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INOVIO nakumpleto ang rolling BLA submission para sa INO-3107 na humihiling ng accelerated approval sa mga adult na may recurrent respiratory papillomatosis. Hiniling ng kumpanya ang priority review, na kung ibibigay ay magtatakda ng anim na buwang review clock pagkatapos ng file acceptance. Kasalukuyang isinasagawa ang commercial launch preparations para sa potensyal na mid-2026 launch kung maaprubahan ang produkto.
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