Amylyx Drug Cuts Dangerous Low Blood Sugar Episodes by 55 percent

Amylyx Pharmaceuticals’ low blood sugar drug avexitide has delivered strong results in a late-stage trial.

The experimental treatment cut hypoglycemic episodes by 55 percent versus placebo. The results came from a 78-patient trial involving people who had undergone weight-loss surgery.

The trial met its main goal after 16 weeks. The results also pushed Amylyx shares more than 45 percent higher during Tuesday trading. The stock reached $31.72 in morning trading. The jump could add about $1.15 billion to the company’s market value.

Avexitide Shows Strong Results in Phase 3 Trial

The trial evaluated avexitide in patients with post-bariatric hypoglycemia. This condition can develop after Roux-en-Y gastric bypass surgery. It can cause serious low blood sugar episodes in affected patients. Avexitide is a once-daily injection. It works by blocking certain GLP-1 receptors in the pancreas. This helps reduce excessive insulin secretion and stabilize blood glucose levels.

Key results from the trial include:

• 78 patients took part in the late-stage study.
• Avexitide reduced hypoglycemic episodes by 55 percent versus placebo.
• The treatment met the trial’s primary goal.
• Reported side effects were mostly mild to moderate.
• Diarrhea and bruising were among the reported side effects.
• The treatment was generally well tolerated.

Dr. Marilyn Tan, the trial’s lead investigator, said patients want fewer hypoglycemia events. This could help them live more independently without constant fear. Post-bariatric hypoglycemia currently has no approved treatments. Doctors typically manage the condition through diet changes and blood sugar monitoring. Carbohydrate-blocking medicines may also be used.

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Amylyx Eyes FDA Filing and 2027 Launch

The trial results could give Amylyx a major boost after a difficult period. The company withdrew its ALS drug Relyvrio from the market in 2024. The move followed a failed late-stage trial and led to layoffs and restructuring. Amylyx now plans to move quickly toward a U.S. marketing application. The company expects to file with the FDA by the end of 2026. It is targeting a commercial launch in 2027.

The company had $250 million in cash on hand. This gives Amylyx financial support as it prepares for the next stage of avexitide’s development. The drug also has significant commercial potential. TD Cowen analysts estimate peak U.S. sales could reach $2.2 billion.

Amylyx acquired avexitide from Eiger BioPharmaceuticals in 2024. The deal was completed for $35.1 million during Eiger’s bankruptcy auction.

Avexitide Could Open a Major New Market

The strong trial results have shifted investor attention toward the drug’s commercial prospects. Analysts are now watching the FDA filing and potential label for avexitide. Citi analyst Geoffrey Meacham said attention will now focus on filing acceptance and label breadth.

Launch execution will also be important in this underrecognized market. For patients who develop low blood sugar after bariatric surgery, a successful approval could offer a new treatment option. For Amylyx, avexitide could also become a key driver of its next phase of growth.