ANNX News & Events

Annexon highlighted its 2026 strategic priorities and key milestones for its lead programs. Key highlights include: Tanruprubart MAA Filed with Potential to Be the First Targeted Fast-Acting Therapy for Guillain-Barre Syndrome; BLA Submission with U.S./European Data Planned in 2026; Vonaprument Pivotal Phase 3 Topline Data for Dry AMD with Geographic Atrophy on Track for Second Half of 2026 Evaluating Unprecedented Effect on Vision Protection; Proof-of-Concept Data for ANX1502, the First Oral C1 Inhibitor for Autoimmune Disease, Expected in 2026

Annexon announced it has submitted a Marketing Authorization Application, MAA, to the European Medicines Agency, EMA, for tanruprubart for the treatment of Guillain-Barre syndrome, GBS. "Annexon's first regulatory submission marks a defining milestone for patients and for the company and represents the first of several important registrational catalysts anticipated from our lead programs in 2026," said Douglas Love, president and chief executive officer of Annexon. "In the landmark Phase 3 study, tanruprubart was shown to rapidly stop neuroinflammation, enabling GBS patients to recover faster and more completely from this sudden, life-threatening disease that has no approved disease modifying therapies. Accordingly, we look forward to working closely with the EMA during the review, and to further collaborating with regulatory authorities worldwide to make available the first targeted treatment for GBS. This submission is an important step on many fronts as we move closer to achieving our mission of helping millions of patients impacted by devastating neuroinflammatory diseases live their best lives."

Clear Street initiated coverage of Annexon with a Buy rating and $17 price target. In Phase 2 study, data from the company's lead asset vonaprument for geographic atrophy, GA, showed vision sparing, a critical differentiator the class, and the firm believes that strong pivotal data in the second half would provide key clinical de-risking and access to a large and growing market, the analyst tells investors in a research note. Investor pessimism around complement inhibitors for GA is contradicted by vonaprument's strong Phase 2 data, presenting a buying opportunity, Clear Street added.