INO Shares Plunge 24% Following FDA Review Setback Announcement by Inovio Pharmaceuticals

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) recently faced a substantial decline in its stock value, plummeting 24% after the FDA revealed that it had classified the company's review process for its Biologics License Application (BLA) as standard rather than accelerated. This shocking news hit the market on December 29, 2025, during pre-market hours and sent investors into a frenzy, leading to a significant drop of $0.56 per share, leaving it at a closing price of $1.73.

The legal firm Levi & Korsinsky, LLP, announced that they are representing investors in a pending class action lawsuit concerning potential misrepresentations by Inovio regarding their eligibility for accelerated regulatory pathways. This lawsuit is focused on a timeframe between October 10, 2023, and December 26, 2025, and investors have until April 7, 2026, to seek lead plaintiff status from the firm.

The market was particularly taken aback by the FDA's decision, which indicated that Inovio had failed to provide adequate information justifying accelerated approval. The stock was not only impacted by this revelation but had previously experienced a decline on August 9, 2024, when manufacturing delays were announced. Analysts began to downgrade their price targets following these disclosures, compounding the company's woes in the market.

In analyzing the implications of this FDA decision, prominent financial waste management firm H.C. Wainwright remarked that the 'accelerated review pathway is in dispute,' emphasizing the need for Inovio to overcome significant regulatory hurdles. Jefferies, another financial analysis firm, echoed these concerns, noting that the aftermath of the FDA's announcement caused the stock to plummet approximately 20%.

Legal experts assert that the issues raised by this legal action could indicate serious questions about whether investors received accurate and timely disclosures regarding Inovio's regulatory challenges. Joseph E. Levi, Esq., of Levi & Korsinsky, stated, "Our team is thoroughly investigating these claims and will ensure that investors are informed about their rights and options for potential compensation."

For impacted investors, options are available to recover losses without incurring out-of-pocket fees. Those interested in pursuing claims should reach out to Levi & Korsinsky to discuss the possibility of joining the class action. As the situation unfolds, it remains critical for Inovio to address these regulatory challenges and restore confidence among investors to stabilize its stock in a turbulent market. Analysts and investors alike will be monitoring the next steps closely as Inovio navigates these troubled waters in hopes of a more favorable outcome in the coming months.

Topics Financial Services & Investing)

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