Argenx To Acquire FDA Priority Review Voucher - Quick Facts

argenx SE (ARGX) announced an agreement to acquire a FDA Priority Review Voucher for $102 million. The company expects to redeem the PRV for a future marketing application for efgartigimod, its neonatal Fc receptor blocker.

"We have demonstrated proof-of-concept in four autoimmune diseases with our first-in-class FcRn blocker, efgartigimod, and are planning to be active in fifteen disease targets by 2025. With a priority review voucher available, we hope to expedite the approval process for one of our current or future indications," said Tim Van Hauwermeiren, CEO of argenx.

A PRV entitles the holder to FDA priority review of a single Biologics License Application.

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