Financial StabilityGENFIT entered into a royalty financing agreement with HealthCare Royalty for up to €185M in total funding, providing financial stability and resources for future projects.
Market OpportunityRecent U.S. approval of Iqirvo in 2L PBC, coupled with negative regulatory developments for competing agent Ocaliva, set the table for a strong launch and favorable near-term economics to GNFT in the form of milestone payments and royalties.
Regulatory ApprovalIqirvo received FDA approval for the treatment of 2L primary biliary cholangitis, along with a positive opinion from the Committee for Medicinal Products for Human Use, enhancing GENFIT's market potential.