Amylyx Pharmaceuticals, Inc. — Form 8-K

LUCIDITY, a 78-participant Phase 3 trial, met its FDA-agreed primary endpoint with avexitide demonstrating a 55% reduction in composite Level 2 and Level 3 hypoglycemic events versus placebo (p=0.000003). All secondary endpoints were also met. Avexitide has Breakthrough Therapy and Orphan Drug Designations; the company plans NDA submission by end of 2026, targeting potential 2027 commercial launch. No serious adverse events related to avexitide were reported; most adverse events were mild to moderate (diarrhea, injection site reactions).