08:11 AM EDT, 06/04/2024 (MT Newswires) -- Annexon ( ANNX ) said Tuesday its Phase 3 trial evaluating investigational monoclonal antibody ANX005 in patients with the neurological disease Guillain-Barre syndrome met its primary endpoint and showed early and sustained improvements in key secondary endpoints.

Annexon ( ANNX ) said a single infusion of ANX005 at 30 mg/kg demonstrated a "highly statistically significant" 2.4-fold improvement on the GBS disability scale in the eighth week. The treatment also achieved early improvements in muscle strength, nerve damage and ventilation, which were the study's key secondary endpoints, according to the company.

Annexon ( ANNX ) said it expects to present real-world evidence comparability data and submit its biologics license application to the US Food and Drug Administration in the first half of 2025.

ANX005 was granted fast track and orphan drug designations by the FDA and an orphan drug designation by the European Medicines Agency, Annexon ( ANNX ) said.

Annexon ( ANNX ) shares climbed more than 25% in premarket activity Tuesday.

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