Amylyx Pharmaceuticals stock surges after avexitide Phase 3 trial meets endpoints

Shares of Amylyx Pharmaceuticals surged on Tuesday after the biotechnology company reported positive Phase 3 clinical trial results for its experimental drug, avexitide, a potential first treatment for a serious complication of weight-loss surgery. The strong data from the pivotal LUCIDITY trial sent the company’s stock rallying more than 10% during regular trading hours, extending gains that began after-hours Monday.

The trial, which enrolled 78 adults with postbariatric hypoglycemia following Roux-en-Y gastric bypass surgery, met its primary endpoint. Participants receiving avexitide experienced a 55% reduction in severe hypoglycemic events compared to those given a placebo over a 16-week period. The company reported a highly statistically significant result, with a p-value of 0.000003. Avexitide also met all of its predetermined secondary endpoints, including measures from patient fingerstick and continuous glucose monitoring.

Postbariatric hypoglycemia (PBH) is a condition where patients suffer dangerously low blood sugar after eating, often years following procedures like sleeve gastrectomy or gastric bypass. It can lead to cognitive dysfunction, seizures, and loss of...