Amylyx says FDA grants avexitide Breakthrough Therapy, Orphan Drug status for post-bariatric hypoglycemia
AMLX•FDA designations support avexitide program
Amylyx says it plans to submit an FDA New Drug Application for avexitide in post-bariatric hypoglycemia by year-end 2026.
- Phase 3 LUCIDITY met the FDA-agreed primary endpoint, cutting Level 2 and Level 3 hypoglycemic events 55% versus placebo (p=0.000003).
- Avexitide holds FDA Breakthrough Therapy designation, supporting a potential 2027 launch if cleared.
