Tg Therapeutics Inc - TGTX STOCK NEWS

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.

TG Therapeutics (TGTX) reported its Q2 2021 financial results, announcing net product revenue of $2.3M from UKONIQ, launched for specific lymphoma treatments. The FDA accepted a BLA and sNDA for the combination treatment (U2) targeting CLL, with a PDUFA date set for March 25, 2022. R&D expenses rose to $44.9M, largely due to milestone fees, while total SG&A expenses reached $34M. The net loss for the quarter was $78.5M. The company's cash position stood at $456.2M, expected to support operations into 2023.

TG Therapeutics (TGTX) announced a conference call on August 2, 2021, at 8:30 AM ET to discuss its second-quarter 2021 results and provide a business outlook. The call will be led by CEO Michael S. Weiss. Participants can join via phone or through a live webcast on the company's website. A financial results press release will precede the call. TG Therapeutics is focused on developing therapies for B-cell malignancies and autoimmune diseases, with significant advancements including FDA approval for UKONIQ® and ongoing Phase 3 programs.

TG Therapeutics, Inc. (NASDAQ: TGTX) announced that Michael S. Weiss, Chairman and CEO, will engage in a fireside chat at the Ladenburg Thalmann 2021 Healthcare Conference on July 14, 2021, at 12:30 PM ET. The event will be held virtually, and a live webcast will be available on the company's Events page. TG Therapeutics specializes in developing treatments for B-cell malignancies and autoimmune diseases and has received FDA accelerated approval for UKONIQ™.

TG Therapeutics, Inc. (NASDAQ: TGTX) announced the passing of William J. Kennedy, PhD, a long-standing board member. His contributions significantly influenced the company's regulatory strategy. Kennedy held advanced degrees in biology and pharmacology and previously served as Executive Vice President at Zeneca Pharmaceuticals. He played a vital role in the FDA Modernization Act of 1997. TG Therapeutics focuses on developing treatments for B-cell malignancies and autoimmune diseases, with several investigational medicines in various stages of clinical development.

TG Therapeutics (TGTX) announced data from the Phase 3 ULTIMATE I & II trials highlighting the efficacy of ublituximab in relapsing multiple sclerosis (RMS). Ublituximab demonstrated a significant reduction in annualized relapse rates (ARR)—60% in ULTIMATE I (0.076 vs. 0.188) and 50% in ULTIMATE II (0.091 vs. 0.178). The studies also showed a 97% reduction in gadolinium-enhancing lesions and improved outcomes in patients achieving No Evidence of Disease Activity (NEDA). A BLA submission is targeted for Q3 2021, with no unexpected safety signals reported.

TG Therapeutics (NASDAQ: TGTX) announced findings from presentations on TG-1701, an oral BTK inhibitor, at the 16th ICML. The data included Phase 1 evaluations of TG-1701 as a monotherapy and in combination with ublituximab and umbralisib for treating non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Key results showed 100% overall response rate in CLL at 300 mg dosage and 95% in 200 mg monotherapy. Adverse events were manageable, with notable hypertension and bleeding-free results. TG-1701 is in vital clinical stages, aiming for advanced treatment options.

TG Therapeutics (NASDAQ: TGTX) announced promising data from its investigational oral BTK inhibitor, TG-1701, presented at the EHA Virtual Congress. This study involved 125 patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Notably, TG-1701 monotherapy achieved a 100% overall response rate (ORR) in a CLL cohort, with a 95% ORR in another. Safety data indicated good tolerability, though some patients experienced adverse events. The company continues to advance clinical development of TG-1701 and anticipates further evaluations.

TG Therapeutics (NASDAQ: TGTX) will present data at the 16th International Congress on Malignant Lymphoma (ICML) virtually from June 18–22, 2021. Key presentations include:

• TG-1701, a selective BTK inhibitor, as monotherapy and in combination with Ublituximab and Umbralisib in B-cell malignancies.
• Antitumoral activity of TG-1701 linked to disruption of Ikaros signaling.

Details are available in the ICML abstract book and will be published on the company’s website during the presentations.