Catatan sumber primer
MaterialPermohonan diajukan
Annexon: tanruprubart MAA filing for GBS direncanakan Januari 2026
Dokumen menyatakan bahwa dossier tanruprubart GBS saat ini sedang berjalan sesuai rencana untuk pengajuan MAA pada Januari 2026. Diskusi berkelanjutan dengan FDA mengenai paket generalisasi untuk mendukung pengajuan BLA di masa depan juga dicatat. Tidak ada persetujuan, CRL, atau data topline yang dilaporkan.
Fakta utama
- Diajukan
- 10 Nov 2025, 21.08
- Peristiwa
- Permohonan diajukan
- Arah
- Netral
- Perusahaan
ANNXAnnexon- Aset
- tanruprubart
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
Kutipan sumber
EX-99.1 2 annx-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Annexon Reports Third Quarter 2025 Financial Results, Portfolio Progress and Key Anticipated Milestones Late-Stage Neuroinflammation Platform Advancing Global Registrational Programs in Guillain-Barré Syndrome (GBS) and Geographic Atrophy (GA) Current Tanruprubart GBS Dossier On Track for MAA Filing in January 2026; Potential to Be the First Approved Targeted and Fast-Acting Therapy for the Treatment of GBS; Continued FDA Discussions Regarding Generalizability Package in Support of BLA Filing Topline ARCHER II Pivotal Data for Vonaprument in Dry AMD with GA on Track for Second Half of 2026; Potential to Be the First Approved Vision Sparing Therapy for the Treatment of Eight Million GA Patients Worldwide ANX1502 Cold Agglutinin D