Amylyx to seek FDA approval for avexitide after Phase 3 success in post-bariatric hypoglycemia

Amylyx announced plans to file a new drug application for avexitide, a GLP-1 receptor antagonist, after a Phase 3 trial showed reduction in serious hypoglycemia in patients who had gastric bypass surgery.

The trial reported fewer moderate and severe hypoglycemic episodes compared with baseline, giving the company a clear path toward FDA review.

Analysts estimate the drug could address a rare but sizable market of roughly 160,000 patients in the United States, with potential worldwide peak sales of about $1.7 billion.

Unlike existing GLP-1 agonists that activate the receptor, avexitide blocks it, offering a different therapeutic approach for post-bariatric hypoglycemia.