一次情報の記録
INOVIOは、再発性呼吸器乳頭腫症の成人患者を対象としたINO-3107の加速承認取得を目指し、ローリングBLA提出を完了しました。同社は優先審査を要請しており、受理されれば提出受理後6ヶ月間の審査期間が設定されます。承認された場合、2026年半ばの発売を想定し、商業化に向けた準備が進められています。
EX-99.1 2 ino-93025x8kex991.htm EX-99.1 Document Exhibit 99.1 INOVIO Reports Third Quarter 2025 Financial Results and Recent Business Highlights • Completed rolling Biologics License Application (BLA) submission seeking accelerated approval for lead candidate INO-3107; requested priority review • Expect to receive file acceptance by year end 2025 with potential PDUFA date in mid-2026 if request for priority review granted • Commercial preparations continuing for potential launch in mid-2026 if INO-3107 is approved by FDA • Results from Phase 1 proof-of-concept trial evaluating INOVIO’s next generation DNA-Encoded Monoclonal Antibody (DMAb TM ) technology published in Nature Medicine PLYMOUTH MEETING, PA – November 10, 2025 – INOVIO (NASDAQ: INO), a biotechnology company focused on dev