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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In April, the FDA approved a new option for patients to self-inject Argenx’s Vyvgart Hytrulo with a prefilled syringe for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and adult patients with CIDP.

In April, Argenx showcased long-term data of Vyvgart demonstrating sustained disease control of gMG and CIDP with a favorable safety profile.

Understanding Argenx’s Stock

Equity research can be a valuable source of information for learning about a company’s fundamentals. Analysts create financial models based on the fundamentals and expected future earnings of a company to arrive at a price target and recommendation for the stock.

Shares of Argenx have an average 1-year price target of $753.23, representing an expected upside of 43.52%.

Because of differences in assumptions, analysts can arrive at very different price targets and recommendations. No analysts have bearish recommendations on Argenx, while 13 analysts have bullish ratings. The street high price target from Guggenheim is $1065.0, while the street low from Baird is $680.0.

Equity research can be a valuable source of information for learning about a company’s fundamentals. Analysts create financial models based on the fundamentals and expected future earnings of a company to arrive at a price target and recommendation for the stock.

Shares of Argenx have an average 1-year price target of $753.23, representing an expected upside of 43.52%.

Because of differences in assumptions, analysts can arrive at very different price targets and recommendations. No analysts have bearish recommendations on Argenx, while 13 analysts have bullish ratings. The street high price target from Guggenheim is $1065.0, while the street low from Baird is $680.0.

Price Action: ARGX stock is down 6.56% at $523.37 at the last check on Monday.

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