Amylyx drug avexitide reduces severe low blood sugar episodes in post-bariatric surgery patients

Amylyx Pharmaceuticals announced that its experimental drug avexitide reduced low blood sugar episodes by 55% in a Phase 3 trial of 78 patients with post-bariatric hypoglycemia. The once-daily injection exceeded analyst expectations and safety profiles showed it was well-tolerated. Amylyx plans to seek U.S. regulatory approval by late 2026, targeting a potential 2027 launch for a condition that currently has no approved treatments and affects 8% of U.S. weight-loss surgery patients.

Avexitide Phase 3 trial results

• ▪The 55% reduction in low blood sugar episodes achieved by avexitide exceeded the 35% to 50% reduction forecast by H.C. Wainwright analysts.
• ▪In a 78-patient Phase 3 trial, Amylyx Pharmaceuticals' once-daily injection avexitide reduced low blood sugar episodes by 55% compared to placebo over 16 weeks.
• ▪The 55% reduction in low blood sugar episodes achieved by avexitide exceeded the 35% improvement the Phase 3 trial was statistically powered to show.

Post-bariatric hypoglycemia condition

• ▪Post-bariatric hypoglycemia can cause significant cognitive or physical impairment, loss of consciousness, or seizures.
• ▪There are currently no approved treatments for post-bariatric hypoglycemia, forcing patients to manage the condition through dietary changes, blood sugar monitoring, and carbohydrate-blocking medications.
• ▪Post-bariatric hypoglycemia is a condition marked by dangerously low blood sugar levels that affects approximately 8% of weight-loss surgery patients in the United States.

GLP-1 receptor blocking mechanism

• ▪Avexitide stabilizes blood glucose levels by blocking GLP-1 receptors on insulin-producing cells in the pancreas to reduce excess insulin secretion.
• ▪Avexitide is administered as a once-daily injection designed to target GLP-1 receptors on insulin-producing cells in the pancreas.

Safety profile tolerability data

• ▪Avexitide was well-tolerated in the trial, with mild to moderate diarrhea and bruising at the injection site being the most common side effects.
• ▪No changes in body weight were observed in either the avexitide or placebo groups over the 16-week treatment period.

U.S. regulatory approval timeline

• ▪Following the trial results, shares of Amylyx Pharmaceuticals rose by over 30% in premarket trading on August 18, 2026.
• ▪Amylyx Pharmaceuticals plans to submit avexitide for U.S. regulatory approval by the end of 2026, aiming for a potential commercial launch in 2027.

Commercial sales projections

• ▪Amylyx Pharmaceuticals acquired avexitide from Eiger BioPharmaceuticals for $35.1 million in 2024 during Eiger's bankruptcy auction.
• ▪TD Cowen analysts projected peak United States sales of $1.5 billion for Amylyx Pharmaceuticals' experimental drug avexitide.

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