Annexon posts Q3 2026 results, flags tanruprubart BLA and ARCHER II readout timing

Annexon, Inc. reported third quarter 2026 results on November 9, 2026, alongside updates on its two late-stage programs.

For tanruprubart in Guillain-Barré syndrome, the company said an EU Marketing Authorisation Application is under review with the European Medicines Agency, supported by a data package meant to show rapid benefit on function and disability in patients with GBS.¹ In the open-label FORWARD study, 18 patients across the U.S. and Europe have been treated with tanruprubart to date, spanning moderate to severe disease in male and female patients aged 12 to 78.¹ Annexon said the study has shown functional outcomes, complete target engagement, and a generally well-tolerated safety profile, consistent with Phase 3 and real-world evidence data.¹ The company said the FORWARD findings bolster evidence that the treatment effect is consistent and reproducible across GBS patients who differ in disease neurotype, severity, age and geography,¹ ahead of a U.S. BLA submission expected in the fourth quarter of 2026.¹

For vonaprument in geographic atrophy, an independent Data Monitoring Committee will assess the Month 15 primary endpoint of the ARCHER II single study in the fourth quarter of 2026.¹ If the endpoint is met, the DMC will evaluate two pre-specified sub-studies, with results expected in the first quarter of 2027; otherwise the trial may continue to the Month 24 analysis.¹ Full ARCHER II completion, including Month 24 analyses, is expected in the third quarter of 2027.¹

On ANX1502, an oral C1s inhibitor, Annexon said a proof-of-concept study of an enteric-coated tablet in nine patients with cold agglutinin disease showed no significant safety signals,¹ with formulation optimization underway before studies in conditions such as generalized myasthenia gravis.¹

On financing, Annexon entered a credit facility with Oxford Finance LLC worth up to $200 million, drew $50 million at closing, and can access another $100 million tied to vonaprument and tanruprubart milestones, with the final $50 million subject to lender approval.¹ The company said cash, cash equivalents and short-term investments totaled $213.4 million as of September 30, 2026, expected to fund operations into 2028.¹