原始出處紀錄
重大申請已送件
Annexon：tanruprubart GBS 之 MAA 申請預計於 2026 年 1 月提交
文件指出，目前 tanruprubart GBS 檔案正按計畫於 2026 年 1 月提交 MAA。亦提及 FDA 持續討論通用性套件，以支持未來的 BLA 提交。未報告任何核准、CRL 或頂線數據。
關鍵事實
- 申報時間
- 2025年11月10日 下午09:08
- 事件
- 申請已送件
- 方向
- 中性
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
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