Shareholder Lawsuits Claim Inovio Pharmaceuticals Misstated CELLECTRA Manufacturing and INO‑3107 BLA Timelines

Lawsuits argue Inovio’s delivery device and timelines are materially misstated

Inovio Pharmaceuticals faces consolidated shareholder litigation alleging the company misled investors about manufacturing problems with its CELLECTRA delivery device and the regulatory prospects for its INO‑3107 biologics license application (BLA). Plaintiffs say public statements between Oct. 10, 2023 and Dec. 26, 2025 omit that CELLECTRA manufacturing is deficient and that, as a result, Inovio is unlikely to meet an asserted BLA filing window in the second half of 2024. The complaints contend those omissions render prior commentary on INO‑3107’s regulatory and commercial prospects materially false and misleading.

The filings stress that shortcomings in device manufacture could impede the submission and review of a BLA, and they specifically challenge assertions that Ino‑3107 had sufficient evidence to justify requests for FDA accelerated approval or priority review. For a biologic that relies on a proprietary delivery system, plaintiffs say, unresolved manufacturing issues with the delivery device create practical and regulatory barriers to demonstrating safety, efficacy and consistent product quality—elements the U.S. Food and Drug Administration requires for approval and for expedited pathways.

Industry observers say the litigation underscores the dependence of novel biologics on robust device manufacturing and regulatory documentation. If courts or regulators find merit in the allegations, Inovio could face not only legal exposure but also extended timelines for clinical validation, additional manufacturing remediation and more rigorous FDA scrutiny—factors that shape development strategy and commercial planning for companies that pair biologics with specialized delivery technologies.

Multiple plaintiff firms press claims; deadline looms

Several plaintiff firms, including Rosen Law Firm, The Schall Law Firm and DJS Law Group, are soliciting investors who bought Inovio securities in the stated class period to consider participating and to seek lead‑plaintiff status. The firms remind potential claimants that the deadline to move for lead plaintiff is April 7, 2026, and they offer contingency‑fee representation and no‑cost consultations to eligible investors.

The complaints remain at the pleading stage and the class is not yet certified; recovery will depend on class certification, proof of loss and court approval. The firms advise shareholders to preserve trade records and communications and to act promptly to protect their rights.