Tg Therapeutics Inc - TGTX STOCK NEWS

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.

TG Therapeutics announced the publication of safety results for UKONIQ^® (umbralisib) in patients with relapsed lymphoid malignancies. The study, published in Blood Advances, included data from 371 patients, highlighting a low discontinuation rate due to adverse events, suggesting a favorable safety profile. UKONIQ is the first dual inhibitor of PI3K-delta and CK1-epsilon, now available for treating marginal zone and follicular lymphoma. The company aims for FDA approval of a combination treatment with ublituximab by March 25, 2022.

TG Therapeutics to Participate in Healthcare Conference

TG Therapeutics (NASDAQ: TGTX) announced that CEO Michael S. Weiss will join a fireside chat at the 2021 Cantor Virtual Healthcare Conference on September 27, 2021, at 10:40 AM ET. The conference runs from September 27 to 30, 2021. A live webcast will be available on the company's Events page, with a replay following the event. TG Therapeutics focuses on innovative treatments for B-cell malignancies and autoimmune diseases and has received FDA accelerated approval for UKONIQ®.

TG Therapeutics (NASDAQ: TGTX) announced a virtual event on September 20, 2021, at 8:30 AM ET to discuss updated data from their Phase 1 trial of U2 (umbralisib and ublituximab) combined with venetoclax for treating chronic lymphocytic leukemia (CLL). Highlights from the XIX International Workshop on Chronic Lymphocytic Leukemia were shared, demonstrating significant improvements in progression-free survival (PFS) and overall response rates (ORR) in these combinations. A PDUFA date for potential U2 regimen approval is set for March 25, 2022.

TG Therapeutics is set to host a virtual investor and analyst event on September 20, 2021, at 8:30 AM ET to discuss updated Phase 1 data for the combination of UKONIQ® (umbralisib) and ublituximab (U2) with venetoclax. This follows significant findings presented at the XIX International Workshop on Chronic Lymphocytic Leukemia with a reported 100% overall response rate among 46 patients with relapsed or refractory CLL. The event will also cover the ULTRA-V Phase 2/3 trial, highlighting the promising efficacy of the investigational treatment.