Case Summary
Inovio Pharmaceuticals
NASDAQ : INO
Case Details
- Carlson v. Inovio Pharmaceuticals, Inc. et al.
- Class Period:October 10, 2023 - December 26, 2025
- Date Filed:February 6, 2026
- Jurisdiction:U.S. District Court, Eastern District of Pennsylvania
- Docket Number: 2:26-cv-00803
- Lead Plaintiff Deadline: April 7, 2026
Seek Plaintiff 49
Overview
A class action lawsuit has been filed against Inovio Pharmaceuticals, Inc., (“Inovio,” or the “Company”) (NASDAQ : INO) and certain of the Company’s senior executive officers (collectively, “Defendants”) alleging violations of federal securities laws. The Inovio lawsuit is brought on behalf of all persons and entities who purchased or otherwise acquired Inovio between October 10, 2023, and December 26, 2025, both dates inclusive (the “Class Period”). Investors have until April 7, 2026, to seek appointment as lead plaintiff of the Inovio class action lawsuit.
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 asserts Defendants consistently and repeatedly indicated to investors that Inovio was rapidly approaching its transition into a commercial-stage company, one with a lead product asset that, once approved, would fill an unmet medical need and significantly improve the safety or effectiveness of current treatments for recurrent respiratory papillomatosis (“RRP”), a life-long, rare disease of the respiratory tract caused by HPV infection. Indeed, Defendants touted the prospects of the U.S. Food and Drug Administration (“FDA”) granting accelerated approval and/or priority review for the Biologics License Application (“BLA”) of INO-3107, the Company’s lead product candidate. Defendants also highlighted their ability to complete rolling submission of the INO-3107 BLA by the second half of 2024. While disseminating these positive statements, Defendants conducted numerous offerings of Inovio’s securities, reaping profits of tens of millions of dollars per offering.
Defendants’ statements misled shareholders regarding the Company’s business, operations, and prospects. Specifically, Inovio made false and/or misleading statements and/or failed to disclose that: (i) manufacturing for Inovio’s proprietary investigational medical device, “CELLECTRA,” which it uses to help its DNA medicines enter the body’s cells for purported optimal effect, was deficient; (ii) accordingly, Inovio was unlikely to submit the INO-3107 BLA to the FDA by the second half of 2024; (iii) Inovio had insufficient information to justify the INO-3107 BLA’s eligibility for FDA accelerated approval or priority review; and (iv) accordingly, INO-3107’s overall regulatory and commercial prospects were overstated.
The truth began to emerge on August 8, 2024, when Inovio reported its financial results for the second quarter of 2024. The Company revealed that Inovio expected to submit the INO-3107 BLA to the FDA in mid-2025—representing an approximate full-year delay from the Company’s initially projected mid-2024 submission timeline—because of “a manufacturing issue” with a component of the CELLECTRA device. On this news, Inovio’s stock price fell $0.27 per share, or 3%, to close at $8.44 per share on August 9, 2024.
The truth fully emerged on December 29, 2025, when Inovio issued a press release announcing that the FDA had accepted the INO-3107 BLA on a standard rather than accelerated review timeline. Inovio advised that the FDA had indicated that the Company did not submit adequate information to justify eligibility for accelerated approval. The Company further stated that Inovio 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 more than 24%, to close at $1.73 per share on December 29, 2025.
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If you purchased or otherwise acquired Inovio securities between October 10, 2023, and December 26, 2025, and you wish to serve as lead plaintiff in this lawsuit, you are encouraged to submit your information to DiCello Levitt LLP via the form on this page.
You can also contact DiCello Levitt attorneys Brian O’Mara or Hani Farah by calling (888) 287-9005 or at investors@dicellolevitt.com.
The deadline to apply to the Court to serve as a lead plaintiff in the Inovio lawsuit is April 7, 2026.