TG Therapeutics, Inc. - TGTX STOCK NEWS

TG Therapeutics, Inc. (NASDAQ: TGTX) announced an extension of the FDA's Prescription Drug User Fee Act (PDUFA) goal date to December 28, 2022 for its Biologics License Application (BLA) for ublituximab, aimed at treating relapsing forms of multiple sclerosis (RMS). This extension follows the FDA's request for additional clinical information deemed a major amendment. Despite the delay, CEO Michael S. Weiss expressed confidence that the extension would not hinder the company’s launch plans for ublituximab, which showed promising results in the Phase 3 ULTIMATE I & II trials.

TG Therapeutics (NASDAQ: TGTX) announced data presentations from the ULTIMATE I & II Phase 3 trials assessing ublituximab for relapsing forms of multiple sclerosis (RMS) at the CMSC annual meeting, June 1-4, 2022. The presentations include an oral discussion on reduced disease progression compared to teriflunomide. The ULTIMATE trials enrolled 1,094 patients across 10 countries and achieved a statistically significant reduction in the annualized relapse rate (ARR) over 96 weeks (p<0.005). Ublituximab is an investigational monoclonal antibody targeting CD20-expressing B-cells.

TG Therapeutics announced that CEO Michael S. Weiss will present at the H.C. Wainwright Global Investment Conference next week. The presentation will be available for on-demand viewing from May 24, 2022, at 7:00 AM ET through May 26, 2022. The webcast can be accessed on both the conference and TG Therapeutics website. The company focuses on innovative therapies for B-cell diseases, with a notable investigational drug, ublituximab, for treating relapsing forms of multiple sclerosis.

TG Therapeutics announced that Michael S. Weiss, the Company’s Chairman and CEO, will participate in a fireside chat at the B. Riley Securities’ 2022 Virtual Neuro & Ophthalmology Conference on April 28, 2022, at 12:30 PM ET. A live webcast will be available on their Investors & Media section, and a replay will follow the event. TG Therapeutics focuses on developing treatments for B-cell diseases, including ublituximab, an investigational monoclonal antibody for relapsing forms of multiple sclerosis.

TG Therapeutics (TGTX) has voluntarily withdrawn its Biologics License Application for the combination of ublituximab and UKONIQ for treating chronic lymphocytic leukemia (CLL) after updated survival data showed an imbalance in favor of the control arm. Consequently, the company also withdrew UKONIQ from sale for approved indications in marginal zone lymphoma (MZL) and follicular lymphoma (FL). CEO Michael S. Weiss expressed disappointment but emphasized a focus shift to their multiple sclerosis and autoimmune platform, with a pending BLA for ublituximab aimed at patients with relapsing forms of multiple sclerosis.

TG Therapeutics (TGTX) announced promising results from the Phase 3 ULTIMATE I & II trials for ublituximab in treating relapsing multiple sclerosis (RMS). The trials demonstrated a significant reduction in both the annualized relapse rate (ARR) and the time to first confirmed relapse compared to teriflunomide. Approximately 1,094 patients participated across 10 countries, and the findings were presented at the American Academy of Neurology meeting. The company aims for a Biologics License Application (BLA) submission, with a PDUFA goal date of September 28, 2022.

TG Therapeutics (NASDAQ: TGTX) announced promising results from the ULTIMATE I & II Phase 3 trials of ublituximab for treating relapsing multiple sclerosis (RMS), presented at the AAN annual meeting. Key findings include that 95.4% of patients showing 12-week confirmed disability improvement maintained progress by week 96. Ublituximab also demonstrated superior efficacy in achieving no evidence of disease activity (NEDA) compared to teriflunomide, with NEDA-3 rates of 44.6% vs. 12.4%. The treatment was well-tolerated, with 96.6% of patients completing infusions successfully.

TG Therapeutics, Inc. (NASDAQ: TGTX) announced that the FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting for April 22, 2022, regarding the Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for their drug combination of ublituximab and UKONIQ (U2) aimed at treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The FDA extended the PDUFA goal date to June 25, 2022 following concerns related to overall survival data from the UNITY-CLL trial. This meeting is critical for evaluating the benefit-risk profile of U2.

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.