A class action lawsuit has been filed against Inovio Pharmaceuticals, Inc., alleging the company made false and misleading statements regarding manufacturing deficiencies in its CELLECTRA device and overstated regulatory prospects for its INO-3107 candidate. The legal action follows the FDA's December 29, 2025 decision to reject the company's request for accelerated approval, instead accepting the Biologics License Application under the standard review pathway.
The FDA's decision represented a significant setback for the company's development timeline. The announcement triggered a sharp market reaction, with Inovio's stock declining 24.45% in response to the regulatory determination. The accelerated approval pathway would have enabled expedited market access for the treatment, whereas standard review typically requires a longer evaluation period.
The lawsuit contends that investors were not adequately informed about manufacturing challenges and the actual probability of regulatory approval at the accelerated pace. The case underscores ongoing scrutiny in the biotechnology sector regarding disclosure practices related to regulatory processes and manufacturing capabilities.