Amyotrophic Lateral Sclerosis (ALS)Delivered 2026-04-21

Relyvrio: FDA Regulatory Timeline

IND 129563 — Amylyx Pharmaceuticals

22 FDA regulatory interactions for AMX0035 (Relyvrio) spanning March 2016 through July 2021, covering IND submission, Fast Track denials, BTD denial, and pre-NDA planning.

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