NEW YORK - TG Therapeutics, Inc. (NASDAQ: NASDAQ:TGTX) has released updated data from its ENHANCE Phase 3b trial concerning BRIUMVI (ublituximab-xiiy), a treatment for relapsing forms of multiple sclerosis (RMS). The findings, presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, indicate that BRIUMVI infusions can be administered safely and effectively.
The ENHANCE study assessed optimized dosing regimens for BRIUMVI, particularly focusing on the transition from prior anti-CD20 therapy in B-cell depleted patients. The company's Chairman and CEO, Michael S. Weiss, expressed optimism about the potential for BRIUMVI to offer a convenient and safe treatment option without the need for an initial 4-hour infusion.
Weiss also highlighted new data on the feasibility of administering 450 mg BRIUMVI infusions in just 30 minutes starting at week 24, which were completed without interruption or slowing. Importantly, infusion-related reactions (IRRs) were all mild and fully resolved.
The ENHANCE trial is an open-label, 48-week study in RMS patients, designed to evaluate the safety of eliminating the initial 150 mg BRIUMVI infusion and to explore shorter durations for subsequent full infusions. The study reported a 97% success rate for 1-hour infusions without interruption or slowing.
BRIUMVI, a novel monoclonal antibody targeting CD20-expressing B-cells, is indicated for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The antibody's design, which omits certain sugar molecules, allows for efficient B-cell depletion at low doses.
The safety and efficacy of BRIUMVI were also evaluated in the ULTIMATE I & II Phase 3 trials, which compared BRIUMVI to teriflunomide, an oral disease-modifying therapy. These trials enrolled 1,094 RMS patients across 10 countries and were led by Dr. Lawrence Steinman of Stanford University.
As with any treatment, BRIUMVI comes with important safety information, including contraindications for patients with active Hepatitis B Virus infection or a history of life-threatening infusion reactions to the drug. The most common adverse reactions reported in clinical trials were infusion reactions and upper respiratory tract infections.
The company remains committed to improving patient tolerability and convenience and is working with regulatory agencies to potentially incorporate these findings into future labeling. This update is based on a press release statement from TG Therapeutics, Inc.
In other recent news, TG Therapeutics has made significant strides in the biotech sector. The company's flagship drug, BRIUMVI, showed sustained efficacy in a 5-year Multiple Sclerosis trial, with a significant reduction in relapse frequency. This data was revealed at the European Committee for Treatment and Research in Multiple Sclerosis annual meeting.
On the financial front, TG Therapeutics reported net sales of BRIUMVI reaching $72.6 million in the second quarter, leading to an increase in its full-year revenue guidance to between $290 million and $300 million. This financial performance was a factor in JPMorgan (NYSE:JPM)'s decision to increase the price target for TG Therapeutics shares, highlighting the company's solid fundamentals.
Additionally, the company has implemented a share repurchase program, which is seen as enhancing its appeal as a biotech investment. These recent developments underscore TG Therapeutics' potential for sustained growth and profitability in the biotech sector. 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.
InvestingPro Insights
TG Therapeutics, Inc. (NASDAQ: TGTX) has been making notable strides not only in clinical advancements but also in its financial metrics and market performance. According to InvestingPro data, the company boasts an impressive gross profit margin of 92.76% for the last twelve months as of Q2 2024, underscoring the efficiency of its operations and the potential profitability of its treatments like BRIUMVI. This aligns with the positive outlook shared by the company's Chairman and CEO, Michael S. Weiss, on the treatment's market potential.
Investors have taken note of the company's performance, with the stock achieving a significant return of 163.72% over the last year and trading near its 52-week high at 96.35% of the peak price. The company's market capitalization stands at $3.6 billion, reflecting the market's confidence in its growth trajectory. Additionally, the InvestingPro Tips highlight that TGTX is trading at a low Price/Earnings to Growth (PEG) ratio of 0.25, suggesting that the stock could be undervalued relative to its earnings growth potential.
For those looking to delve deeper into TG Therapeutics' financial health and future prospects, InvestingPro offers a wealth of additional insights. Currently, there are 19 more InvestingPro Tips available, including analyses on earnings revisions, valuation multiples, and liquidity metrics, which can provide investors with a comprehensive understanding of the company's investment potential.
As TGTX continues to make headway in the treatment of RMS, these financial indicators and expert insights from InvestingPro could be invaluable for investors considering the stock. For further details and tips, interested parties can visit InvestingPro's dedicated TGTX page at https://www.investing.com/pro/TGTX.
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