Amylyx Pharmaceuticals advanced its experimental drug avexitide toward US regulatory submission on Thursday, following late-stage trial results showing a 55% reduction in severe low-blood-sugar episodes. The Cambridge, Massachusetts-based company outlined next steps in filings and investor communications.

Avexitide, a GLP-1 receptor antagonist, targets post-bariatric hypoglycemia, a condition affecting patients who have undergone weight-loss surgery. Trial data met primary endpoints, with patients experiencing significantly fewer severe hypoglycemic events compared with placebo. Amylyx shares rose sharply after the data were released.

Amylyx executives said the company intends to seek Breakthrough Therapy designation from the US Food and Drug Administration and an accelerated review timeline. The drug previously received orphan drug status for the indication, which currently has no approved treatments.

Investment bank analysts covering the stock said the results position Amylyx to capture a growing market tied to bariatric and GLP-1-related metabolic patients. The company has been seeking new revenue streams after setbacks with its earlier neurological drug.

Amylyx said full trial data will be presented at an upcoming medical conference and submitted for peer-reviewed publication. The company plans to provide additional regulatory timing details during its next quarterly earnings update.