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 develops and commercializes therapies for B-cell diseases, with news centered on BRIUMVI (ublituximab-xiiy), its anti-CD20 monoclonal antibody for adult patients with relapsing forms of multiple sclerosis. Company updates commonly cover U.S. net product revenue, global revenue targets, commercial demand, and international commercialization economics tied to BRIUMVI.
Recurring developments also include clinical and real-world data for BRIUMVI in relapsing multiple sclerosis, presentations and publications from multiple sclerosis studies, and development work on a subcutaneous formulation. Corporate news includes financing arrangements, share repurchase authorization updates, operating-expense guidance, and business outlook commentary alongside quarterly and annual results.
TG Therapeutics (TGTX) announced data presentations from the ULTIMATE I and II Phase 3 trials for ublituximab, targeting relapsing forms of multiple sclerosis (RMS), to be showcased at the AAN annual meeting from April 2-7, 2022. Highlights include an oral presentation on reduced relapse rates compared to teriflunomide, alongside three poster presentations focused on disability improvements, disease activity, and infusion-related reactions. The trials involved 1,094 patients across 10 countries, demonstrating statistically significant results supporting ublituximab's potential approval.
TG Therapeutics (NASDAQ: TGTX) announced that the FDA has extended the PDUFA goal date to June 25, 2022, for the BLA and sNDA for ublituximab in combination with UKONIQ (umbralisib) for treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The extension allows the FDA to conduct a thorough review of updated overall survival data submitted in February 2022, which the agency classified as a major amendment. The ongoing review follows an early analysis from the UNITY-CLL trial.
TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for Q4 and full-year 2021, highlighting a net loss of $93.3 million for Q4 and $348.1 million for the year. Product revenue reached $2.3 million for Q4 and $6.5 million for the year from UKONIQ. The company remains optimistic about 2022, with pending FDA submissions for ublituximab and UKONIQ in treating multiple sclerosis and chronic lymphocytic leukemia. Cash reserves stand at $350.3 million, expected to fund operations into 2023.
TG Therapeutics, Inc. (NASDAQ: TGTX) presented new data from the Phase 3 ULTIMATE I & II trials at the ACTRIMS annual forum, showcasing the potential of ublituximab in treating relapsing forms of multiple sclerosis (RMS). Highlights include significant reductions in hypointense lesions and favorable safety profiles. Ublituximab demonstrated a 4.9x lower volume and a 3.6x fewer number of lesions compared to teriflunomide. The company anticipates an FDA decision on ublituximab by September 28, 2022. These findings may impact the treatment landscape for RMS.
TG Therapeutics (NASDAQ: TGTX) will host a conference call on March 1, 2022, at 8:30 AM ET to discuss its fourth quarter and year-end 2021 results. CEO Michael S. Weiss will lead the call, which will also provide insights into the business outlook for 2022. The financial results will be published in a press release prior to the call. TG Therapeutics focuses on developing treatments for B-cell malignancies and autoimmune diseases, with several programs in advanced clinical stages, including the FDA-approved UKONIQ® for specific lymphomas.
TG Therapeutics, Inc. (NASDAQ: TGTX) announced data presentations from the ULTIMATE I & II Phase 3 trials of ublituximab for relapsing multiple sclerosis (RMS) at the ACTRIMS forum on February 24-26, 2022. Three abstracts will detail encouraging analyses reinforcing ublituximab's potential as a treatment option. Both trials met their primary endpoint, showing a significant reduction in annualized relapse rate compared to teriflunomide (p0.005). The trials enrolled 1,094 patients across 10 countries, conducted under FDA agreement.
TG Therapeutics has announced that Michael S. Weiss, the Company’s Chairman and CEO, will participate in a fireside chat at the B. Riley Securities’ 2022 Virtual Oncology Investor Conference on January 27, 2022, at 10:00 AM ET. A live webcast of the event will be available on the Company’s website, with a replay accessible afterward. TG Therapeutics is focused on developing treatments for B-cell malignancies and autoimmune diseases, with several investigational medicines and FDA accelerated approvals, including UKONIQ for certain lymphoma treatments.
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.