Biopharmaceutical company TG Therapeutics Inc. (TGTX:NASDAQ), which focuses on developing and commercializing new treatments for B-cell malignancies and autoimmune diseases, today announced "positive topline results from two global, active-controlled, Phase 3 studies, called ULTIMATE I & II, evaluating ublituximab, the company's investigational novel, glycoengineered anti-CD20 monoclonal antibody, compared to teriflunomide in patients with relapsing forms of multiple sclerosis (RMS)."
The company stated that the ULTIMATE I & II trials enrolled 1,094 patients with RMS in 10 countries. The firm advised that in each of the studies ublituximab met the predetermined primary endpoint of significantly reducing annualized relapse rate (ARR) over a 96-week period. TG Therapeutics noted specifically that relative reductions in ARR of approximately 60% were observed in the ULTIMATE I study and 50% ARR reductions were recorded in the ULTIMATE II trial, when both were compared to teriflunomide. The firm did not report data pertaining to the secondary endpoints in the studies, which included "total number of T1 gadolinium-enhancing lesions, total number of new and/or enlarging T2 hyperintense lesions, and time to confirmed disability progression (CDP)."
The company advised that it plans to compile and present a detailed data presentation in H1/21 and is targeting to submit a Biologics License Application (BLA) submission for ublituximab in RMS in midyear 2021 to the U.S. Food and Drug Administration (FDA).
"B-cell targeted therapy with anti-CD20 monoclonal antibodies has dramatically shifted the treatment paradigm for patients with MS and has shown to be very effective in reducing relapses in patients. I am pleased to see such positive results from this important trial exploring a one-hour infusion of ublituximab every six months and believe, if approved, the unique attributes of ublituximab, particularly that it has been glycoengineered for enhanced antibody dependent cellular cytotoxicity, may offer benefits to patients in the RMS treatment paradigm," stated Lawrence Steinman, M.D., Zimmermann Professor of Neurology & Neurological Sciences and Pediatrics at Stanford University and Global Study Chair for the ULTIMATE I & II studies.
TG Therapeutics Chairman and CEO Michael S. Weiss remarked, "We are so pleased to share these positive topline results for our ULTIMATE MS studies. If approved, ublituximab has the potential to offer patients a one-hour infusion, which we believe will be an attractive option for many patients with MS. With more than 1,000,000 Americans estimated to be living with MS today, there continues to be a need for efficacious and convenient treatment options."
The company explained that RMS is a chronic demyelinating disease of the central nervous system. There are also other variations including relapsing-remitting multiple sclerosis (RRMS) and secondary progressive multiple sclerosis (SPMS). The firm noted that "RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery." The company listed that about 1 million individuals in the U.S. and that greater than 2.3 million people worldwide have a MS diagnosis.
TG Therapeutics is a biopharmaceutical company headquartered in New York City that specializes in the development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. The firm's current leading drug candidates targeting hematological malignancies and autoimmune diseases. The company described its ublituximab (TG-1101) as "a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes."
TG Therapeutics began the day with a market cap of around $3.9 billion with approximately 131.5 million shares outstanding and a short interest of about 10.3%. TGTX shares opened nearly 12% higher today at $33.10 (+$3.48, +11.75%) over yesterday's $29.62 closing price and reached a new 52-week high price this morning of $42.00. The stock has traded today between $32.88 and $42.00 per share and is currently trading at $41.76 (+$12.14, +40.99%).[NLINSERT]
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