原始来源记录
FDA已接受INOVIO针对成人RRP的INO-3107 BLA加速批准申请。FDA将进行标准10个月审查，PDUFA目标行动日期为2026年10月30日。INOVIO申请了优先审评但获得的是标准审评；FDA还指出加速批准资格可能存在审查问题，并将在未来召开会议讨论。
EX-99.1 2 ino-123125x8kex991.htm EX-99.1 Document Exhibit 99.1 INOVIO Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Business Highlights • Biologics License Application (BLA) for INO-3107 accepted for review under the Accelerated Approval Program as a potential treatment for adults with Recurrent Respiratory Papillomatosis (RRP) by the U.S. Food and Drug Administration (FDA); target Prescription Drug User Fee Act (PDUFA ) date October 30, 2026 • INO-3107 immunological and long-term clinical and safety data published in Nature Communications and The Laryngoscope • Advanced promising next-generation DNA medicine technology: ◦ Phase 1 proof-of-concept trial of DNA-encoded Monoclonal Antibodies (DMAbs) published in Nature Medicine ◦ Promising preclinical data on nov