GENFIT Updates 2024 Outlook Following Acceptance of Elafibranor Filings

 

• US Food and Drug Administration (FDA) has granted Priority Review for New Drug Application (NDA) for elafibranor in PBC, and European Medicine Agency (EMA) has also validated the Marketing Authorization Application (MAA) for elafibranor.

• Acceptance triggers a first milestone payment. Further milestones are expected upon US and European launches which could now happen in 2Q24 in the US (FDA PDUFA¹ action date: June 10, 2024) and 2H24 in Europe. These milestones total approximately 89M€.
• Launches in the US and Europe will also make GENFIT eligible for royalty payments.
• Revenues will fund the development of GENFIT’s pipeline, now mainly focused on Acute On-Chronic Liver Failure (ACLF) with 5 differentiated assets.

https://www.biospace.com/article/releases/genfit-updates-2024-outlook-following-acceptance-of-elafibranor-filings-in-primary-biliary-cholangitis-pbc-/