NEW YORK - TG Therapeutics, Inc. (NASDAQ:TGTX) revealed new data from its ULTIMATE I & II Phase 3 trials at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting. The trials evaluated BRIUMVI (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS) over five years. The presentations highlighted the long-term efficacy and safety of BRIUMVI, with the annualized relapse rate (ARR) decreasing to 0.020 in the fifth year, indicating a significant reduction in relapse frequency.
The data showed that RMS patients who continued BRIUMVI treatment experienced low and declining ARR throughout the five-year observation period. In contrast, patients who initially received teriflunomide and then switched to BRIUMVI also saw a reduction in ARR but had a higher rate of confirmed disability progression (CDP) compared to those who were on continuous BRIUMVI treatment.
Only 8% of patients on BRIUMVI for five years had CDP lasting 24 weeks, compared to 14.3% of patients who switched from teriflunomide to BRIUMVI. Additionally, 17% of continuous BRIUMVI patients achieved confirmed disability improvement (CDI) lasting at least 24 weeks.
The safety profile of BRIUMVI remained consistent over the five years, with no new safety signals emerging. Immunoglobulin levels also remained stable, and there was no association found between decreased immunoglobulin levels and the risk of serious infections.
The ULTIMATE I & II trials, led by Lawrence Steinman, MD, of Stanford University, were designed to compare the efficacy and safety of BRIUMVI against teriflunomide in patients with RMS. BRIUMVI is a novel monoclonal antibody that targets CD20-expressing B-cells and is indicated for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
TG Therapeutics believes that these long-term data continue to support BRIUMVI's role as a valuable treatment option for patients with RMS. The company's Chairman and CEO, Michael S. Weiss, expressed satisfaction with the sustained clinical benefits observed in patients treated with BRIUMVI.
The presentations at ECTRIMS and additional information on the ULTIMATE I & II Phase 3 trials can be found on TG Therapeutics' website. This article is based on a press release statement from TG Therapeutics, Inc.
In other recent news, TG Therapeutics has made significant strides, with JPMorgan increasing the price target for its shares based on strong fundamentals. This follows the company's second-quarter results, which showed a solid performance with net sales of their flagship drug Briumvi reaching $72.6 million. This success has led TG Therapeutics to raise its full-year revenue guidance to between $290 million and $300 million.
JPMorgan analysts have highlighted the company's Veterans Affairs contract as a positive influence for the second half of 2024, potentially leading to demand that exceeds the revised guidance. The firm also noted the company's implementation of a share repurchase program, enhancing its appeal as a biotech investment.
These recent developments underscore the company's strategic focus on Briumvi and its market performance. The company expects modest growth from Q2 to Q3, with stronger growth from Q3 to Q4, and remains confident in maintaining profitability and positive cash flow. These actions, combined with strategic financial maneuvers, are seen as strong indicators of TG Therapeutics' potential for sustained growth and profitability in the biotech sector.
InvestingPro Insights
TG Therapeutics, Inc. (NASDAQ:TGTX) has recently showcased promising long-term data for their RMS treatment, BRIUMVI, which could be a game-changer for patients and the company's financial performance alike. As investors assess TGTX's potential, considering its market presence and financial metrics is crucial. With a market capitalization of $3.6 billion, TGTX demonstrates substantial investor confidence. The company's impressive gross profit margin of 92.76% over the last twelve months as of Q2 2024 indicates efficient operations and strong pricing power.
Investors might also find TGTX's valuation metrics of particular interest. The P/E ratio stands at 37.68, which may seem high, but it is trading at a low P/E ratio relative to its near-term earnings growth, with a PEG ratio of just 0.25 over the same period. This suggests that the company's earnings growth could justify its current earnings multiple. Additionally, TGTX's stock price movements have been quite volatile, with a significant return of 163.72% over the last year, indicating strong investor enthusiasm and market momentum.
For those looking to delve deeper into TG Therapeutics' financial outlook, InvestingPro offers a wealth of additional insights. Currently, there are 19 more InvestingPro Tips available, which provide a comprehensive analysis of the company's financial health and market performance. These insights can be particularly valuable for investors considering TGTX as part of their portfolio. For a more informed investment decision, visit InvestingPro for further details.
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