On Tuesday, Amylyx Pharmaceuticals (AMLX.US) saw its stock price climb sharply by nearly 51%, reaching $32.33 per share.
The surge followed the company's announcement on August 18 that the Phase 3 LUCIDITY trial of its GLP-1 receptor antagonist, Avexitide, met its primary endpoint in treating post-bariatric hypoglycemia (PBH). Compared to a placebo, patients experienced a 55% reduction in Grade 2 and Grade 3 hypoglycemic events by week 16 of the study.
The trial also achieved all secondary endpoints, demonstrating statistically significant and clinically meaningful reductions across multiple glucose monitoring measures. Avexitide was generally well-tolerated, with no treatment-related serious adverse events or changes in body weight reported.
Amylyx Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing novel therapies for communities with high unmet medical needs. The company is currently advancing preclinical and clinical development programs in both endocrine diseases and neurodegenerative disorders.
Looking ahead, the company plans to submit a New Drug Application (NDA) for Avexitide to the U.S. Food and Drug Administration (FDA) by the end of 2026. If approved, a potential commercial launch is targeted for 2027.