On February 12, 2026 GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, reported that the strong commercial performance of Iqirvo in its first full year on the primary biliary cholangitis (PBC) market has triggered a US$20M milestone payment from Ipsen under the companies’ licensing agreement.
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The commercial success of Iqirvo in 2025 underscores the strength of our partnership with Ipsen and exceeded our initial expectations with first-year net sales reaching US$208M. This performance activated a US$20M milestone payment ahead of plan, reinforcing GENFIT’s financial position. This momentum also led to the receipt of an additional €30M tranche under GENFIT’s royalty‑financing agreement with HCRx, enhancing financial flexibility in a non-dilutive way.
In parallel, Ipsen confirmed the initiation of the first and only global Phase 3 clinical trial in primary sclerosing cholangitis (PSC), addressing a significant unmet medical need, as no approved therapies currently exist for this severe and progressive disease. PSC represents a substantial untapped market opportunity, comparable in size to second line PBC. Should Iqirvo ultimately receive regulatory approval for this indication, GENFIT would be eligible for additional milestone payments as well as additional double‑digit royalties.
Beyond Iqirvo, GENFIT continues to advance its oncology program. The ongoing Phase 1b study in cholangiocarcinoma (CCA), evaluating GNS561 in combination with a MEK inhibitor, is progressing in line with expectations. As communicated in December 2025, early positive activity was observed in the first evaluable patients at Week 6. Enrollment for a the next escalated-dose cohort has now been completed, with no dose-limiting toxicities (DLTs) reported to date. Recruitment for the following one will now proceed, consistent with the predefined dose‑escalation process. Multi-cohort readouts on safety, tolerability and activity along with the determination of the recommended Phase 2 doses remain expected by the end of the first half of 2026.
Pascal Prigent, CEO of GENFIT declared: "We are pleased with Ipsen’s continued success with Iqirvo. Net sales have surpassed US$200M in 2025 and this remarkable performance has allowed us to get the first commercial milestone a year earlier than anticipated. We believe that this commercial trajectory has the potential to be transformative for our business model. We are also pleased with the progress of our GNS561 program, with a new cohort fully recruited. This program might bring significant hope for patients with a devastating disease, and we are eagerly awaiting new data. As we are also anticipating the first ACLF patients to be included in a phase 2 evaluating G1090N in the second half of the year we believe 2026 will be a landmark year for GENFIT."
GENFIT will publish its 4Q25 revenue and cash position on February 26, 2026.
(Press release, Genfit, FEB 12, 2026, https://ir.genfit.com/news-releases/news-release-details/genfit-receive-us20m-milestone-after-ipsens-iqirvor-exceeds [SID1234662638])