Inovio Faces Securities Class Action Over INO-3107 BLA Delays and FDA Review Status
Multiple law firms have filed securities class actions against Inovio Pharmaceuticals after the FDA accepted its INO-3107 BLA for standard rather than accelerated review, following earlier manufacturing delays with the CELLECTRA device.
A securities class action has been filed on behalf of all persons who purchased or acquired Inovio Pharmaceuticals, Inc. (NASDAQ: INO) securities between October 10, 2023 and December 26, 2025. Inovio is a biotechnology company focused on the discovery, development, and commercialization of DNA medicines to treat and protect people from diseases associated with human papillomavirus ("HPV").
The complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose that: (1) manufacturing for Inovio's CELLECTRA device was deficient; (2) accordingly, Inovio was unlikely to submit the INO-3107 BLA to the FDA by the second half of 2024; (3) Inovio had insufficient information to justify the INO-3107 BLA's eligibility for FDA accelerated approval or priority review; (4) accordingly, INO-3107's overall regulatory and commercial prospects were overstated; and (5) as a result, public statements were materially false and misleading at all relevant times.
On August 8, 2024, after market hours, Inovio released its second quarter 2024 financial results, revealing that it expected to submit the Biologics License Application ("BLA") to the U.S. Food and Drug Administration for its recurrent respiratory papillomatosis treatment, INO-3107, in mid-2025, despite previous claims of a mid-2024 submission, due to a "manufacturing issue" with a component of the Company's proprietary investigational medical device, CELLECTRA. The expected submission represented an approximate full-year delay from the initially projected mid-2024 submission timeline. On this news, Inovio's stock price fell $0.27 per share, or 3.1%, to close at $8.44 per share on August 9, 2024.
On December 29, 2025, the U.S. Food and Drug Administration announced it had accepted Inovio's Biologics License Application for INO-3107 for standard review. Inovio disclosed that the FDA had accepted the INO-3107 BLA on a standard review timeline rather than the accelerated review timeline. The Company stated that it did not submit adequate information to justify eligibility for accelerated approval. The Company further stated that it does not plan to seek approval under the standard review timeline and would request a meeting with the FDA to discuss how it may still pursue accelerated approval. On this news, Inovio's stock price fell $0.56 per share, or 24.45%, to close at $1.73 per share on December 29, 2025.
The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Shareholders who wish to serve as lead plaintiff for the class must submit their papers to the court by April 7, 2026. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. The lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation. Shareholders do not have to participate in the case to be eligible for a recovery. If they choose to take no action, they can remain an absent class member. The ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not.