Key Highlights

  • Amylyx Pharmaceuticals shares closed up 64% at $35.11.
  • Avexitide reached its primary FDA-agreed endpoint in the Phase 3 LUCIDITY study for post-bariatric hypoglycemia.
  • The GLP-1 receptor antagonist demonstrated a 55% decrease in Level 2/3 hypoglycemic events relative to placebo.
  • The trial successfully fulfilled all secondary endpoints, supporting a planned year-end 2026 NDA submission.

Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) shares closed up 64% at $35.11 after the company reported that avexitide reached its primary FDA-agreed endpoint in the Phase 3 LUCIDITY study for post-bariatric hypoglycemia (PBH).

What Happened

In the trial, the GLP-1 receptor antagonist demonstrated a 55% decrease in Level 2/3 hypoglycemic events relative to placebo and successfully fulfilled all secondary endpoints.

Market Reaction

Shares surged sharply as investors responded to the strength of the primary and secondary endpoint results, positioning avexitide as a potential first approved treatment for a condition with no current FDA-approved therapy.

Outlook

These results support a planned year-end 2026 NDA submission, positioning the therapy to potentially become the first approved treatment for PBH.