一次情報の記録
FDAは、RRPの成人患者を対象としたINO-3107のBLAをAccelerated Approval Programの下で受理した。審査期間は標準の10ヶ月で、PDUFAの目標アクション日は2026年10月30日。INOVIOは優先審査を要請したが標準審査となり、FDAはAccelerated Approvalの適格性に関する潜在的な審査課題を指摘し、今後の会議で協議する予定。
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