Argenx announced positive top-line results from its phase 3 trial of Vyvgart in autoimmune myositis, or IIM, with the study meeting its primary endpoint at week 52 in the combined patient population of immune-mediated necrotizing myopathy and dermatomyositis. Shares soared 16% on Aug. 17.
Novel FcRn inhibitor Vyvgart is a pipeline in a product, currently approved in myasthenia gravis and CIDP in the US, but it's being evaluated in multiple additional indications.
Bears
Vyvgart’s initial average price in myasthenia gravis of $225,000 per year per patient in the US could fall over time, as international launches progress and as competitors reach the market.
Argenx is a Dutch biopharmaceutical company focused on developing antibody-based therapies for rare autoimmune diseases. The company’s lead product, Vyvgart (efgartigimod), was approved by the FDA in December 2021 for the treatment of generalized myasthenia gravis (gMG). In 2022, Argenx also received FDA approval for Vyvgart Hytrulo, a subcutaneous formulation of Vyvgart, offering a more convenient option compared with Vyvgart’s intravenous administration. In 2024, the FDA approved Vyvgart Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy, a rare immune-mediated neuromuscular disorder of the peripheral nervous system. Argenx is focused on innovation and developing its pipeline for treatments such as primary immune thrombocytopenia, thyroid eye disease, and Sjogren's Disease.