Tg Therapeutics Inc - TGTX STOCK NEWS

TG Therapeutics (TGTX) has voluntarily withdrawn its Biologics License Application for the combination of ublituximab and UKONIQ for treating chronic lymphocytic leukemia (CLL) after updated survival data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.

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.