Amylyx reports Q3 EPS (37c), consensus (43c)

“Entering the final months of 2025, we are focused on execution as we head toward a transformative year in 2026, with topline data expected from the pivotal Phase 3 LUCIDITY trial,” said Joshua Cohen and Justin Klee, Co-CEOs of Amylyx (AMLX). “We continue to advance our lead asset avexitide, an investigational, first-in-class inhibitor of GLP-1 receptor activity with FDA Breakthrough Therapy Designation. We continue to see high participant interest and broad engagement across LUCIDITY clinical trial sites, reflecting the significant unmet need for PBH across the U.S. Based on our most recent projections of the trial enrollment rate, we expect completion of recruitment in Q1 2026, with topline data expected in Q3 2026. Our previous estimates assumed a ramp in the enrollment rate at this stage of the trial, but we have seen more of a steady enrollment rate in the last few weeks. Timing remains unchanged for the potential launch of avexitide, if approved, and we are executing on plans to be launch ready in 2027.”