Inovio Pharmaceuticals, Inc. ($INO) FDA Timeline & CELLECTRA Manufacturing Misstatements Case

Investors can submit applications for the lead plaintiff role.

E.D. Pennsylvania

Court

2:26-cv-00803

Case number

10/10/2023

Class period Start

12/26/2025

Class period End

04/07/2026

Lead Plaintiff motion deadline

$INO investors filed a claim against Inovio Pharmaceuticals, Inc. for allegedly misleading investors about the readiness of its CELLECTRA device manufacturing and the timing/likelihood of FDA accelerated approval (and priority review) for its lead candidate, INO-3107.
After the company disclosed a delay to its INO-3107 BLA tied to a CELLECTRA device manufacturing issue—and later revealed the FDA accepted the BLA under a standard (not accelerated) review timeline—$INO fell ~80.1% from $8.71 on August 8, 2024 to $1.73 on December 29, 2025.
$INO investors can join this case to be notified about potential recovery.
Case Details:

Between October 10, 2023 and December 26, 2025, Inovio told investors it was rapidly advancing INO-3107 (for recurrent respiratory papillomatosis) toward commercialization, including that it was on track to submit a BLA under the accelerated approval pathway (and request priority review). Executives emphasized FDA feedback and their ability to complete the submission on an aggressive timeline, reinforcing the company’s regulatory and commercial outlook.

However, during this period, investors allege Inovio faced undisclosed problems—particularly deficiencies tied to manufacturing for its proprietary CELLECTRA device—and lacked sufficient support to justify accelerated approval and/or priority review. Investors further allege Inovio failed to disclose these risks, overstating INO-3107’s regulatory and commercial prospects.

Then, on August 8, 2024, Inovio disclosed it now expected to submit the INO-3107 BLA in mid-2025 due to a manufacturing issue with a component of the CELLECTRA device. The stock fell about 3.1%, closing at $8.44 on August 9, 2024.

Additional revelations followed on December 29, 2025, when Inovio announced the FDA accepted the INO-3107 BLA on a standard review timeline and indicated the company had not provided adequate information to justify accelerated approval eligibility. Shares fell about 24.45%, closing at $1.73 on December 29, 2025.

Based on these events, $INO investors filed a claim against Inovio, alleging the company:
It concealed manufacturing deficiencies affecting its CELLECTRA device and readiness for submission
It misrepresented the BLA timeline and regulatory pathway, including eligibility for accelerated approval/priority review
It inflated $INO’s stock price by misleading investors about INO-3107’s regulatory and commercial prospects
Investors argue Inovio misled the market about the true status of its device manufacturing and the strength of its accelerated-approval case, causing losses when the truth emerged.

Case Type

US Securities Class Action

Case Status

Lead Plaintiff Submission

Alleged Offence

Misleading Statements,

Financial Misrepresentation,

Failure to Disclose,

Omissions

Suspected Party

Management

Security Type

Stocks

Trade Direction

Long

Shock Event Date

12/29/2025

Filing date

02/06/2026

Lead Plaintiff Deadline

04/07/2026

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