一次情報の記録
FDAはINO-3107のBLAを標準審査で受理し、PDUFA目標日は2026年10月30日。FDAは加速承認の適格性に関する潜在的な問題を指摘; INOVIOはこれに対処するためミーティングを要請する予定で、従来の承認経路は追求しない。諮問委員会のミーティングは現時点で予定されていない。
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