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Annexon: pengajuan BLA tanruprubart diperkirakan Q4 2026

Dokumen menyatakan Annexon berencana mengajukan BLA untuk tanruprubart pada GBS di Q4 2026, didukung oleh data Fase 3, FORWARD open-label, dan bukti dunia nyata. Pengajuan akan mencakup data AS dan Eropa serta diposisikan sebagai tonggak regulasi berikutnya setelah MAA UE sudah dalam proses peninjauan.

Fakta utama

Diajukan
12 Agu 2026, 10.30
Peristiwa
Permohonan diajukan
Arah
Netral
Perusahaan
ANNXAnnexon
Aset
tanruprubart
Sumber
SEC 8-K
Keyakinan
Bersumber

Kutipan sumber

EX-99.1 2 d119960dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Annexon Reports Second Quarter 2026 Financial Results, Business Updates and Key Anticipated Milestones Rapid, Positive Clinical Outcomes in GBS FORWARD Study Reinforce Consistency and Reproducibility of Tanruprubart Treatment Effect Demonstrated in Phase 3 and Real-World Evidence Studies; BLA Submission Expected in Q4 2026 Vonaprument Phase 3 GA Program Expanded with Month 15 / 24 Dual Primary Endpoint Strategy and Launch of Open-Label Extension Study; Month 15 Primary Endpoint on Track for Q4 2026 POC Data for ANX1502, a First-in-Kind Oral C1 Inhibitor for Autoimmune Disease, Expected in Fall 2026 $200 Million Credit Facility Strengthens Balance Sheet and Capabilities; Anticipated Runway Extended into 2028 Company to Host Busin

SEC 8-K

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