Avexitide (Exendin 9-39) - (LUCIDITY)

August 18, 2026: Amylyx Pharmaceuticals (NASDAQ: AMLX) reported positive topline Phase 3 LUCIDITY results for avexitide in post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass. In the 78-patient, randomized, double-blind, placebo-controlled trial, avexitide met the FDA-agreed primary endpoint, reducing the composite rate of Level 2 and Level 3 hypoglycemic events by 55% versus placebo through Week 16 (p=0.000003). The study also met all secondary endpoints, with statistically significant reductions in Level 2 events measured by self-monitoring of blood glucose and continuous glucose monitoring, and in independently adjudicated Level 3 events.

Avexitide was generally well tolerated; most adverse events were mild to moderate, there were no serious adverse events related to treatment, and the most common adverse events were diarrhea, injection site erythema, and injection site bruising. No body weight changes were observed over 16 weeks.

Amylyx said it plans to submit an NDA to the FDA by the end of 2026. Avexitide has FDA Breakthrough Therapy and Orphan Drug designations for PBH. The 32-week open-label extension and expanded access program remain ongoing, and the company plans to present LUCIDITY data at an upcoming medical meeting.