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INOVIO menyelesaikan pengajuan BLA bergulir untuk INO-3107 yang mencari persetujuan dipercepat pada dewasa dengan papillomatosis respiratorik rekuren. Perusahaan meminta tinjauan prioritas, yang jika disetujui akan menetapkan jam tinjauan enam bulan setelah penerimaan berkas. Persiapan peluncuran komersial sedang berlangsung untuk peluncuran potensial pertengahan 2026 jika produk disetujui.
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