Bullish indicating open at $55-$60, IPO prices at $37
NEW YORK - TG Therapeutics, Inc. (NASDAQ:TGTX), a biopharmaceutical company with a market capitalization of $5.4 billion and impressive gross profit margins of 88.3%, has presented new data on its multiple sclerosis (MS) treatment, BRIUMVI® (ublituximab-xiiy), at the American Academy of Neurology's annual meeting. The presentations focused on BRIUMVI's use in relapsing forms of MS (RMS) and included findings from the ENAMOR survey and ENABLE Phase 4 study. According to InvestingPro data, the company's strong financial health and 40.8% revenue growth reflect its successful commercialization strategy.
The ENAMOR survey, which collected data from around 400 patients at 21 MS centers, indicated a favorable tolerability profile for BRIUMVI, with a lower rate of infusion-related reactions at the first dose compared to what was observed in the ULTIMATE Phase 3 trials. Notably, about 90% of patients in the survey were pre-medicated with acetaminophen, unlike in the ULTIMATE trials, which could explain the reduced reaction rates.
The ENABLE study, an observational study of approximately 500 patients across roughly 100 MS centers in the United States, aims to assess BRIUMVI's efficacy and tolerability in a real-world setting over a 96-week period.
Additionally, long-term data presented by Dr. Lawrence Steinman from Stanford University showed that after five years of treatment with BRIUMVI, the frequency of serious infections remained consistent with the Phase 3 trials, and no cases of progressive multifocal leukoencephalopathy (PML) were observed.
BRIUMVI, a monoclonal antibody targeting CD20-expressing B-cells, is designed for efficient B-cell depletion at low doses due to its unique glycoengineered structure. It is approved for adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Despite the promising data, the company cautions that the safety and efficacy profile of BRIUMVI could change as more data become available and that individual experiences in the post-marketing setting may vary. The company's focus remains on acquiring, developing, and commercializing novel treatments for B-cell diseases.
The information presented in this article is based on a press release statement from TG Therapeutics, Inc.
In other recent news, TG Therapeutics reported fourth-quarter earnings that exceeded analyst expectations, with a GAAP earnings per share (EPS) of $0.15 and non-GAAP EPS of $0.22, surpassing consensus estimates. The company achieved total revenue of $108.2 million for the quarter, contributing to a full-year revenue of $329.0 million in 2024, largely driven by U.S. sales of BRIUMVI®. H.C. Wainwright reaffirmed its Buy rating and set a $55 price target for TG Therapeutics, citing strong financial performance and future revenue projections. Cantor Fitzgerald also maintained an Overweight rating, noting strong market uptake for BRIUMVI® and potential upside for 2025 revenue guidance.
TG Therapeutics highlighted recent publications on BRIUMVI®, showcasing clinical improvements in MS patients switching from other anti-CD20 therapies. These findings align with ongoing ULTIMATE I & II Phase 3 trials comparing BRIUMVI® with teriflunomide. Meanwhile, Roche announced that its Phase III MUSETTE trial for a higher dose of Ocrevus did not meet its primary endpoint, affirming the efficacy of the existing 600 mg dose for RMS patients. Despite this, Ocrevus continues to be a leading treatment in MS care.
TG Therapeutics ended 2024 with a solid cash position of $311.0 million, reinforcing its capability to advance its pipeline and strategic initiatives. The company aims for approximately $540 million in total revenue for 2025, with significant contributions expected from BRIUMVI®. The recent developments indicate a strong commercial trajectory for TG Therapeutics, supported by robust financials and strategic partnerships.
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