原始来源记录
FDA 已接受 INO-3107 的 BLA 申请并纳入加速审批程序，目标 PDUFA 日期为 2026 年 10 月 30 日。该申请正在积极审查中，包括已完成中期审查会议。INOVIO 继续推进商业化准备工作，以应对 2026 年潜在获批。
EX-99.1 2 ino-33126x8kex991.htm EX-99.1 Document Exhibit 99.1 INOVIO Reports First Quarter 2026 Financial Results and Recent Business Highlights • Biologics License Application (BLA) for INO-3107 actively being reviewed under the accelerated approval program by the U.S. Food and Drug Administration (FDA) with a target Prescription Drug User Fee Act (PDUFA) date of October 30, 2026 • Commercial readiness plans continue to advance in anticipation of a potential commercial launch for INO-3107 as a treatment for adults with Recurrent Respiratory Papillomatosis (RRP) • Clinical trial collaboration and supply agreement announced with Akeso Inc. to evaluate INO-5412 in combination with cadonilimab for the potential treatment of glioblastoma (GBM) in a Dana-Farber Cancer Institute-sponsored tr