Early Outcomes Reinforce the Consistency and Reproducibility of Tanruprubart Treatment Effect Previously Demonstrated in Phase 3 and Real-World Evidence Studies 

Potential to Become the First Approved Targeted Therapy to Treat GBS Worldwide, Addressing the Significant Unmet Need and Over $20 Billion Estimated Annual U.S. Healthcare Burden

FORWARD Data to Support BLA Submission Targeted for Q4 2026; Tanruprubart Currently Under Review by the EMA

BRISBANE, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Annexon, Inc. (NASDAQ:ANNX), a biopharmaceutical company advancing the next generation platform of targeted immunotherapies for multiple neuroinflammatory diseases that impact nearly 10 million people worldwide, today announced early improvement in strength and clinically meaningful reduction in disability shown with tanruprubart in the first ten U.S. and European patients with Guillain-Barré syndrome (GBS) from its ongoing, open-label FORWARD study.

GBS is a life-threatening neuroinflammatory disease that can cause rapid and severe weakness or complete paralysis, often requiring intensive care and mechanical ventilation. It is the leading cause of acute neuromuscular paralysis with approximately 22,000 patients affected annually across the U.S. and Europe, and an estimated >$20 billion annual healthcare burden in the U.S. alone. In the 110 years since GBS was described, there have been no approved targeted therapies that rapidly and meaningfully impact the disease. Current standard-of-care intravenous immunoglobulin (IVIg), which is not FDA-approved, provides incomplete benefit for many patients. Indeed, despite standard of care use, mortality rates associated with GBS are up to 10%1 generally, and nearly 25% in GBS patients over the age of 65 within one year of hospitalization. Moreover, many IVIg-treated patients frequently progress during or shortly after treatment, resulting in ventilatory support in one of four patients, prolonged intensive care unit (ICU) stays, inability to walk unassisted for months to years, and continued physical and psychological limitations, pain and severe fatigue.