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

Core Viewpoint - Argenx SE's stock is experiencing a decline due to serious safety concerns raised by the FDA regarding its drug Vyvgart Hytrulo, particularly related to chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) [1][2] Group 1: FDA Concerns - The FDA has identified severe risks associated with Vyvgart Hytrulo, specifically the worsening of CIDP, which is characterized by inflammation of nerve roots and peripheral nerves [1] - The FDA is currently evaluating the need for potential regulatory action regarding Vyvgart [2] Group 2: Drug Approval and Usage - The European Commission has recently approved Vyvgart 1000mg for subcutaneous injection as a monotherapy for adult patients with progressive or relapsing active CIDP after prior treatments [2] - In April, the FDA approved a self-injection option for Vyvgart Hytrulo for adult patients with generalized myasthenia gravis (gMG) and CIDP [3] Group 3: Stock Performance and Analyst Ratings - Argenx's stock has an average 1-year price target of $753.23, indicating an expected upside of 43.52% [4][6] - There are no bearish recommendations for Argenx, with 13 analysts providing bullish ratings; the highest price target is $1065.0 from Guggenheim, while the lowest is $680.0 from Baird [5][7] - As of the latest check, Argenx's stock is down 6.56% at $523.37 [7]