FDA official announcements and press releases

Annexon Biosciences' ANX005 Meets Phase 3 Endpoint in GBS, Shares Surge Over 55%

Jun 4, 2024, 11:30 AM

Annexon Biosciences announced that its experimental drug, ANX005, met the primary endpoint in a Phase 3 trial for treating Guillain-Barré Syndrome (GBS). The trial showed a highly statistically significant 2.4-fold improvement in the GBS-DS endpoint at 8 weeks with a 30 mg/kg dose, compared to placebo (p=0.0058). However, the 75 mg/kg dose did not show statistical significance (p=0.5548). Following the announcement, Annexon's shares surged more than 31% before the bell, were up 55% in pre-market trading, and rose 48.0% pre-market. The company will discuss the Phase 3 data in a conference call and webcast on Tuesday, June 4, 2024, at 8:30 a.m. ET.