Annexon reports Q1 EPS (37c), consensus (29c)

“Our innovative C1 platform has yielded multiple wholly owned late-stage programs that have been shown to stop harmful neuroinflammation and lead to positive outcomes for patients across an array of diseases,” said Douglas Love, president and chief executive officer of Annexon (ANNX). “Our most advanced program, tanruprubart, is approaching filing for the treatment of Guillain-Barre Syndrome having consistently demonstrated rapid and sustained functional improvements in multiple placebo-controlled trials. Given the decades-long void of innovation, GBS remains a high unmet need without FDA-approved therapies or substantial evidence of effectiveness from the current standard of care, and we are eager to continue our dialogue with the FDA during our upcoming meeting this quarter in advance of our planned BLA submission. Furthermore, we are excited for the launch this quarter of the open-label FORWARD study designed to provide North American and European physicians and patients investigational access and experience with tanruprubart’s single infusion approach to tackling GBS. Our second late-stage asset, ANX007, is poised to be the first vision-preserving treatment for dry age-related macular degeneration with geographic atrophy globally, offering the potential to benefit more than eight million patients worldwide. With positive engagement by the retina community, we are on an accelerated pace to complete enrollment of the ongoing Phase 3 ARCHER II trial in the third quarter and deliver pivotal topline data in the second half of 2026. Finally, we anticipate completing the proof-of-concept trial for our oral small molecule ANX1502 in mid-2025, further characterizing its initial drug profile in patients with autoimmune disease. With continued strong strategic execution and runway into the second half of 2026, we are well-positioned to drive immense near to mid-term value and fulfill our mission of helping millions of patients live their best lives.”