Welcome to our dedicated page for Tg Therapeutics news (Ticker: TGTX), a resource for investors and traders seeking the latest updates and insights on Tg Therapeutics stock.
TG Therapeutics, Inc. (NASDAQ: TGTX) is a commercial-stage biopharmaceutical company focused on B-cell diseases, with news flow centered on its CD20-targeted monoclonal antibody BRIUMVI (ublituximab-xiiy) for relapsing forms of multiple sclerosis (RMS). This news page aggregates company announcements, clinical data updates, financial results, and corporate presentations related to TGTX stock.
Recent press releases highlight preliminary and reported revenue from BRIUMVI, including disclosures that product revenue consists primarily of net product sales of BRIUMVI in the United States and sales to ex-U.S. partners. Investors can follow updates on revenue guidance, operating expense targets, and commentary on how BRIUMVI commercialization influences overall company performance.
TG Therapeutics also issues frequent news about its development programs. These items include progress in the ENHANCE Phase 3b trial evaluating a simplified intravenous dosing schedule for BRIUMVI, the Phase 3 pivotal program for subcutaneous ublituximab, and the Phase 1 trial of azer-cel, an allogeneic CD19 CAR T therapy in autoimmune disease. Additional releases cover long-term ULTIMATE I & II trial data, real-world ENABLE observational study outcomes, and schedules of data presentations at neurology and multiple sclerosis congresses.
Corporate news includes participation in major healthcare and biotechnology investor conferences, rankings such as the Deloitte Technology Fast 500, and announcements of share repurchase authorizations. By following this TGTX news feed, readers can monitor how clinical results, regulatory milestones, commercialization updates, and financial disclosures intersect for TG Therapeutics and its lead therapy BRIUMVI.
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.
TG Therapeutics announced six abstracts for the 63rd ASH annual meeting, scheduled for December 11-14, 2021, in Atlanta, Georgia. Key presentations will include new data from the UNITY-NHL Phase 2b trial and two analyses from the UNITY-CLL Phase 3 trial, focusing on patients with comorbidities. The company emphasizes the potential of its U2 combination therapy for B-cell malignancies. Oral and poster presentations are detailed, showcasing the innovations in treating chronic lymphocytic leukemia and B-cell malignancies. More information is available on ASH's website.
TG Therapeutics, Inc. (TGTX) announced its third-quarter financial results for 2021, highlighting the submission of a Biologics License Application (BLA) for ublituximab to treat relapsing multiple sclerosis. The company reported product revenues of $4.3 million since UKONIQ's launch. R&D expenses rose to $52 million, driven by BLA submission costs, while SG&A expenses increased to $34.9 million. Despite a net loss of $85.6 million, TG Therapeutics maintains a robust cash position of $381.4 million, projected to fund operations into 2023. A conference call will be held today to discuss these results.