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Annexon (ANNX) investor relations material
Annexon Cantor Global Healthcare Conference 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Company overview and therapeutic strategy
Focuses on the classical complement pathway, targeting the most upstream aspect (C1q) to address inflammatory diseases in the body, brain, and eye.
All programs are first-in-kind or pioneering, with consistent positive outcomes across flagship programs.
Three main programs: Guillain-Barré syndrome (GBS, most advanced), geographic atrophy (GA), and ANX-1502, a first-in-kind small molecule.
Clinical development and trial outcomes
GBS program completed a robust Phase III study ex-US, showing 90% of patients improved by week one, with significant reductions in ICU and ventilator time.
Shorter complement inhibition (30mg/kg) outperformed longer inhibition (75mg/kg), supporting limited inhibition for optimal recovery.
Real world evidence (RWE) study matched Phase III patients to a large natural history dataset, showing superior outcomes to IVIG on all key measures.
Regulatory and approval pathway
EMA and FDA require substantial Phase III evidence and demonstration of generalizability via RWE.
EMA has agreed on adequacy of studies and comparability analysis; rapporteur assigned and local meetings productive.
FDA discussions ongoing, with focus on generalizability policy for ex-US data; further meetings planned to clarify requirements.
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