GENFIT: Historic Milestone Achieved with U.S. FDA Accelerated Approval of Ipsen's Iqirvo® for Primary Biliary Cholangitis [Yahoo! Finance]
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GENFIT S.A. - American Depositary Shares (GNFT)
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Source: Yahoo! Finance
First-ever drug developed in-house by GENFIT to achieve U.S. FDA's approval GENFIT is eligible to receive a €48.7 million milestone payment from Ipsen upon the first commercial sale of Iqirvo in the U.S., as well as tiered double-digit royalties of up to 20% Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), June 10, 2024 GENFIT (Nasdaq and Euronext: GNFT) , a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the achievement of a historic corporate milestone: the U.S. Food and Drug Administration (FDA) accelerated approval of Iqirvo (elafibranor) 80 mg tablets – as unveiled today by Ipsen (Euronext: IPN; ADR: IPSEY) – as a first-in-class treatment for PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Elafibranor will be marketed and commercialized by Ips
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- GENFIT: Historic Milestone Achieved with U.S. FDA Accelerated Approval of Ipsen’s Iqirvo® for Primary Biliary CholangitisGlobeNewswire
- Ipsen's Iqirvo® receives U.S. FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis [Financial Post (Toronto, Ontario, Canada)]Financial Post
- Ipsen's Iqirvo® receives U.S. FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis [Yahoo! Finance]Yahoo! Finance