Inovio Pharmaceuticals, Inc. announced plans to submit a BLA for INO-3107 as a potential treatment for Recurrent Respiratory Papillomatosis (RRP) in the second half of 2024. This announcement follows an Initial Comprehensive Multidisciplinary Breakthrough Therapy (Type B) Meeting with the FDA on critical aspects of the data package required to submit a BLA under the agency's accelerated approval program. A Priority Review, if granted, could shorten the FDA's review of the BLA to approximately six months from the time of the submission being accepted, as compared to a standard review timeline of approximately 10 months.

If approved, INO-3107 would be the first DNA medicine made available to RRP patients in the United States and INOVIO's first approved product. The FDA previously granted INO-3107 Orphan Drug designation and Breakthrough Therapy designation, and advised INOVIO that it could submit its BLA under the accelerated approval program using data from its already completed Phase 1/2 trial. The European Commission has also granted INO-3107 Orphan Drug designation.

INOVIO's delivery device, CELLECTRA®, received CE marking, a regulatory standard that certifies that a product has met European Union's safety, health, and environmental standards.