Atara：FDA會議已舉行；PFP計劃重新提交tab-cel BLA

Pierre Fabre Pharmaceuticals與FDA舉行了一次富有成效的會議，並獲得同意單臂研究搭配歷史對照即可支持上市申請。PFP計劃在重新提交方案中提交包含更多患者及更長追蹤期的更新後ALLELE數據集。Atara預計將在第三季提供進一步的法規更新。

關鍵事實

申報時間: 2026年5月12日下午08:10
事件: 申請已送件
方向: 中性
公司: ATRAAtara Biotherapeutics, Inc
資產: tabelecleucel
來源: SEC 8-K
可信度: 有出處

來源摘錄

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