FDA Accepts argenx's Supplemental Biologics License Application With Priority Review For VYVGART Hytrulo In Chronic Inflammatory Demyelinating Polyneuropathy
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The FDA has accepted argenx SE's supplemental Biologics License Application for VYVGART Hytrulo for priority review, targeting chronic inflammatory demyelinating polyneuropathy (CIDP). The PDUFA target action date is set for June 21, 2024. If approved, VYVGART Hytrulo will be the first neonatal Fc receptor blocker for CIDP treatment.
February 20, 2024 | 7:16 am
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argenx SE's VYVGART Hytrulo has been accepted by the FDA for priority review for CIDP treatment, with a decision expected by June 21, 2024.
The acceptance of argenx SE's supplemental Biologics License Application for VYVGART Hytrulo by the FDA for priority review is a significant positive development. This not only highlights the potential of VYVGART Hytrulo as the first treatment of its kind for CIDP but also positions argenx SE favorably in the market. The priority review status could lead to a faster approval process, potentially boosting investor confidence and positively impacting ARGX's stock price in the short term.
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