Bullish indicating open at $55-$60, IPO prices at $37
NEW YORK - TG Therapeutics, Inc. (NASDAQ: NASDAQ:TGTX) has presented data from its Phase 3 trials of BRIUMVI® (ublituximab-xiiy) for treating relapsing forms of multiple sclerosis (RMS) at the Americas Committee for Treatment and Research in Multiple Sclerosis forum in West Palm Beach, Florida. The data include findings from the ULTIMATE I & II and ENHANCE Phase 3b trials.
The ENHANCE trial data showed a consistent safety and tolerability profile in over 80 patients who received the maintenance BRIUMVI dose in 30 minutes. Additionally, an independent presentation by Dr. John Foley of the Rocky Mountain Multiple Sclerosis Center provided a retrospective review of over 160 individuals treated with BRIUMVI, supporting the safety and tolerability profile observed in the ULTIMATE trials.
ULTIMATE I & II were randomized, double-blind trials comparing BRIUMVI to teriflunomide, an oral medication, in patients with RMS over 96 weeks. The trials enrolled 1,094 patients across 10 countries. BRIUMVI, administered intravenously, targets CD20-expressing B-cells, a therapeutic approach for autoimmune disorders like RMS.
BRIUMVI is indicated for adult patients with various forms of RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Its unique design, lacking certain sugar molecules on the antibody, allows for efficient B-cell depletion at low doses.
The safety information accompanying BRIUMVI highlights potential risks, such as infusion reactions, infections, and reactivation of Hepatitis B Virus. No cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported in BRIUMVI-treated MS patients, although it has been observed with other anti-CD20 antibodies and MS therapies.
TG Therapeutics is focused on novel treatments for B-cell diseases and has received FDA approval for BRIUMVI as well as approval by the European Commission and the UK’s MHRA for treating RMS. The company’s revenue has grown by nearly 40% over the last twelve months, demonstrating strong market traction. InvestingPro subscribers can access 8 additional key insights about TG Therapeutics’ financial health and growth prospects, along with detailed analysis in the Pro Research Report.
This news is based on a press release statement from TG Therapeutics, Inc. and does not endorse any claims made. The effectiveness and safety of BRIUMVI will continue to be evaluated as more data become available. Investors should note that analysts maintain a bullish outlook on the stock, with the next earnings report scheduled for March 4, 2025. For comprehensive financial analysis and detailed metrics, including Fair Value estimates and growth projections, visit InvestingPro.
In other recent news, TG Therapeutics has reported strong preliminary financial results for the fourth quarter and full year of 2024, with U.S. net product revenue for Briumvi reaching $103.6 million for the quarter and $310 million for the year. These figures significantly exceeded the company’s own projections and consensus estimates. The company has set ambitious targets for 2025, projecting total global revenue of approximately $540 million, with Briumvi U.S. net product revenue expected to contribute around $525 million. TG Therapeutics also reported a robust cash position of approximately $310 million at the end of 2024.
H.C. Wainwright has reiterated its Buy rating for TG Therapeutics, maintaining a price target of $55, citing the company’s strong financial performance and growth potential. The company plans to expand Briumvi’s reach and has outlined a development pipeline for 2025, which includes pivotal trials for a subcutaneous version of Briumvi and other treatments. TG Therapeutics has also announced plans to initiate trials for autoimmune diseases beyond multiple sclerosis. These developments were shared during the 43rd Annual J.P. Morgan Healthcare Conference, reflecting the company’s strategic focus and financial health as it moves into 2025.
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