Expired
Lead Plaintiff Deadline
Apr 7, 2026
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The filed complaint alleges that Inovio Pharmaceuticals, Inc made materially false and/or misleading statements and/or failed to disclose that: (i) manufacturing for Inovio’s CELLECTRA device was deficient; (ii) accordingly, Inovio was unlikely to submit it's lead product candidate, 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; (iv) accordingly, INO-3107’s overall regulatory and commercial prospects were overstated; and (v) as a result, defendants’ public statements were materially false and misleading at all relevant times.
In order to be eligible to join the INO class action lawsuit, you must have incurred a loss on shares of Inovio Pharmaceuticals, Inc. purchased during the class period listed above.
If you suffered a loss in Inovio Pharmaceuticals, Inc. during the relevant time frame or pursuant to the relevant offering(s), you have until April 7, 2026 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff.
A federal securities class action has been filed against Inovio Pharmaceuticals, Inc. (NASDAQ: INO), alleging violations of the Securities Exchange Act of 1934, including Sections 10(b) and 20(a) covering October 10, 2023 through December 26, 2025. Investors allege the company misrepresented the readiness of its CELLECTRA device, the timing of its INO-3107 Biologics License Application (BLA), and the drug's regulatory path, including the accelerated approval pathway of the U.S. Food and Drug Administration. During the period, Inovio repeatedly pointed to an accelerated approval route and a second-half 2024 BLA submission. The truth surfaced when the company disclosed a CELLECTRA manufacturing issue that pushed the filing into 2025 and later revealed the FDA had accepted the BLA, placing it on the standard review timeline and flagged inadequate information for accelerated approval. On these disclosures, Inovio's stock (NASDAQ: INO) fell on August 9, 2024 and again on December 29, 2025, harming investors.
“Most INO shareholders never file or join the class action, which means they miss out on potential recovery funds,” said Attorney Joseph Levi.
Case Name: Carlson v. Inovio Pharmaceuticals, Inc. et al.
Case No.: 2:26-cv-00803
Jurisdiction: U.S. District Court, Eastern District of Pennsylvania
Filed on: February 6, 2026
Inovio is a biotechnology company, publicly traded on the NASDAQ exchange developing DNA-based medicines for diseases associated with human papillomavirus (HPV) and other HPV-associated diseases. Its medicines use DNA plasmids and the company's proprietary investigational device, CELLECTRA electroporation device, to help deliver those plasmids into cells; the lead candidate is INO-3107 for recurrent respiratory papillomatosis (RRP), a rare condition.
October 10, 2023-December 26, 2025, inclusive.
All persons and entities other than Defendants that purchased or otherwise acquired Inovio securities, including common stock during the Class Period may be eligible to join the Inovio Pharmaceuticals, Inc. (INO) class action lawsuit.
According to the complaint, Inovio Pharmaceuticals, Inc., its President, Chief Executive Officer, and Director Jacqueline E. Shea, and its Chief Financial Officer Peter Kies are sued for statements about INO-3107's regulatory path and the company's device manufacturing, including alleged manufacturing deficiencies in the CELLECTRA device. The case centers on what they told investors about regulatory prospects and a near-term BLA submission, including use of the accelerated approval pathway and projected regulatory approval timing.
The story begins on October 10, 2023, when Inovio issued a press release stating it had received FDA feedback that data from the completed Phase 1/2 trial of INO-3107 "could support" a BLA under the accelerated approval program of the U.S. Food and Drug Administration. That same day, CEO Jacqueline Shea said the company would "focus[] on streamlining our development plan to support submission of a BLA for accelerated approval." As the narrative continued into the new year, on January 3, 2024, Shea told investors that, based on productive FDA discussions, Inovio believed it had "established a path" to submit a BLA under accelerated approval. Then on May 13, 2024, Inovio reiterated in another press release that it "remains on target to submit its BLA seeking accelerated approval for INO-3107 in the second half of 2024."
Meanwhile, the complaint alleges a different reality. Manufacturing for the CELLECTRA device was deficient, including a component deficiency, making a second-half 2024 BLA submission unlikely. The company also lacked sufficient information to justify accelerated approval or priority review, overstating INO-3107's regulatory and commercial prospects, under FDA standards for accelerated approval. As a result, investors allege these public statements were materially false and misleading, and maintained artificial stock price inflation during the class period.
The first break came on August 8, 2024, when Inovio disclosed in a press release and earnings call that it now expected to submit the INO-3107 BLA in mid-2025, approximately a one-year delay in the regulatory timeline, because of "a manufacturing issue" with the single-use disposable administration component of CELLECTRA, part of the CELLECTRA delivery system. CEO Jacqueline Shea acknowledged, "we've recently identified a manufacturing issue ... that we believe is resolvable, but will take additional time to rectify."
The second reveal landed on December 29, 2025, when Inovio announced the FDA had accepted the INO-3107 BLA for standard review (not accelerated approval). The company quoted the agency's file acceptance letter for the Biologics License Application noting a potential review issue: the FDA's preliminary conclusion that Inovio "has not submitted adequate information to justify eligibility for the accelerated approval pathway." These disclosures directly undercut prior assurances about both timing and accelerated approval prospects, placing INO-3107 on the standard review timeline.
Investors reacted as the disclosures hit. Following the August 8, 2024 announcement, Inovio's stock (NASDAQ: INO) fell $0.27, or 3.1%, to close at $8.44 on August 9, 2024, reflecting a disclosure-driven decline. After the December 29, 2025 news that the FDA had accepted the BLA for standard review and flagged inadequate information for accelerated approval, the stock dropped $0.56, or 24.45%, to close at $1.73 that same day.
The Court will issue its order for lead plaintiff and counsel in the weeks after submissions are due.
The Court will then consider motion for class certification.
The Court will later consider a Motion to Dismiss.
Disclaimer: This shareholder alert is for informational purposes only and does not constitute legal advice. Consult a qualified attorney for personalized guidance. No specific outcomes are guaranteed.
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