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Investing.com - argenx SE (NASDAQ:ARGX), a $33.8 billion biotech company with strong financial health according to InvestingPro metrics, saw its shares decline Monday after the company’s Vyvgart Hytrulo appeared in the FDA’s latest FAERS (FDA Adverse Event Reporting System) update.
The FDA is evaluating a potential signal for severe worsening of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) associated with the drug and is assessing whether regulatory action is needed, according to the update. Despite this news, the company maintains strong fundamentals with 82% revenue growth over the last twelve months.
Citi maintained its Buy rating and $803.00 price target on argenx despite the news, cautioning against over-interpreting the FAERS data, which the firm noted lacks important details such as causation, co-morbidities, and timing of safety events. This aligns with the broader Wall Street sentiment, as InvestingPro data shows a strong bullish consensus among analysts, with comprehensive research reports available for deeper analysis.
The investment bank highlighted that CIDP worsening is already a known safety event based on data from the ADHERE study, and that CIDP is heterogeneous, with not all patients having autoantibody-driven disease that would respond to Vyvgart Hytrulo.
argenx is currently conducting a Phase 4 switching study to better inform how to transition patients from IVIg to Vyvgart Hytrulo, which Citi believes will provide valuable information for physicians and patients.
In other recent news, Argenx SE has been the subject of multiple developments that are of interest to investors. The U.S. Food and Drug Administration (FDA) identified a potential serious risk associated with Argenx’s lead drug, Vyvgart, specifically a severe worsening of chronic inflammatory demyelinating polyradiculoneuropathy. This has prompted the FDA to evaluate whether regulatory action is necessary. On a more positive note, TD Cowen reiterated its Buy rating and a $761 price target for Argenx, following successful trial results for Vyvgart in treating myositis and Sjogren’s disease. H.C. Wainwright also maintained its Buy rating with a $720 price target, highlighting Vyvgart’s strong clinical data and potential benefits in treating myasthenia gravis. Meanwhile, JMP Securities slightly lowered its price target to $699 but kept an Outperform rating after Argenx’s first-quarter financial results exceeded expectations. Finally, Baird upgraded Argenx from Neutral to Outperform, keeping a $680 target, expressing confidence in Vyvgart’s long-term volume-driven growth despite recent stock price declines. These developments reflect a complex landscape for Argenx as it navigates regulatory challenges and capitalizes on promising clinical results.
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