Inovio Stock Sinks As FDA Pushes Back On Accelerated Approval For Rare Disease Drug

Inovio Pharmaceuticals Inc. (NASDAQ:INO) stock fell Monday after the U.S. Food and Drug Administration accepted the company’s Biologics License Application (BLA) for INO-3107 but raised concerns tied to the accelerated approval pathway.

The biotechnology company focused on developing and commercializing DNA medicines said that the FDA accepted the company’s BLA for INO-3107 for review as a potential treatment for adults with Recurrent Respiratory Papillomatosis (RRP). The review classification designated by the FDA is Standard.

RRP is a rare, benign (noncancerous) disease caused by the Human Papillomavirus, leading to wart-like tumors in the respiratory tract, most commonly the larynx (voice box).

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PDUFA Timeline And Advisory Panel Update

The FDA assigned INO-3107 a Prescription Drug User Fee Act (PDUFA) review goal date of October 30, 2026.

The FDA has indicated that it is not currently planning to hold an advisory committee meeting to discuss this application.

Inovio filed its BLA under the accelerated approval pathway.

The FDA, in the file acceptance letter, noted as a potential review issue its preliminary conclusion that the company has not submitted adequate information to justify eligibility for the accelerated approval pathway.

Company Response And Next Steps

Inovio continues to believe that INO-3107 provides a meaningful therapeutic benefit over existing treatments and fulfills the criteria for accelerated approval.

Inovio plans to request a meeting with the FDA to discuss the next steps to remain eligible under the accelerated approval program.

Inovio is not currently planning to seek approval for INO-3107 under the traditional pathway.

The BLA is supported by data from a Phase 1/2 trial evaluating INO-3107 in adult patients with RRP who had two or more surgeries in the year prior to treatment.

Long-term durability data from a retrospective trial of the original trial participants were also included in the BLA filing, demonstrating that the majority of evaluable patients continued to see clinical benefit in the second twelve-month period after treatment, without additional dosing.

INO Price Action: Inovio Pharmaceuticals shares were down 24.38% at $1.73 at the time of publication on Monday, according to Benzinga Pro data.

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