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New Pilot Appoints Designated Product Development Coordinator to Navigate Regulatory Interactions, Respond to Ad-hoc Queries, and Support Evidence Planning
Vonaprument Selected by EMA as One of ~20 PRIME Development Programs in the Pilot
Vonaprument Has the Potential to Be the First Treatment Approved in Europe and the U.S. for Dry AMD with Geographic Atrophy Based on Protection of Visual Acuity and Visual Structures
Annexon, Inc. (NASDAQ:ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today announced that the European Medicines Agency (EMA) has selected vonaprument (formerly ANX007) to participate in the Product Development Coordinator (PDC) pilot.
Vonaprument is a first-in-kind, non-pegylated antigen-binding fragment (Fab) that is designed to block C1q locally in the eye with an intravitreal formulation. It has received Priority Medicine (PRIME) designation in Europe and Fast Track Designation from the U.S. Food and Drug Administration (FDA) and is the only investigational therapy in geographic atrophy (GA) to show significant vision preservation on the endpoints of best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA).
The PDC pilot was launched by the EMA in July 2025 to strengthen stewardship through development support activities. With background and expertise in the therapeutic area of the product, the PDC is charged with helping PRIME designation holders efficiently navigate through various regulatory interactions, including expedited scientific advice, marketing authorization application (MAA) submission readiness activities and ad-hoc queries throughout the development program.
"We are honored that vonaprument has been selected by the EMA to participate in the PDC pilot. This selection reflects the EMA's commitment to fostering development support of vonaprument through faster, more flexible and expert-driven mechanisms," said AJ Acker, senior vice president of regulatory, quality and clinical safety at Annexon. "We value this opportunity to partner with the EMA in real time to help shape a strong and comprehensive submission. As a potential first-ever treatment for dry AMD with GA in Europe, we look forward to advancing vonaprument through this pilot toward registration."
Vonaprument is currently being evaluated in ARCHER II, a global, randomized, double-masked, sham-controlled pivotal Phase 3 trial designed to assess both visual acuity and structural measures to satisfy the global registration path in the U.S. and Europe. ARCHER II enrollment was completed in July 2025, and topline pivotal data is expected in the second half of 2026.
