RegulatoryCompany release

Annexon plans US filing for tanruprubart in Q4 as EMA reviews Guillain-Barré drug

🇺🇸 Annexon, Inc. (ANNX) · Mon 09 Nov 2026

Annexon's third-quarter update says its C1q inhibitor is under EMA review, a US BLA is due in Q4 2026, and ARCHER II's Month 15 primary endpoint is nearing assessment.

Annexon reported its third-quarter 2026 results on 9 November, setting out regulatory and clinical milestones for the final months of the year. The company's C1q inhibitor tanruprubart, developed for Guillain-Barré syndrome, is currently under review by the European Medicines Agency.

In the United States, Annexon expects to submit a Biologics License Application (BLA) for tanruprubart in the fourth quarter of 2026. The summary of the update does not give a precise submission date or details of the data package.

The company also expects its Data Monitoring Committee to assess the Month 15 primary endpoint of ARCHER II in the fourth quarter. ARCHER II is a Phase 3 trial of vonaprument in geographic atrophy.

On finances, Annexon reported $213.4 million in cash and said this gives it a runway into 2028. It also disclosed a credit facility of up to $200 million with Oxford Finance.

What it means for your team

  • Regulatory teams tracking Guillain-Barré therapies should note that tanruprubart is under EMA review, with a US BLA expected before the end of 2026.
  • Market-access planners may want to watch for the BLA submission and the EMA outcome, as neither timeline is detailed in the update.
  • The Month 15 ARCHER II assessment in geographic atrophy is a Q4 2026 milestone for anyone following that indication.

Company's press release (SEC filing): Annexon, Inc. ↗

Article written by VigiEye from the official source (Annexon, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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