avexitide — NDA/BLA submission
by year-end
Amylyx plans to submit an NDA for avexitide with the FDA by year-end; avexitide has Breakthrough Therapy and Orphan Drug Designations by the FDASource filing
AMLX biotech catalysts & pipeline
AMYLYX PHARMACEUTICALS INC · Data as of 2026-09-08
Upcoming catalysts
AMX0318 — IND submission
2027
Investigational New Drug (IND)-enabling studies for AMX0318, a novel GLP-1 receptor antagonist for long-acting administration to treat PBH and other rare diseases, are underway with an IND filing targeted for 2027.Source filing