Tg Therapeutics Inc - TGTX STOCK NEWS

TG Therapeutics, Inc. (TGTX) announced that its CEO, Michael S. Weiss, will present at the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022, at 9:45 AM ET. The event aims to highlight the company’s advancements in novel treatments for B-cell malignancies and autoimmune diseases. TG Therapeutics has received FDA accelerated approval for UKONIQ®, targeting specific lymphoma patients, and is progressing with three Phase 3 programs and several Phase 1 investigational medicines. A live webcast will be accessible on their website.

TG Therapeutics has announced an amendment to its term loan facility with Hercules Capital, increasing the facility size to $200 million, with $70 million funded at closing. This strategic move aims to enhance financial flexibility and strengthen the company's balance sheet as it approaches key FDA approvals for its drug candidates, particularly the combination therapy of ublituximab and umbralisib for chronic lymphocytic leukemia.

The amendment allows for additional funding contingent on FDA approvals.

TG Therapeutics (TGTX) recently presented data from the UNITY-CLL Phase 3 trial at the 63rd ASH annual meeting. This trial evaluated the efficacy of the U2 combination therapy, consisting of ublituximab and umbralisib, in treating chronic lymphocytic leukemia (CLL) patients. The study enrolled 210 patients, highlighting significant results among treatment-naïve patients, with a progression-free survival (PFS) of 38.5 months and an overall response rate (ORR) of 84%. In previously treated patients, PFS was 19.5 months with an ORR of 82%. The findings support U2's potential for patients with co-morbidities.

TG Therapeutics (NASDAQ: TGTX) announced the acceptance of its Biologics License Application (BLA) for ublituximab, a monoclonal antibody targeting CD20, by the FDA as a treatment for relapsing forms of multiple sclerosis (RMS). The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of September 28, 2022, for its review. The application is based on successful results from the ULTIMATE I & II Phase 3 trials, which demonstrated significant efficacy over teriflunomide. This marks TG Therapeutics' first marketing application for an autoimmune indication.

TG Therapeutics, Inc. (NASDAQ: TGTX) presented four data presentations during the 63rd American Society of Hematology (ASH) annual meeting, focusing on the investigational therapies U2 (ublituximab and umbralisib) and TG-1701. Key results include a 70% overall response rate in relapsed/refractory marginal zone lymphoma patients and significant findings in chronic lymphocytic leukemia therapy. The company aims to enhance patient care for B-cell malignancies through ongoing research. The results highlight the potential of U2-based therapies for improving treatment outcomes.

TG Therapeutics, Inc. (NASDAQ: TGTX) announced the schedule for data presentations at the 63rd American Society of Hematology (ASH) annual meeting from December 11-14, 2021. Key oral presentations include the efficacy of U2 (Umbralisib and Ublituximab) in treating various hematologic malignancies. Presentations focus on relapsed/refractory marginal zone lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. The company continues to advance its pipeline, including the accelerated FDA approval of UKONIQ® for specific lymphoma treatments.

TG Therapeutics announced that the FDA plans to hold an Oncologic Drugs Advisory Committee (ODAC) meeting regarding the BLA/sNDA for the combination of ublituximab and UKONIQ® (U2) for treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The ODAC meeting aims to evaluate the benefit-risk profile of U2, especially in light of recent survival data from the UNITY-CLL trial. The FDA may not reach a decision by the PDUFA date of March 25, 2022, due to the anticipated timing of the ODAC meeting in March or April 2022.

TG Therapeutics (NASDAQ: TGTX) announced that its Executive Chairman and CEO, Michael S. Weiss, will host a fireside chat during the Jefferies London Healthcare Conference on November 18-19, 2021. The chat will be available for on-demand download starting at 8:00 AM GMT / 3:00 AM ET on November 18. Investors can access the discussion on the company's website for 30 days post-event. The company focuses on treatments for B-cell malignancies and autoimmune diseases, with ongoing Phase 3 programs for multiple sclerosis and chronic lymphocytic leukemia.

TG Therapeutics, Inc. (NASDAQ: TGTX) announced a fireside chat with CEO Michael S. Weiss scheduled for November 11, 2021, at 12:00 PM ET, during the B. Riley Securities’ Fall 2021 Growth Biotech Best Ideas Virtual Series. The event will be accessible via a live webcast on the company's website, with a replay available post-event. TG Therapeutics focuses on innovative treatments for B-cell malignancies and autoimmune diseases, including UKONIQ®, which has received accelerated FDA approval.