1차 출처 기록
FDA가 가속 승인 프로그램 하에 INO-3107의 BLA를 수락했으며, 2026년 10월 30일을 목표 PDUFA 날짜로 설정했습니다. 신청서는 중간 주기 심사 회의 완료를 포함하여 적극적으로 검토 중입니다. INOVIO는 2026년 잠재적 승인을 앞두고 상업적 준비 계획을 지속적으로 추진하고 있습니다.
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