Annexon Phase 3 GBS trial meets primary endpoint; ANX005 shows 2.4-fold improvement on GBS-DS at week 8

Annexon, Inc.

Phase 3 trial met primary endpoint: single infusion of ANX005 30 mg/kg achieved 2.4-fold improvement on GBS-DS at week 8 (p=0.0058).
Key secondary endpoints met: 28 fewer days on ventilation (p=0.0356), 31-day reduction in time to walk independently (p=0.0211), and early muscle strength gains.
ANX005 was generally well-tolerated; most adverse events mild-to-moderate, no drug-related deaths or serious infections.
RWE comparability protocol initiated with IGOS; BLA submission and RWE data expected first half 2025.
GBS affects >22,000 hospitalized annually in U.S./Europe; no FDA-approved treatments currently.

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