ANNX Annexon

tanruprubart · NCT07020819 registry update

countries: {'total_sites': 28, 'us_sites': 20} → {'total_sites': 30, 'us_sites': 22}

vonaprument · NCT04656561 registry update

primary_outcomes: ['GA lesion growth rate'] → ['Rate of Change (Slope) From Baseline to Month 12 in GA Lesion Area']

tanruprubart · NCT07020819 registry update

primary_completion: 2026-12-31 → 2027-05-31; countries: {'total_sites': 13, 'us_sites': 12} → {'total_sites': 28, 'us_sites': 20}

vonaprument · NCT06510816 registry update

primary_completion: 2026-10-31 → 2027-07-31; primary_outcomes: ['Proportion of Participants Experiencing a Best Corrected Visual Acuity (BCVA) ≥15-letter Loss from Baseline Through Month 15 as Assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Any Two Consecutive Visits'] → ['Proportion of Participants Experiencing a Best Corrected Visual Acuity (BCVA) ≥15-letter Loss from Baseline Through Month 15 as Assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Any Two Consecutive Visits', 'Proportion of Participants Experiencing a BCVA ≥15-letter Loss from Baseline Through Month 24 as Assessed by the ETDRS Chart at Any Two Consecutive Visits']

Annexon: tanruprubart BLA submission expected Q4 2026

The document states Annexon plans to submit a BLA for tanruprubart in GBS in Q4 2026, supported by Phase 3, FORWARD open-label, and real-world evidence data. The filing will include both U.S. and European data and is positioned as the next regulatory milestone after the EU MAA is already under review.

Annexon: FORWARD GBS study shows rapid tanruprubart responses in first 10 patients

First U.S./EU cohort (n=10) of the open-label FORWARD study demonstrated clinically meaningful strength gains and reduced disability within days of a single 30 mg/kg dose. All patients improved within four days, four bedbound patients walked by day 8, and one ventilated patient was extubated within four days. Data will support the planned BLA submission targeted for Q4 2026.

Annexon, Inc. Secures $200 Million Credit Facility from Oxford Finance

Annexon, Inc. has entered into a strategic credit facility agreement with Oxford Finance LLC for up to $200 million. An initial $50 million was drawn at closing, with an additional $100 million available upon achievement of certain milestones related to its vonaprument and tanruprubart registrational programs. This financing aims to enhance financial capacity for potential global commercialization of these assets.

Annexon: ARCHER II Phase 3 topline data for vonaprument in GA expected Q4 2026

The company announced that topline pivotal Phase 3 data from the ARCHER II trial of vonaprument in geographic atrophy are now expected in Q4 2026. This readout is the next major regulatory/clinical milestone for the asset and is intended to support global registration.

Annexon: ARCHER II Phase 3 vonaprument data expected 2026

The January 2026 J.P. Morgan presentation confirms ARCHER II Phase 3 pivotal data for vonaprument (ANX007) in dry AMD with GA is the key 2026 catalyst. The company positions this readout as one of two blockbuster registrational opportunities alongside tanruprubart in GBS, with cash runway into late 2027.

Annexon: tanruprubart MAA filing for GBS planned January 2026

The document states the current tanruprubart GBS dossier is on track for MAA filing in January 2026. Ongoing FDA discussions on the generalizability package to support a future BLA submission are also noted. No approval, CRL, or topline data are reported.