---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-332322"
form_type: "8-K"
ticker: "INO"
cik: "0001055726"
company_name: "INOVIO PHARMACEUTICALS, INC."
filed_at: "2025-12-29T23:59:59+00:00"
generated_at: "2026-05-16T12:03:58.301932+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-25-332322
- form_type: 8-K
- ticker: INO
- cik: 0001055726
- company_name: INOVIO PHARMACEUTICALS, INC.
- filed_at: 2025-12-29T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1055726/000119312525332322/0001193125-25-332322-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1055726/000119312525332322/d78035d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-332322
- JSON: https://secwatch.observer/filing/0001193125-25-332322.json
- Plain text: https://secwatch.observer/filing/0001193125-25-332322.txt

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