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Amylyx awaits Phase 3 LUCIDITY readout for avexitide
The Phase 3 trial is set to assess reductions in Level 2 and Level 3 hypoglycemic events through Week 16 in patients with post-bariatric hypoglycemia.
Amylyx Pharmaceuticals is set for a high-stakes Phase 3 readout for avexitide, after releasing topline results from its LUCIDITY trial on August 18, 2026. Shares closed Monday down 0.9% at $21.43, then rose 15.7% in after-hours trading to $24.80 ahead of any efficacy or safety data.
LUCIDITY randomized 78 adults with post-bariatric hypoglycemia after Roux-en-Y gastric bypass in a 3:2 ratio to receive once-daily avexitide or placebo. The FDA-agreed primary endpoint is the reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16.
Avexitide is designed to block an exaggerated GLP-1 response that can drive excess insulin secretion and dangerous drops in blood glucose. The trial outcome is framed as central to whether Amylyx can move beyond its prior ALS-focused narrative, as the company currently has no approved product.
Ahead of the Phase 3 results, the company pointed to supportive earlier studies, including a 28-day open-label Phase 2b crossover study of 16 patients where the 90 mg once-daily dose reduced Level 2 events by 53% and Level 3 events by 66% versus a medical nutrition therapy-only run-in baseline. The FDA has granted Breakthrough Therapy designation for post-bariatric hypoglycemia, and management has anticipated a potential 2027 launch if approved, while the company reported $250.8 million in cash, cash equivalents, and short-term investments.