Avexitide (Exendin 9-39) - (LUCIDITY)

May 5, 2026: Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) launched a U.S. Expanded Access Program (EAP) for up to 250 adults with post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass surgery to provide treatment access to avexitide, an investigational, first-in-class GLP-1 receptor antagonist. The EAP allows U.S. physicians to request avexitide for eligible adults with serious unmet need who cannot participate in ongoing clinical trials and have exhausted available management options; initial eligible patients include those who completed the Phase 3 LUCIDITY trial and participants from prior avexitide PBH trials.

Avexitide is not FDA-approved for any indication. It is being evaluated in the pivotal Phase 3 LUCIDITY trial (NCT06747468), a 78-participant, multicenter, randomized, double-blind, placebo-controlled study (90 mg SC once daily vs placebo; 3:2 randomization) with a primary endpoint of reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16; a 32-week open-label extension follows. Topline Phase 3 data are anticipated in Q3 2026, and if approved, commercial launch is anticipated in 2027.