The U.S. Food and Drug Administration (FDA) has accepted Inovio Pharmaceuticals Inc.'s Biologics License Application (BLA) for INO-3107, a potential treatment for adults with recurrent respiratory papillomatosis (RRP), for review. The FDA has set a Prescription Drug User Fee Act (PDUFA) review goal date of October 30, 2026. While the FDA noted concerns about the eligibility of INO-3107 for the accelerated approval pathway, Inovio maintains that the therapy offers meaningful benefits and plans to work with the FDA to address these concerns. The BLA submission is supported by clinical data demonstrating the therapy’s effectiveness and durability, offering a potential non-surgical treatment option for RRP patients. No advisory committee meeting is currently planned for this application.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Inovio Pharmaceuticals Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: PH54036) on December 29, 2025, and is solely responsible for the information contained therein.