Amylyx reported a Phase 3 success for avexitide (a GLP-1 receptor antagonist) in post-bariatric hypoglycemia, showing a 55% reduction in serious hypoglycemic events versus placebo in a pivotal trial. The readout positions the company to seek U.S. FDA approval as a first targeted therapy for PBH, a condition that can include medical emergencies following gastric bypass. The trial design was powered to detect a 35% improvement; Amylyx said results exceeded expectations, with benefit framed around clinically meaningful reductions in severe low-blood-sugar episodes. The company’s statements also highlighted effect size as a key proof point for potential adoption by clinicians managing refractory PBH. Separately, industry coverage in STAT+ and related reporting indicated the focus now shifts to regulatory next steps, labeling expectations, and how quickly prescribers may adopt avexitide in post-bariatric populations.