Amylyx Pharmaceuticals said its GLP-1 receptor antagonist avexitide hit the primary endpoint in a pivotal Phase 3 trial in post-bariatric hypoglycemia (PBH), with a statistically significant reduction in serious hypoglycemic events versus placebo. The topline results add to the company’s push to secure FDA approval for what is described as a first potential treatment for PBH. Across the trial population, Amylyx reported a 55% reduction in the rate of serious low blood sugar events compared with placebo, exceeding the 35% improvement target used for statistical power. The company framed the benefit as clinically meaningful for patients and families given the risk profile of severe hypoglycemia after bariatric procedures. The PBH program follows Amylyx’s broader strategic shift toward endocrine development. Several industry observers are now focused on how quickly the company can move toward regulatory filing and what the label could require for patient selection and monitoring.