avexitide — NDA/BLA submission
Late 2026
By End of 2026 Anticipated additional term through commercial August 2026 Expected NDA Patent Term Extensions launch in 2027, submission to Announced positive if approved the FDASource filing
AMLX biotech catalysts & pipeline
AMYLYX PHARMACEUTICALS INC · Data as of 2026-10-25
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
avexitide — Conference presentation
Nov 15
Date and Time: Sunday, November 15, 2026, 8:30 a.m. – 8:45 a.m. ETSource filing