Bullish indicating open at $55-$60, IPO prices at $37
NEW YORK - TG Therapeutics, Inc. (NASDAQ:TGTX), a biopharmaceutical company with impressive gross profit margins of 88.3% and annual revenue of $329 million, has presented new data on its relapsing multiple sclerosis (RMS) treatment, BRIUMVI® (ublituximab-xiiy), at the American Academy of Neurology's annual meeting. The data, from the ENHANCE trial, showed that a single 600 mg dose of BRIUMVI was well tolerated by patients. According to InvestingPro analysis, the company's stock has delivered a remarkable 143.7% return over the past year, reflecting strong investor confidence in its product pipeline.
Michael S. Weiss, CEO and Chairman of TG Therapeutics, expressed optimism regarding the ENHANCE trial results. Weiss indicated the company's intention to initiate a registration-directed trial aiming to combine the approved Day 1 and Day 15 doses of BRIUMVI into a single dose for the future. With the company currently trading near its InvestingPro Fair Value and maintaining strong liquidity with a current ratio of 6.25, TG Therapeutics appears well-positioned to fund its ongoing research initiatives.
The ENHANCE trial focused on a modified regimen of Ublituximab, while additional data from a five-year study of Ublituximab in RMS was also shared, highlighting results from the open-label extension of the ULTIMATE I and II Studies.
ULTIMATE I & II were randomized, double-blind, active comparator-controlled clinical trials involving 1,094 patients with RMS across 10 countries. The trials compared the efficacy of BRIUMVI against teriflunomide, an oral medication. Patients in the BRIUMVI group received intravenous infusions at specified intervals along with oral placebo, while the comparator group received daily oral teriflunomide and IV placebo.
BRIUMVI is a monoclonal antibody designed to deplete B-cells, which are implicated in the pathology of autoimmune disorders like RMS. The product has been glycoengineered to improve its efficacy at lower doses. It is currently approved for the treatment of adults with various forms of RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
The safety profile of BRIUMVI includes warnings about infusion reactions, which occurred in 48% of treated patients who received premedication. Serious infections were reported in 5% of BRIUMVI-treated patients compared to 3% of those treated with teriflunomide.
TG Therapeutics is a biopharmaceutical company focused on novel treatments for B-cell diseases. BRIUMVI® has received FDA approval in the United States and approvals in Europe and the United Kingdom for the treatment of RMS. The company has achieved an "GREAT" Financial Health score from InvestingPro, which offers comprehensive analysis of over 1,400 US stocks through its Pro Research Reports, providing investors with detailed insights into companies like TG Therapeutics that are transforming the healthcare landscape.
The press release statement from TG Therapeutics provided the basis for this report.
In other recent news, TG Therapeutics reported its fourth-quarter financial results for 2024, revealing a GAAP earnings per share (EPS) of $0.15, which surpassed both the firm's and consensus estimates of $0.13. The company's total revenue for the quarter reached $108.2 million, contributing to a full-year revenue of $329.0 million, with product revenue primarily driven by Briumvi sales in the U.S. Additionally, H.C. Wainwright maintained its Buy rating for TG Therapeutics, setting a price target of $55, reflecting confidence in the company's financial performance and projections. Cantor Fitzgerald also reiterated an Overweight rating, noting strong market uptake for Briumvi, particularly in January and February, which saw the highest number of new patient enrollments since the drug's launch.
Recent presentations at the American Academy of Neurology's annual meeting highlighted Briumvi's favorable tolerability and consistent safety profile over five years of treatment. In parallel, TG Therapeutics shared findings from publications on the experiences of MS patients switching to Briumvi from other therapies, showing clinical improvements. Meanwhile, Roche's Phase III MUSETTE trial for a higher dose of Ocrevus did not meet its primary endpoint, reinforcing the current 600 mg dose's status as the standard care for relapsing multiple sclerosis.
TG Therapeutics continues to focus on developing innovative treatments for B-cell diseases and is optimistic about Briumvi's potential to improve outcomes for MS patients. The company ended 2024 with a cash position of approximately $311.0 million and aims to maintain strong cash flow into 2025. These developments underscore TG Therapeutics' ongoing commitment to addressing the needs of the MS community through research and development.
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