1차 출처 기록
FDA가 INOVIO의 INO-3107 BLA를 표준 심사로 수리했으며, PDUFA 목표일은 2026년 10월 30일입니다. FDA는 가속승인 적격성에 잠재적 문제가 있음을 지적했으며, INOVIO는 이를 논의하기 위한 회의 요청을 계획 중이며 전통적 승인 경로는 추구하지 않고 있습니다. 현재 자문위원회 회의는 예정되어 있지 않습니다.
EX-99.1 2 d78035dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 FDA Accepts for Review INOVIO’s BLA for INO-3107 for the Treatment of Adults with Recurrent Respiratory Papillomatosis (RRP) PLYMOUTH MEETING, PA., December 29, 2025 /PRNewswire/ — INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted the company’s Biologics License Application (BLA) for INO-3107 for review as a potential treatment for adults with RRP. The review classification designated by FDA is Standard. The FDA assigned INO-3107 a Prescription Drug User Fee Act (PDUFA) review goal date of October 30, 2026, which