一次情報の記録
FDAはINO-3107のBLAを加速承認プログラムの下で受理し、PDUFA目標日を2026年10月30日と設定した。申請は中間審査会議の完了を含む積極的な審査中である。INOVIOは2026年の承認の可能性に備え、商業化準備計画を継続して進めている。
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