NEW YORK - TG Therapeutics, Inc. (NASDAQ:TGTX) disclosed findings from the ULTIMATE I & II Phase 3 trials of BRIUMVI® (ublituximab-xiiy) for relapsing forms of multiple sclerosis (RMS) at the American Academy of Neurology's annual event in Denver, Colorado. The data presented on Sunday compared BRIUMVI to teriflunomide, an oral medication, showing BRIUMVI's robust clinical activity in RMS treatment.
The trials involved 1,094 RMS patients from 10 countries, randomized to receive either BRIUMVI or teriflunomide over 96 weeks. BRIUMVI, administered intravenously, is designed for efficient B-cell depletion at low doses due to its unique glycoengineering process.
Michael S. Weiss, CEO and Chairman of TG Therapeutics, expressed optimism about BRIUMVI's role as a valuable treatment for RMS, citing post-hoc analyses that offer new insights. Two additional presentations are scheduled for Wednesday, April 17, 2024, focusing on BRIUMVI's impact on radiological disease activity and disability outcomes, particularly in treatment-naive patients.
BRIUMVI is indicated for adult RMS patients, including those with clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It targets CD20-expressing B-cells, a method proven effective for managing autoimmune disorders.
The product's safety profile includes potential risks such as infusion reactions and infections, with a 48% incidence of infusion reactions in trial participants who received premedication. Serious infections occurred in 5% of BRIUMVI-treated patients versus 3% for teriflunomide.
The press release also highlights BRIUMVI's contraindications, including active Hepatitis B infection and a history of severe infusion reactions to the drug. It outlines precautions for infusion reactions, infections, HBV reactivation, and the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection.
TG Therapeutics provides BRIUMVI Patient Support to assist U.S. patients with their treatment journey. The company, focused on novel treatments for B-cell diseases, has received FDA approval for BRIUMVI and approval in Europe and the UK for treating adult RMS patients with active disease.
This article is based on a press release statement from TG Therapeutics, Inc.
InvestingPro Insights
Amid the promising clinical outcomes for BRIUMVI, TG Therapeutics, Inc. (NASDAQ:TGTX) has drawn attention not just for its potential in treating relapsing forms of multiple sclerosis but also for its financial metrics and market performance. According to real-time data from InvestingPro, the company has a market capitalization of $2.05 billion, reflecting its significant presence in the biopharmaceutical sector.
Investors are closely monitoring TGTX's stock, which is currently trading at a high earnings multiple with a P/E ratio of 157.19, suggesting strong investor confidence in the company's future earnings potential. The adjusted P/E ratio for the last twelve months as of Q4 2023 stands at 161.78, indicating expectations of continued growth. This is further supported by a staggering revenue growth of 8290.02% for the same period, highlighting the company's rapid expansion and its ability to generate sales.
Two InvestingPro Tips that stand out for TG Therapeutics are the impressive gross profit margins and the fact that two analysts have revised their earnings upwards for the upcoming period. The gross profit margin for the last twelve months as of Q4 2023 was an exceptional 93.95%, showcasing the company's efficiency in managing its cost of goods sold and maintaining profitability. Additionally, the upward earnings revisions by analysts may signal a positive outlook on the company's financial health and its prospects moving forward.
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