原始来源记录
INOVIO 已完成 INO-3107 的滚动 BLA 提交，寻求加速批准用于治疗成人复发性呼吸道乳头状瘤病。公司已申请优先审评，若获批准，文件受理后审评时限将为六个月。商业化上市准备工作正在进行中，若产品获批，预计可能于 2026 年年中上市。
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