GENFIT Receives $20M Milestone as Iqirvo Exceeds $200M Sales Threshold in First Year
核心洞察
GENFIT will receive a $20 million milestone payment from Ipsen after Iqirvo achieved $208 million in net sales during its first full year on the primary biliary cholangitis (搜索) market, exceeding the $200 million threshold ahead of schedule.
Ipsen confirmed its commitment to launch a Phase 3 clinical trial for Iqirvo in primary sclerosing cholangitis (搜索), representing a significant untapped market opportunity comparable in size to second-line PBC treatment.
GENFIT's oncology program continues to advance with its Phase 1b cholangiocarcinoma (搜索) study progressing as planned, with a new dose-escalation cohort fully enrolled and no dose-limiting toxicities reported.
GENFIT announced that the exceptional commercial performance of Iqirvo (elafibranor) has triggered a $20 million milestone payment from partner Ipsen, marking a significant financial achievement for the French biopharmaceutical company. The drug achieved $208 million in net sales during 2025, its first full year on the primary biliary cholangitis (搜索) (PBC) market, surpassing the contractual threshold of $200 million ahead of schedule.
Strong Commercial Performance Drives Early Milestone
Ipsen reported $88 million in Iqirvo net sales for the fourth quarter of 2025, bringing total annual sales to $208 million. This performance exceeded initial expectations and activated the milestone payment one year earlier than anticipated. The commercial success also triggered an additional €30 million tranche under GENFIT's royalty-financing agreement with HCRx (搜索), providing enhanced financial flexibility through non-dilutive funding.
"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," stated Pascal Prigent, CEO of GENFIT. "We believe that this commercial trajectory has the potential to be transformative for our business model."
Phase 3 Trial Planned for Primary Sclerosing Cholangitis
Ipsen confirmed its commitment to initiate the first and only global Phase 3 clinical trial evaluating Iqirvo in primary sclerosing cholangitis (搜索) (PSC), addressing a significant unmet medical need. Currently, no approved therapies exist for this severe and progressive liver disease. PSC represents a substantial market opportunity comparable in size to second-line PBC treatment.
Should Iqirvo ultimately receive regulatory approval for PSC, GENFIT would be eligible for additional milestone payments and double-digit royalties, potentially expanding the drug's commercial impact beyond its current PBC indication.
Oncology Program Advances with Positive Early Signals
GENFIT's Phase 1b study in cholangiocarcinoma (搜索) (CCA) continues to progress according to plan, evaluating GNS561 in combination with a MEK (搜索) inhibitor. The company reported that enrollment for the next escalated-dose cohort has been completed, with no dose-limiting toxicities reported to date at the 21-day timepoint.
Early positive activity was observed in the first evaluable patients at Week 6, as previously communicated in December 2025. Multi-cohort readouts on safety, tolerability, and activity, along with determination of recommended Phase 2 doses, remain expected by the end of the first half of 2026.
Pipeline Expansion into Acute-on-Chronic Liver Failure
Looking ahead, GENFIT anticipates including the first acute-on-chronic liver failure (搜索) (ACLF) patients in a Phase 2 study evaluating G1090N in the second half of 2026. This represents another avenue for the company's focus on rare, life-threatening liver diseases with significant unmet medical needs.
"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," Prigent noted. "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."
About Iqirvo and GENFIT's Portfolio
Iqirvo (elafibranor) received accelerated approval in 2024 from the U.S. Food and Drug Administration, European Medicines Agency, and the UK's Medicines and Healthcare products Regulatory Agency for treating primary biliary cholangitis (搜索). The drug is now marketed in several countries by Ipsen.
GENFIT, a BCorp-certified company since 2025, focuses on developing therapies for rare, life-threatening liver diseases. Beyond Iqirvo, the company's portfolio includes therapeutic assets targeting acute-on-chronic liver failure (搜索), cholangiocarcinoma (搜索), urea cycle disorders, and organic acidemia, along with diagnostic tools including NIS2+ for detecting metabolic dysfunction-associated steatohepatitis.
The company will publish its fourth quarter 2025 revenue and cash position on February 26, 2026.