EMA grants orphan drug designation to ANX005 for GBS; Phase 3 enrollment complete

Annexon, Inc.

European Medicines Agency granted orphan drug designation to ANX005 for Guillain-Barré Syndrome.
Target enrollment of 225 patients achieved in Phase 3 pivotal study of ANX005 in GBS.
Company on track to report topline Phase 3 data in first half of 2024.
EMA stated preliminary data show 'clinically relevant advantage' over intravenous immunoglobulin.
Orphan designation includes 10 years of EU market exclusivity and reduced regulatory fees.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.