---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-253450"
form_type: "8-K"
ticker: "INO"
cik: "0001055726"
company_name: "INOVIO PHARMACEUTICALS, INC."
filed_at: "2023-10-10T23:59:59+00:00"
generated_at: "2026-06-10T01:59:48.377628+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# INOVIO gets FDA nod to use Phase 1/2 data for INO-3107 BLA under accelerated approval; Phase 3 waived

## Summary
- FDA confirmed that completed Phase 1/2 trial data for INO-3107 in RRP can support BLA under accelerated approval; previously planned Phase 3 trial no longer required.
- Confirmatory trial must be initiated before BLA submission; design not yet finalized.
- If approved, INO-3107 would be first DNA medicine in the US and INOVIO's first commercial product.
- Phase 1/2 results: 81.3% (26/32) of patients had fewer surgical interventions; median reduction of 3 surgeries; strong T-cell immune response with durable memory.
- Cash runway guidance may change; company plans to provide updated cash guidance on Q3 2023 earnings call in November.

## SEC filing metadata
- accession: 0001193125-23-253450
- form_type: 8-K
- ticker: INO
- cik: 0001055726
- company_name: INOVIO PHARMACEUTICALS, INC.
- filed_at: 2023-10-10T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- 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/1055726/000119312523253450/0001193125-23-253450-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1055726/000119312523253450/d567242d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-253450
- JSON: https://secwatch.observer/filing/0001193125-23-253450.json
- Plain text: https://secwatch.observer/filing/0001193125-23-253450.txt

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