Yesterday during trading hours, the FDA flagged worsening of CIDP with Vyvgart Hytrulo as a new safety signal via a routine update to the FDA adverse event reporting system (FAERS), which sent the argenx' stock down approx. 8%. While CIDP worsening was also reported in patients switching between treatments from IVig to SCig in the PATH study, physicians navigate treatment switches carefully, and based on argenx' own post-marketing surveillance,
argenx announced its plan to advance the clinical development of ARGX-119 (muscle-specific kinase [MuSK] agonist antibody) to a registrational study in patients with congenital myasthenic syndromes (CMS) following the analysis of topline data from the phase 1b study, which showed consistent improvements through the 12-week study across multiple efficacy scores. This marks the 3rd candidate to advance to phase 3 from argenx' internal pipeline, which in our view supports the company's future growt...
argenx Advances Clinical Development of ARGX-119 in Congenital Myasthenic Syndromes Phase 1b study supports proof-of-concept in DOK7 congenital myasthenic syndromes Decision informed by favorable safety profile and consistent functional improvement over time across multiple efficacy measures Advancing ARGX-119 further validates strong track record of Immunology Innovation Program (IIP), argenx's collaborative discovery model June 30, 2025, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of p...
argenx announced that the European Commission (EC) approved Vyvgart SC for the treatment of adults with progressive or relapsing active CIDP after prior treatment with corticosteroids or immunoglobulins, which comes in line with expectations following the positive CHMP opinion issued in April 2025. We anticipate a steady country by country EU launch, and continue to expect the US to remain the main driver for Vyvgart's commercial launch. We currently estimate approx. $ 1.1bn in peak sales for CI...
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