Shock to the System: Inovio Sued Over CELLECTRA Issues and Inflated INO-3107 Outlook

Inovio told investors it was on the verge of history. A breakthrough DNA medicine. Accelerated FDA approval. A fast track to becoming a full commercial company. It sounded like a turning point.

Starting in October 2023, Inovio said the FDA agreed its Phase I/II data could support accelerated approval for INO-3107. In January 2024, executives promised a BLA filing by the second half of 2024. While promoting that regulatory path, the company raised capital through multiple stock offerings.

But in August 2024, the story cracked. Inovio admitted a manufacturing defect in its CELLECTRA device would delay the filing by about a year. The stock slipped.

Then in December 2025, the real blow landed. The FDA accepted the BLA but designated the review as standard, saying they had not submitted adequate information to justify eligibility for the accelerated approval pathway. Shares plunged about 24% in a single day.

Investors were stunned. Now, more shareholders are joining the lawsuit.