What's Happening?
Faruqi & Faruqi, LLP, a national securities law firm, has announced a class action lawsuit against Inovio Pharmaceuticals, Inc. The lawsuit alleges that Inovio and its executives violated federal securities laws by making false or misleading statements and failing to disclose critical information. Specifically, the complaint claims that the manufacturing process for Inovio's CELLECTRA device was deficient, and that the company was unlikely to submit the Biologics License Application (BLA) for INO-3107 to the FDA by the second half of 2024. Furthermore, it is alleged that Inovio lacked sufficient information to justify the BLA's eligibility for FDA accelerated approval or priority review, leading to overstated regulatory and commercial prospects.
As a result of these issues, Inovio's stock price fell significantly on December 29, 2025, after the FDA accepted the BLA for standard review but not for accelerated approval.
Why It's Important?
This lawsuit is significant as it highlights potential regulatory and financial challenges faced by Inovio Pharmaceuticals, which could impact its market position and investor confidence. The allegations of misleading statements and inadequate disclosures could lead to financial penalties and damage the company's reputation. For investors, the outcome of this lawsuit could affect their financial interests, especially if the court rules in favor of the plaintiffs. The case also underscores the importance of transparency and compliance with regulatory standards in the pharmaceutical industry, which can have far-reaching implications for public health and safety.
What's Next?
The deadline for investors to seek the role of lead plaintiff in the class action is April 7, 2026. Inovio plans to request a meeting with the FDA to discuss the possibility of pursuing accelerated approval for INO-3107. The outcome of these discussions and the lawsuit could influence Inovio's future regulatory strategies and market performance. Investors and stakeholders will be closely monitoring these developments, as they could have significant implications for the company's financial health and strategic direction.
