NEW YORK - TG Therapeutics, Inc. (NASDAQ: NASDAQ:TGTX), a biopharmaceutical company, is scheduled to present data from multiple Phase 3 trials of its drug BRIUMVI® (ublituximab-xiiy) at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) forum. The event will take place from February 29 to March 2, 2024, in West Palm Beach, Florida.
The data presentations will focus on the ULTIMATE I & II and ENHANCE Phase 3 trials, which examine the efficacy of BRIUMVI in patients with relapsing forms of multiple sclerosis (RMS). The abstracts for the presentations are currently available on the ACTRIMS meeting website.
One poster presentation, set for Thursday, February 29, will redefine the concept of MS relapse by addressing the radiological and pseudoexacerbation paradox with BRIUMVI therapy. Another will evaluate the maintenance of efficacy and tolerability when transitioning from IV Anti-CD20 therapy to Ublituximab, showcasing interim data from the ENHANCE study.
ULTIMATE I & II are randomized, double-blind trials comparing BRIUMVI to teriflunomide, an active comparator, over a 96-week treatment period. The trials enrolled a total of 1,094 patients with RMS across 10 countries. BRIUMVI is an intravenous infusion designed for efficient B-cell depletion at low doses, targeting CD20-expressing B-cells, which are an important approach for managing autoimmune disorders such as RMS.
The presentations aim to shed light on BRIUMVI's potential benefits for RMS patients, with the drug already approved by the U.S. Food and Drug Administration (FDA) for adults with RMS. The drug's safety profile includes warnings about infusion reactions, infections, and the risk of hepatitis B virus reactivation, among other precautions.
TG Therapeutics is committed to supporting patients through their treatment journey with BRIUMVI Patient Support, a program designed to assist U.S. patients.
The information for this article is based on a press release statement from TG Therapeutics, Inc.
InvestingPro Insights
As TG Therapeutics, Inc. (NASDAQ: TGTX) gears up to present key data at the ACTRIMS forum, investors and stakeholders are closely monitoring the company's financial health and market performance. With a market capitalization of approximately $1.96 billion, TGTX reflects a significant presence in the biopharmaceutical sector. Despite a negative P/E ratio of -74.99, which indicates that the company is not currently profitable, the revenue growth figures are staggering. The last twelve months as of Q3 2023 saw a revenue growth of 3675.79%, a testament to the potential market impact and adoption of its drug BRIUMVI®.
The company's gross profit margin stands at a robust 96.69% for the same period, indicating that the cost of goods sold is a small fraction of the sales revenue, which is an encouraging sign for operational efficiency. However, the operating income margin is negative at -9.98%, reflecting operational costs that exceed the gross profit.
Investors are also watching the stock's performance, with a 6-month price total return of 33.62%, which may suggest growing investor confidence in the company's long-term prospects. The fair value estimates provide a mixed picture; while analyst targets suggest a fair value of $34, InvestingPro's own fair value assessment is at $12.28, which may warrant further investigation by prospective investors.
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