Inovio Pharmaceuticals continues to make significant progress toward FDA approval of INO-3107, forecasting a rolling submission for its Biologics License Application (BLA) within the year, supported by compelling efficacy data.

• Successful completion of design verification for the CELLECTRA 5PSP device enables next steps in regulatory milestones for INO-3107.
• The company plans to request a priority review of the BLA, potentially leading to a mid-2026 PDUFA date.
• Recent data highlight a sustained reduction in surgery rates for RRP patients treated with INO-3107, marking a significant clinical benefit.
• The FDA inspection of Inovio as the clinical sponsor has been completed successfully, crucial for ongoing regulatory assessments.
• Inovio is actively pursuing partnerships to advance its next-generation DNA medicine platforms, including dMAb and DPROT technologies.