Annexon Reports Third Quarter 2025 Financial Results, Portfolio Progress and Key Anticipated Milestones

Core Insights - Annexon, Inc. is advancing its late-stage neuroinflammation platform with significant milestones expected in 2026, including the potential approval of targeted therapies for Guillain-Barré Syndrome (GBS) and Geographic Atrophy (GA) [1][2][3] GBS Program - The company is on track to submit a Marketing Authorisation Application (MAA) for Tanruprubart in GBS by January 2026, aiming to be the first approved targeted therapy for this condition, which affects approximately 150,000 people annually worldwide [2][3] - Ongoing discussions with the FDA are focused on the generalizability package to support the Biologics License Application (BLA) submission [2][3] GA Program - The Phase 3 trial for Vonaprument in GA is expected to deliver topline data in the second half of 2026, with the potential to be the first approved vision-sparing therapy for the eight million patients affected by GA globally [1][2][4] - The ARCHER II trial has completed enrollment with 659 GA patients, exceeding targets, and is designed to evaluate visual function as the primary endpoint [7] ANX1502 Program - ANX1502 is an oral C1s inhibitor currently in a proof-of-concept study for Cold Agglutinin Disease (CAD), with completion expected in 2026 [1][5][7] - The program aims to provide a convenient oral treatment option for multiple neuroinflammatory autoimmune diseases [5] Financial Position - As of September 30, 2025, the company reported cash and cash equivalents of $188.7 million, extending its operational runway into late Q1 2027 [7][8] - Research and development expenses increased to $49.7 million for Q3 2025, primarily due to advancements in the Phase 3 ARCHER II trial and global filings for Tanruprubart [8][13]