Inovio Faces Class Action Over Manufacturing Deficiencies and Regulatory Delays
Inovio Pharmaceuticals faces a class action lawsuit alleging false statements about manufacturing deficiencies affecting its INO-3107 drug candidate. The lawsuit claims the company exaggerated its ability to file a BLA by mid-2024 and misled investors about accelerated FDA review prospects. Following FDA acceptance for standard rather than accelerated review, Inovio's stock dropped 24.45%.
A class action lawsuit has been filed against Inovio Pharmaceuticals alleging the company made false and misleading statements about manufacturing deficiencies and regulatory prospects for its lead drug candidate INO-3107. The lawsuit, initiated on March 19, 2026, accuses senior management of misleading investors about the production and regulatory progress of INO-3107 over a two-year span ending in late 2025, with investors having until April 7, 2026, to join the suit.
The lawsuit alleges that Inovio exaggerated its ability to file a Biologics License Application (BLA) by mid-2024 and its chances for expedited FDA review, all while raising substantial funds through secondary stock offerings. The central claim targets the company's critical timeline, alleging that production of the CELLECTRA device was inadequate, which is cited as the main reason Inovio failed to submit the INO-3107 BLA to the FDA by the second half of 2024.
The turning point occurred on December 29, 2025, when Inovio announced the FDA had accepted the INO-3107 BLA for standard review, not the accelerated approval previously promised. The company admitted it lacked sufficient data to qualify for expedited review. Following this news, shares dropped 24.45%, closing at $1.73 per share, with the stock trading at $1.58 as of March 22, 2026.
This manufacturing deficiency poses an immediate threat to the drug's regulatory path. The lawsuit asserts that, due to these shortcomings, Inovio lacked the necessary information to qualify INO-3107 for FDA accelerated approval or priority review. The FDA echoed this concern in its acceptance letter, highlighting a potential issue with accelerated approval eligibility and scheduling a meeting to determine whether the company can still pursue expedited review for the October 30, 2026 PDUFA date.
Inovio's financial position is precarious. The company reported $58.5 million in cash at the end of Q4 2025, with management estimating this will last through the fourth quarter of 2026. With a net loss of $84.9 million for 2025—nearly $21 million spent per quarter—any further regulatory delays would intensify cash burn and risk.
The class action covers investors who purchased securities between October 10, 2023, and December 26, 2025, with a deadline of April 7, 2026, to apply as lead plaintiffs. The lawsuit alleges that Inovio made false and misleading statements during the class period, failing to disclose deficiencies in the manufacturing of its CELLECTRA device, which impacted the likelihood of timely submission of the INO-3107 Biologics License Application, thereby misleading investors.
INO-3107 is Inovio's lead candidate for the treatment of recurrent respiratory papillomatosis (RRP), a chronic, rare and debilitating disease caused by HPV-6 and HPV-11. The company's proprietary investigational CELLECTRA devices are designed to deliver plasmids into the body's cells without the use of chemical adjuvants, lipid nanoparticles or viral vectors.