Iqirvo - (ELSPIRE)

November 5, 2026: Ipsen (Euronext: IPN, OTC: IPSEY) reported late-breaking Phase III ELSPIRE data for IQIRVO (elafibranor) in primary biliary cholangitis patients with ALP 1 to 1.67× ULN despite inadequate response or intolerance to ursodeoxycholic acid. At Week 52, 85.3% on IQIRVO achieved ALP normalization versus 23.3% on placebo (p<0.0001), meeting the primary endpoint. IQIRVO also showed a 36.5% mean ALP reduction from baseline versus 4.2% with placebo (p<0.0001), 84.5% achieved ALP normalization plus at least 15% reduction from baseline versus 20.0% (p<0.0001), complete biochemical response in 64.3% versus 16.7% (p<0.0001), and improved total bilirubin (p=0.0260) and GGT (p=0.0002). The drug was generally well tolerated with no new safety signals.

These ELSPIRE results will be presented at AASLD The Liver Meeting 2026 and published in Hepatology; Ipsen said the expanded-population data are being shared with regulators.

Ipsen also disclosed six-month Phase IV ELFINITY real-world data: 57.5% (65/113) of evaluable patients met the biochemical response endpoint, while patients with moderate-to-severe baseline fatigue or pruritus showed clinically meaningful symptom improvements across fatigue and itch measures.