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Investing.com -- Argenx NV ADR (NASDAQ:ARGX) stock tumbled 6% after the U.S. Food and Drug Administration (FDA) identified a potential serious risk associated with the company’s lead drug, Vyvgart.
The FDA published a report highlighting a "severe worsening of chronic inflammatory demyelinating polyradiculoneuropathy" as a potential signal of serious risk with Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) injection. The regulatory agency stated it is currently evaluating the need for regulatory action.
Vyvgart is Argenx’s flagship product, approved for treating generalized myasthenia gravis, a rare autoimmune disease. The identification of this safety concern comes at a critical time for the company, which has been positioning the medication as a key growth driver.
The FDA regularly monitors approved drugs for potential safety issues that weren’t identified during clinical trials. When a potential signal is detected, the agency conducts further investigation to determine whether regulatory action is warranted, which could range from label updates to more significant restrictions.
Investors reacted to the news by selling shares, reflecting concerns about potential impacts on Vyvgart’s commercial prospects should the FDA determine that additional warnings or limitations are necessary.
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