原始来源记录
重大申请已提交
Annexon：tanruprubart GBS MAA 申报计划于 2026 年 1 月提交
文件显示，目前 tanruprubart GBS 申报资料正按计划推进，MAA 申报定于 2026 年 1 月提交。同时提及正在与 FDA 就支持未来 BLA 申报的通用性资料包进行讨论。未报告任何批准、CRL 或顶线数据。
关键事实
- 申报时间
- 2025年11月10日 21:08
- 事件
- 申请已提交
- 方向
- 中性
- 来源
- SEC 8-K
- 可信度
- 有来源
来源摘录
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