Amylyx Pharmaceuticals Surges Over 50% After Avexitide Hits Primary Endpoint in Phase 3 LUCIDITY Trial

Amylyx Pharmaceuticals stock surged as much as 53% on August 18, hitting a 52-week high of $29.86, after the company reported positive topline results from its Phase 3 LUCIDITY clinical trial of avexitide in post-bariatric hypoglycemia. The 78-participant, multicenter, randomized, double-blind, placebo-controlled trial met its FDA-agreed primary endpoint, with avexitide delivering a 55% reduction in composite Level 2 and Level 3 hypoglycemic events versus placebo, with a p-value of 0.000003. All secondary endpoints were also met, including statistically significant reductions in Level 2 hypoglycemic events as 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 first-in-class GLP-1 receptor antagonist that holds FDA Breakthrough Therapy designation. The drug targets post-bariatric hypoglycemia, a serious complication following Roux-en-Y gastric bypass surgery for which no approved treatment currently exists. Amylyx plans to submit an NDA for avexitide in post-bariatric hypoglycemia by the end of 2026, and the company is also developing a longer-acting GLP-1 antagonist, AMX0318.

Seeking Alpha upgraded the stock to Strong Buy following the results, while at least one analyst commentary urged caution despite the trial success.