Vonaprument selected for EMA’s product development coordinator pilot

Published 07/08/2025, 21:46
Vonaprument selected for EMA’s product development coordinator pilot

BRISBANE, Calif. - Annexon, Inc. (NASDAQ:ANNX), a clinical-stage biopharmaceutical company with a current market capitalization of $260 million and a strong liquidity position according to InvestingPro data, announced Thursday that its eye treatment candidate vonaprument has been selected to participate in the European Medicines Agency’s (EMA) Product Development Coordinator (PDC) pilot program.

The PDC pilot, launched by the EMA in July 2025, aims to strengthen development support for promising treatments. Vonaprument is among approximately 20 Priority Medicine (PRIME) designation holders selected for the program. With the company’s current ratio of 7.99x, InvestingPro analysis shows Annexon maintains substantial liquidity to support its development programs.

Vonaprument is a non-pegylated antigen-binding fragment designed to block C1q locally in the eye through intravitreal administration. The treatment candidate is being developed for geographic atrophy (GA), an advanced form of dry age-related macular degeneration (AMD).

"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.

The drug candidate has received both PRIME designation in Europe and Fast Track Designation from the U.S. Food and Drug Administration. According to the company, vonaprument is the only investigational therapy in GA to demonstrate significant vision preservation on best corrected visual acuity and low luminance visual acuity endpoints.

Vonaprument is currently being evaluated in the ARCHER II trial, a global Phase 3 study that completed enrollment in July 2025. The trial has enrolled more than 630 patients with advanced dry AMD/geographic atrophy, with topline data expected in the second half of 2026.

Dry AMD affects an estimated eight million people globally, with geographic atrophy impacting approximately one million people in the United States alone.

This announcement was based on a company press release statement.

In other recent news, Annexon, Inc. has completed enrollment for its Phase 3 ARCHER II trial of vonaprument, a treatment for dry age-related macular degeneration with geographic atrophy. The trial exceeded its target with over 630 participants, and topline data is anticipated in the latter half of 2026. Additionally, Annexon announced amendments to its 2022 common stock purchase warrants, extending their term by one year to June 30, 2026, and stipulating cash-only transactions at a price of $5.806875 per share. Promising results were also reported from the Peripheral Nerve Society Annual Meeting, where Annexon’s lead therapy, tanruprubart, showed significant benefits for Guillain-Barré Syndrome, offering rapid and sustained recovery compared to standard treatments. Cantor Fitzgerald has maintained its Overweight rating on Annexon, citing the potential for stock appreciation contingent on the approval of ANX005 for Guillain-Barré Syndrome and positive safety and activity data for ANX1502 in Cold Agglutinin Disease. The analysts also noted the company’s robust financial position, with approximately $264 million in cash. These developments mark significant progress for Annexon in its clinical and financial endeavors.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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