Amylyx LUCIDITY Trial Hits Primary Endpoint With 55% Reduction in Hypoglycemic Events, Stock Surges 30%

Amylyx Pharmaceuticals reported on August 18 that its Phase 3 LUCIDITY trial of avexitide met the FDA-agreed primary endpoint, delivering a 55% reduction in composite Level 2 and Level 3 hypoglycemic events versus placebo, with a p-value of 0.000003. The 78-participant, multicenter, randomized, double-blind, placebo-controlled trial evaluated the drug in patients with post-bariatric hypoglycemia following Roux-en-Y gastric bypass surgery. All secondary endpoints were also met, including statistically significant reductions in Level 2 hypoglycemic events measured by both self-monitoring of blood glucose and continuous glucose monitoring, as well as Level 3 events.

Avexitide is a once-daily injectable and a first-in-class GLP-1 receptor antagonist that holds FDA Breakthrough Therapy Designation for this indication. Shares of AMLX surged more than 30% in pre-market trading on the news, having been reported up roughly 21% in early trading. The company has said its cash runway extends through potential commercialization and into 2028, and the strength of the data is expected to support a new drug application filing.