GENFIT to receive US$20M milestone after Ipsen's Iqirvo® exceeds the US$200M threshold in its first full year of net sales

Core Insights - GENFIT announced a strong commercial performance of Iqirvo® in its first full year, achieving net sales of US$208M, which triggered a US$20M milestone payment from Ipsen ahead of schedule [2][8] - The partnership with Ipsen is highlighted as a key factor in the commercial success, reinforcing GENFIT's financial position and leading to an additional €30M tranche under a royalty-financing agreement with HCRx [2][3] - Ipsen has initiated a Phase 3 clinical trial for Iqirvo® in primary sclerosing cholangitis (PSC), representing a significant market opportunity, with potential for additional milestone payments and royalties for GENFIT [3][8] Financial Performance - Iqirvo® net sales reached US$208M in 2025, with US$88M reported in Q4 2025 [2][8] - The early achievement of the milestone payment is expected to enhance GENFIT's financial flexibility [2] - The company anticipates a landmark year in 2026, with ongoing clinical programs and new data expected [5] Clinical Development - GENFIT is advancing its oncology program, specifically the Phase 1b study of GNS561 in cholangiocarcinoma (CCA), which is progressing as planned with no dose-limiting toxicities reported [4][8] - Recruitment for the next dose-escalation cohort has been completed, with multi-cohort readouts expected by the end of the first half of 2026 [4][8] - The company is also preparing for a Phase 2 study evaluating G1090N in acute on-chronic liver failure (ACLF) patients [5] Company Overview - GENFIT is focused on rare and life-threatening liver diseases, with a strong history in liver disease research and development [7] - The company has a diverse R&D portfolio, including therapies for cholangiocarcinoma, urea cycle disorders, and organic acidemias [9] - GENFIT is headquartered in Lille, France, and is listed on the Euronext regulated market [9]