. The proceeds will fund the development of ublituximab and umbralisib, acquire new pharmaceutical products, and cover general corporate expenses. Closing is expected on December 17, 2020, pending customary conditions.

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 Biologics License Application (BLA) 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 (p<0.0001). 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.