TG Therapeutics, Inc. - TGTX STOCK NEWS

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 (p<0.005). 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.

TG Therapeutics (NASDAQ: TGTX) announced the acceptance of its Biologics License Application (BLA) for ublituximab, a monoclonal antibody targeting CD20, by the FDA as a treatment for relapsing forms of multiple sclerosis (RMS). The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of September 28, 2022, for its review. The application is based on successful results from the ULTIMATE I & II Phase 3 trials, which demonstrated significant efficacy over teriflunomide. This marks TG Therapeutics' first marketing application for an autoimmune indication.