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Monday, June 30, 2025

argenx down as FDA identifies possible safety signal with Vyvgart Hytrulo

 

  • argenx (NASDAQ:ARGX) is down ~7% in Monday trading after the U.S. FDA issued an alert on a potential signal of serious risks associated with Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase).
  • The agency says that the treatment, used for generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy, has a potential risk of "severe worsening of chronic inflammatory demyelinating polyradiculoneuropathy" based on reports to the FDA Adverse Event Reporting System.
  • The FDA noted it is evaluating the need for possible regulatory action. 

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