AMLX Amylyx

Amylyx to Present Phase 3 LUCIDITY Topline Data for Avexitide at ObesityWeek 2026

Amylyx will present topline results from the Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia as a late-breaking oral presentation at the ObesityWeek 2026 Annual Meeting on November 15, 2026. This follows the positive topline announcement from August 2026. Avexitide holds Breakthrough Therapy, Orphan Drug, and Rare Pediatric Disease designations from the FDA.

Amylyx: LUCIDITY Phase 3 topline positive for avexitide in PBH

LUCIDITY met its FDA-agreed primary endpoint with a 55% reduction in Level 2/3 hypoglycemic events (p=0.000003) and all secondary endpoints. Amylyx plans to submit an NDA for avexitide by year-end 2026.

Amylyx completes enrollment in Phase 3 LUCIDITY trial of avexitide

Enrollment of 78 participants is now complete in the pivotal Phase 3 LUCIDITY trial. The FDA-agreed primary endpoint is reduction in Level 2 and Level 3 hypoglycemic events through Week 16. Topline data readout remains on track for Q3 2026.