argenx FDA FAERS reporting flags Vyvgart Hytrulo in routine update
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, <2% of patients have reported worsening of their CIDP when transitioning treatment despite the growth in uptake. As such, we continue to feel confident in Vyvgart Hytrulo and see any weakness in the shares as a buying opportunity. We reiterate our € 670 TP and Accumulate rating.Argenx N.V. is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer. Utilizing its suite of differentiated technologies, Co. is focused on developing product candidates with the potential to be either first-in-class against novel targets or best-in-class against known, but complex, targets in order to treat diseases with a significant unmet medical need.
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