IQIRVO (elafibranor) demonstrates statistically significant improvement in ALP normalization in patients with PBC in Phase IIIb ELSPIRE study

• Ipsen announced that its Phase 3b ELSPIRE trial (N=92; PCD: Jun 2026) evaluating Iqirvo (elafibranor; PPARα/δ agonist) in patients with PBC and ALP 1-1.67x ULN met its primary endpoint of ALP normalization at Week 52. Additionally, Ipsen guided for a full data presentation at an upcoming medical conference and a submission to regulatory authorities (no specific timelines disclosed) (07/13/2026)

• The timing of the topline results is in line with previous company guidance, which indicated the trial to be unblinded "this summer" with the announcement to be made via press release
  • The primary endpoint of ALP normalization (≤1x ULN) at Week 52 was achieved in 85% of Iqirvo-treated patients vs 23% on placebo (p<0.0001)
  • The safety profile was consistent with the known profile of Iqirvo, with no new safety signals identified
• Ipsen plans to present the data at an upcoming medical meeting and submit to regulatory authorities (no specific timelines disclosed)
• Ipsen indicated that treating the ALP 1–1.67x ULN population had the potential to double the addressable population for Iqirvo

• Ipsen updated the status of its Phase 3b ELSPIRE trial to "Completed", (previously “Active, not recruiting”) with actual enrolment number revised to 92 patients (previously, 69 patients) (07/09/2026)

• The actual trial PCD/SCD was updated to July 16, 2026 (previously estimated for July 26, 2026)

Press Release