Atara：已举行FDA会议；PFP计划重新提交tab-cel BLA

Pierre Fabre Pharmaceuticals与FDA举行了富有成效的会议，并获得同意，单臂研究配合历史对照即可支持上市申请。PFP计划在重新提交方案中提交包含更多患者和更长随访期的更新ALLELE数据集。Atara预计将在第三季度提供进一步的监管更新。

关键事实

申报时间: 2026年5月12日 20:10
事件: 申请已提交
方向: 中性
公司: ATRAAtara Biotherapeutics, Inc
资产: tabelecleucel
来源: SEC 8-K
可信度: 有来源

来源摘录

EX-99.1 2 atra-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Atara Biotherapeutics Announces First Quarter 2026 Financial Results and Operational Progress Productive meeting held with the FDA; planning for tabelecleucel BLA resubmission Operating efficiencies and ATM proceeds extend cash runway into mid-2027 THOUSAND OAKS, Calif.--(BUSINESS WIRE)-- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported financial results for the first quarter 2026 and business updates. Tabelecleucel (tab-cel ® or Ebvallo™) for Post-Transplant Lymphoproliferative Disease (PTLD) As previously communicated, Pierre Fabre

SEC 8-K