Argenx SE (NASDAQ: ARGX) has disclosed Monday that it has entered into an agreement to buy FDA Priority Review Voucher (PRV) from Bayer Healthcare Pharmaceuticals, Inc. for $98 million. This voucher enables its holder to an FDA priority review of A Biologics License Application (BLA), which decreases the target review time and may lead to an expedited approval.
The company is planning to purchase the PRV for the future market application for its FcRn antagonist efgartigimod. Efgartigimod is beneficial for patients who are suffering from autoimmune diseases. The deal will be executed after fulfilling the closing conditions.