---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-442648"
form_type: "8-K"
ticker: "INO"
cik: "0001055726"
company_name: "INOVIO PHARMACEUTICALS, INC."
filed_at: "2026-11-02T12:15:10+00:00"
generated_at: "2026-11-02T12:20:13.946830+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.92
calibrated_materiality_score: 0.92
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-26-442648
- form_type: 8-K
- ticker: INO
- cik: 0001055726
- company_name: INOVIO PHARMACEUTICALS, INC.
- filed_at: 2026-11-02T12:15:10+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.92
- calibrated_materiality_score: 0.92
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1055726/000119312526442648/0001193125-26-442648-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1055726/000119312526442648/d150457d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-442648
- JSON: https://secwatch.observer/filing/0001193125-26-442648.json
- Plain text: https://secwatch.observer/filing/0001193125-26-442648.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.