argenx SE (ARGX) introduced an settlement to amass a FDA Precedence Evaluate Voucher for $102 million. The corporate expects to redeem the PRV for a future advertising utility for efgartigimod, its neonatal Fc receptor blocker.
“Now we have demonstrated proof-of-concept in 4 autoimmune ailments with our first-in-class FcRn blocker, efgartigimod, and are planning to be energetic in fifteen illness targets by 2025. With a precedence evaluation voucher out there, we hope to expedite the approval course of for considered one of our present or future indications,” stated Tim Van Hauwermeiren, CEO of argenx.
A PRV entitles the holder to FDA precedence evaluation of a single Biologics License Software.
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