FDA accepts INOVIO's BLA for INO-3107; standard review, PDUFA Oct 2026, but flags accelerated approval issue

INOVIO PHARMACEUTICALS, INC.

BLA accepted for review; FDA classified as standard; no advisory committee planned.
PDUFA goal date October 30, 2026.
FDA preliminary conclusion: inadequate info to justify accelerated approval eligibility.
Company to request meeting with FDA to discuss accelerated approval; not pursuing traditional pathway.
INO-3107 is investigational immunotherapy for recurrent respiratory papillomatosis (RRP) in adults.

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