TG Therapeutics, Inc. - TGTX STOCK NEWS

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.

TG Therapeutics (NASDAQ: TGTX) will hold a conference call on November 4, 2021, at 8:30 AM ET to discuss Q3 2021 results and provide a business outlook for the remainder of the year. The call will be hosted by Michael S. Weiss, Chairman and CEO. Participants can join by calling the provided numbers, with a live webcast available on the company's website. A financial results press release will precede the call.

TG Therapeutics, Inc. (TGTX) announced significant data from the Phase 3 ULTIMATE I & II trials at ECTRIMS 2021, showing that ublituximab treatment resulted in a statistically significant reduction in annualized relapse rate (ARR) compared to teriflunomide. Key findings include an ARR of 0.076 vs. 0.188 in ULTIMATE I and 0.091 vs. 0.178 in ULTIMATE II, representing reductions of approximately 60% and 50%, respectively. Ublituximab also demonstrated notable improvements in the Multiple Sclerosis Functional Composite (MSFC) score, with data supporting a Biologics License Application (BLA) to the FDA for treating relapsing forms of multiple sclerosis.

TG Therapeutics, Inc. (NASDAQ: TGTX) has submitted a Biologics License Application (BLA) to the FDA for its investigational drug, ublituximab, to treat relapsing forms of multiple sclerosis (RMS). This submission is based on the successful Phase 3 ULTIMATE I & II trials, which showed ublituximab significantly reduced the annualized relapse rate compared to teriflunomide. The trials enrolled 1,094 patients across 10 countries and were conducted under a Special Protocol Assessment with the FDA. This marks TG Therapeutics' first marketing application for an autoimmune indication.

TG Therapeutics (TGTX) announced that both ULTIMATE I & II Phase 3 trials of ublituximab met their primary endpoints, demonstrating a statistically significant reduction in annualized relapse rate (ARR) over 96 weeks (p<0.005). The findings will be presented at the ECTRIMS Congress on October 14, 2021. The trials involved 1,094 patients across 10 countries. Ublituximab, an investigational treatment, targets CD20+ B-cells and aims to improve outcomes for patients with relapsing multiple sclerosis (RMS). An investor event will discuss the trial data at 12:30 PM ET on the same day.