argenx FDA approves Vyvgart Hytrulo as pre-filled syringe for MG and CIDP
argenx obtained FDA approval for a PFS presentation of Vyvgart Hytrulo for self-injection for patients with AChR+ gMG or CIDP. The 20-30 second injection can now be administered by patients themselves after proper instruction, freeing them to receive treatment in healthcare settings, at home or on the go. With no specific monitoring or training requirements, the label provides a lot of flexibility for patients. We see the approval as the next phase in maintaining Vyvgart's launch momentum as it will further enable access to earlier-line patients. 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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