Inovio wins FDA accelerated approval of VOCERYQ, first U.S.-approved DNA medicine, for RRP

INOVIO PHARMACEUTICALS, INC.

• FDA granted accelerated approval for VOCERYQ (formerly INO-3107) to reduce frequency of surgery in adults with recurrent respiratory papillomatosis (RRP).
• Pivotal RRP-001: 7 of 26 efficacy patients (27%, 95% CI 12-48%) had complete response — no surgical excision 12 months after treatment; median 4.5 prior surgeries.
• Inovio expects VOCERYQ to be orderable and shipping in about 60 days, with full field deployment in Q1 2027; Syneos Health engaged for commercial and medical field teams.
• Confirmatory study required: draft protocol due to FDA by end of 2026, final protocol alignment expected mid-2027; continued approval contingent on verifying clinical benefit.
• Inovio cites a prevalent U.S. RRP population of at least 25,000; VOCERYQ approved in combination with the CELLECTRA 5PSP delivery device.