On Monday, November 3 2025, Inovio Pharmaceuticals announced that it had completed the rolling submission of its Biologics License Application (BLA) for INO‑3107, a DNA immunotherapy designed to treat recurrent respiratory papillomatosis (RRP) in adults. The filing was made under the FDA’s Accelerated Approval program and includes a request for priority review, which could lead to acceptance within six months after the 60‑day filing period.
The submission marks the first BLA filing for Inovio and the first step toward the company’s goal of launching its first commercial product. If the FDA grants priority review, the company expects the BLA to be accepted by the end of 2025, with a potential PDUFA date in mid‑2026. INO‑3107 has already received orphan drug and breakthrough therapy designations, positioning it for a streamlined regulatory pathway.
This milestone is significant for Inovio’s commercial strategy. Completing the BLA moves the company from clinical development into the regulatory approval phase, potentially unlocking the first revenue stream and establishing a first‑in‑class DNA medicine in the U.S. market. The filing also signals progress toward the company’s broader goal of transitioning from a clinical‑stage biotechnology firm to a commercial entity, with implications for future funding, partnerships, and market positioning.
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