Inovio Pharmaceuticals, Inc. (INO) announced that its Biologics License Application for INO-3107, proposed for the treatment of adults with recurrent respiratory papillomatosis, has been accepted for review by the FDA.
The U.S. regulatory agency has assigned a PDUFA date of October 30, 2026, and indicated that it does not currently plan to convene an advisory committee meeting for the application.
INO-3107 is being reviewed under the accelerated approval pathway, although the FDA noted in its acceptance letter that additional information may be needed to justify eligibility for accelerated approval.
INOVIO said it plans to request a meeting with the agency to discuss next steps and remains confident that INO-3107 offers a meaningful therapeutic benefit for patients with this rare disease.
Recurrent respiratory papillomatosis (RRP) is a debilitating condition caused primarily by HPV-6 and HPV-11, characterized by the growth of benign papillomas in the respiratory tract that can obstruct the airway and impair speech. Surgery is the current standard of care, but papillomas frequently recur, often requiring repeated procedures that carry risks to vocal cord function and quality of life.
The BLA submission is supported by results from a Phase 1/2 trial in adults with RRP who had undergone at least two surgeries in the prior year.
In the study, 72% of patients experienced a 50-100% reduction in the number of surgeries during the first year after treatment with INO-3107. A retrospective follow-up analysis showed that 86% of evaluable patients maintained clinical benefits in the second year without additional dosing, with half requiring no surgeries at all. The data were published in Nature Communications and The Laryngoscope.
INO-3107 is designed to generate an antigen-specific T-cell response against HPV-6 and HPV-11, targeting infected cells to potentially prevent or slow papilloma growth.
The therapy was well tolerated in clinical testing, with mostly low-grade adverse events such as injection-site pain and fatigue.
In the U.S., INO-3107 carries the Orphan Drug and Breakthrough Therapy designations.
The company ended September 30, 2025, with cash, cash equivalents and short-term investments totaling $50.8 million, which is expected to be sufficient to fund operations into the second quarter of 2026.
Despite the FDA's acceptance of the BLA, shares declined as investors focused on the agency's indication that additional information may be required to support accelerated approval, introducing uncertainty around the regulatory timeline.
INO has traded between $1.3 and $2.98 over the past year. The stock is currently trading in the pre-market at $1.85, down 19.21%.
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