FDA Flags Major Safety Concerns For Argenx's Nerve Disorder Drug, Stock Falls

Argenx SE (NASDAQ:ARGX) stock is trading lower on Monday after the U.S. Food and Drug Administration (FDA) signaled serious risks/safety identified by the reporting system for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase).

The FDA highlighted the severe worsening of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). CIDP is an immune-mediated polyneuropathy marked by nerve roots and peripheral nerve inflammation.

The FDA noted it is evaluating the need for possible regulatory action. Most recently, the European Commission approved Vyvgart 1000mg for subcutaneous (SC) injection as a monotherapy for adult patients with progressive or relapsing active CIDP after prior treatment with corticosteroids or immunoglobulins.

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