Annexon Inc. has submitted a Marketing Authorization Application $(MAA)$ to the European Medicines Agency $(EMA)$ for tanruprubart, a potential first-in-class, targeted therapy for Guillain-Barré syndrome (GBS). This marks Annexon's first regulatory submission and could set a new standard of care for GBS, which currently has no approved disease-modifying therapies. The submission includes comprehensive data from two randomized, placebo-controlled studies showing significant improvement in patient outcomes. Annexon also plans to submit a Biologics License Application (BLA) to the FDA in 2026 with additional data from the ongoing FORWARD trial.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Annexon Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9622035-en) on January 08, 2026, and is solely responsible for the information contained therein.