- 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.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.