Amylyx Pharmaceuticals updated its corporate presentation for investor meetings, reflecting completion of enrollment in the Phase 3 LUCIDITY trial for avexitide in post-bariatric hypoglycemia (PBH), an addition to the exploratory analysis of the Phase 2 PREVENT study, and completion of enrollment for Cohort 2 in the Phase 1 LUMINA trial for AMX0114. Topline data from LUCIDITY is expected in Q3 2026, with commercial launch anticipated in 2027 if approved.
Key takeaways
Enrollment completed in Phase 3 LUCIDITY trial for avexitide in PBH (FDA-agreed primary outcome: reduction in composite Level 2 and Level 3 hypoglycemic events through Week 16)
Topline data from LUCIDITY expected Q3 2026
Commercial launch of avexitide anticipated 2027 if approved
Completed enrollment in Cohort 2 (n=12) of Phase 1 LUMINA trial for AMX0114 in ALS in March 2026
Addition to exploratory analysis of Phase 2 PREVENT study (previously presented at ENDO 2025 Annual Meeting)
Pending FDA alignment, plan to initiate pivotal Phase 3 trial of AMX0035 in Wolfram syndrome