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0.000559910414333794 0.00111982082866759 0.00391937290033596 0.00503919372900335 -0.00111982082866739 -0.00279955207166837 0.00279955207166857 0.00783874580067192
Stock impact report

FDA Expands argenx's (ARGX) Vyvgart Label to Treat Rare Disorder [Yahoo! Finance]

Arcutis Biotherapeutics, Inc. - Common stock (ARQT) 
Company Research Source: Yahoo! Finance
Hytrulo (efgartigimod) for a second indication — chronic inflammatory demyelinating polyneuropathy (CIDP). Vyvgart Hytrulo has been approved as a once-weekly 30-to-90-second subcutaneous injection to treat adult patients with CIDP, a rare autoimmune disease. Per argenx, the approval ofVyvgart Hytrulo makes it the first FDA-approved medication with a novel mechanism of action to treat CIDP in more than 30 years. The drug was initially approved by the FDA last year to treat adults with generalized myasthenia gravis (gMG) indication. An intravenous formulation of the drug was approved by the FDA in 2021 to treat gMG and is marketed under the trade name Vyvgart. The approval of Vyvgart/Vyvgart Hytrulo marks the first and currently the only approval for a medication based on a neonatal Fc receptor (FcRn) blocker in the United States. The latest FDA approval is based on data from the phase III ADHERE study, which evaluated the argenx drug in CIDP patients, regardless of prior treatmen Show less Read more
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