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Argenx To Buy FDA Priority Review Voucher From Bayer Healthcare For $98 Mln

argenx (ARGX) said that it agreed to acquire a U.S. Food and Drug Administration Priority Review Voucher or PRV from Bayer Healthcare Pharmaceuticals Inc for $98 million.

A Priority Review Voucher entitles the holder to FDA priority review of a single New Drug Application or Biologics License Application, which reduces the target review time and may potentially lead to an expedited approval.

argenx said it expects to redeem the PRV for a future marketing application for its FcRn antagonist efgartigimod. It will not be used for the BLA filing of intravenous efgartigimod in generalized myasthenia gravis, which is on track to be submitted in 2020.

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