Business

Annexon Submits Tanruprubart Marketing Authorization Application to the European Medicines Agency for Guillain-Barré Syndrome

Potential to Be the First Targeted Fast-Acting Therapy for GBS, Setting a New Standard of Care BLA Submission with U.S./European Data from FORWARD Trial Planned in 2026 BRISBANE, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing the next generation platform of targeted immunotherapies aimed at neuroinflammatory diseases that impact nearly 10 million people worldwide, today announced it has submitted a Marketing Authorization Application

articleAnnexon, Inc.January 8, 20268/company/annexon-inc/news/annexon-submits-tanruprubart-marketing-authorization-130000056
Annexon Submits Tanruprubart Marketing Authorization Application to the European Medicines Agency for Guillain-Barré Syndrome

About this update from Annexon, Inc.

[{"type":"image","alt":"Annexon Biosciences","displaySize":"","headline":null,"caption":"Annexon Biosciences","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":99,"url":"https://media.zenfs.com/en/globenewswire.com/578fc108e7e0712a28769323578aa13e"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/5J35LGkHzjL3FW6lOBPAtA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEzOTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/578fc108e7e0712a28769323578aa13e","width":300,"height":99}},"lazy":false},{"type":"text","content":"Potential to Be the First Targeted Fast-Acting Therapy for GBS, Setting a New Standard of Care","length":94,"tagName":"p"},{"type":"text","content":" BLA Submission with U.S./European Data from FORWARD Trial Planned in 2026","length":73,"tagName":"p"},{"type":"text","content":"BRISBANE, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing the next generation platform of targeted immunotherapies aimed at neuroinflammatory diseases that impact nearly 10 million people worldwide, today announced it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for tanruprubart for the treatment of Guillain-Barré syndrome (GBS).","length":445,"tagName":"p"},{"type":"text","content":"“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.”","length":931,"tagName":"p"},{"type":"text","content":"GBS is an acute neuroinflammatory disease involving damage to peripheral ner...

More updates from Annexon, Inc.

nerve damageEuropean Medicines Agencyperipheral nervesFDAneuroinflammationbiopharmaceutical companyAnnexonapproved treatmentsdiseasedisease modifying therapies