Amylyx avexitide cuts hypoglycemic events 55%

• Amylyx said avexitide reduced the combined rate of Level 2 and Level 3 hypoglycemic events by 55% versus placebo in its Phase 3 LUCIDITY trial.
• The latest available AMLX premarket trade was $21.43, down 0.88%, but that quote preceded the 7:00 a.m. ET clinical data release.
• Amylyx plans to submit an avexitide New Drug Application to the FDA by the end of 2026 and is preparing for a potential 2027 launch if approved.

Amylyx Pharmaceuticals (NASDAQ:AMLX) said avexitide met the Phase 3 LUCIDITY primary endpoint with a 55% reduction in Level 2 and Level 3 hypoglycemic events versus placebo.

The 78-participant trial achieved a p-value of 0.000003 and also met secondary endpoints covering Level 2 events measured by SMBG and CGM and independently adjudicated Level 3 events.

Avexitide was generally well tolerated, with most adverse events mild to moderate and no serious adverse events related to treatment during the 16-week double-blind period.

Avexitide has FDA Breakthrough Therapy Designation for post-bariatric hypoglycemia and Orphan Drug Designation for hyperinsulinemic hypoglycemia, while LUCIDITY's 32-week open-label extension remains underway.

Amylyx said it plans to submit an NDA by year-end and is preparing for a potential commercial launch of avexitide in 2027 if the FDA approves the treatment.