ReutersReuters

Argenx Enters Deal To Acquire Priority Review Voucher

ARGENX SE ARGX:

  • ARGENX ENTERS INTO AGREEMENT TO ACQUIRE PRIORITY REVIEW VOUCHER

  • CLOSING OF ACQUISITION OF PRV IS SUBJECT TO CUSTOMARY CLOSING CONDITIONS, INCLUDING CLEARANCE UNDER HART-SCOTT RODINO (HART-SCOTT-RODINO) ANTITRUST IMPROVEMENTS ACT

  • EXPECTS TO REDEEM PRV FOR A FUTURE MARKETING APPLICATION FOR EFGARTIGIMOD, ITS FIRST-IN-CLASS NEONATAL FC RECEPTOR (FCRN) BLOCKER

  • ANNOUNCED AN AGREEMENT TO ACQUIRE A U.S. FOOD AND DRUG ADMINISTRATION (FDA) PRIORITY REVIEW VOUCHER (PRV) FOR $102 MILLION

  • A PRV ENTITLES HOLDER TO FDA PRIORITY REVIEW OF A SINGLE BIOLOGICS LICENSE APPLICATION (BLA), WHICH REDUCES TARGET REVIEW PERIOD AND MAY LEAD TO AN EXPEDITED APPROVAL

התחבר או צור חשבון בחינם לתמיד כדי לקרוא את החדשות האלה