other material
confidence high
sentiment positive
materiality 0.65
Annexon initiates Phase 3 ARCHER II GA trial; Phase 2 data show vision protection
Annexon, Inc.
- Dosing started in global pivotal Phase 3 ARCHER II trial of ANX007 for geographic atrophy (GA).
- Topline data expected in second half of 2026; trial to enroll ~630 patients.
- Phase 2 ARCHER: ANX007 reduced ≥15-letter BCVA loss to 5.6% vs sham 21.3% (p=0.0021).
- Structural protection: up to 60% photoreceptor preservation in central fovea (p=0.0319).
- FDA/EMA aligned on BCVA as primary endpoint; EU PRIME and US Fast Track designations.