Avexitide (Exendin 9-39) - (LUCIDITY)

August 6, 2026: Amylyx Pharmaceuticals (NASDAQ: AMLX) said the last participant completed the final study visit in the 16-week double-blind portion of the pivotal Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia (PBH), with topline data expected in late August or early September 2026. LUCIDITY enrolled 78 adults with PBH after Roux-en-Y gastric bypass in a randomized, double-blind, placebo-controlled study; the FDA-agreed primary endpoint is reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16. Amylyx said it is advancing NDA readiness and pre-commercial activities for a potential 2027 launch if approved. It also started a U.S. Expanded Access Program for avexitide in May 2026.

Other programs: AMX0114 (Phase 1 LUMINA) in ALS showed no drug-related serious adverse events and no serious neurological adverse events in Cohort 1; Cohorts 1 and 2 are fully enrolled and Cohort 3 is enrolling. AMX0035 in Wolfram syndrome had published Week 24/48 Phase 2 HELIOS results and Week 96 follow-up showing generally stable or improved pancreatic function, glycemic measures, visual acuity, and symptom outcomes, with no serious treatment-related AEs; the company continues to work with FDA on a Phase 3 trial. AMX0318 IND-enabling studies are underway, with an IND filing targeted for 2027. Amylyx also entered a second research collaboration with Gubra in July 2026.