FDA has accepted Inovio Pharmaceuticals’ Biologics License Application for its DNA‑based therapy INO‑3107, a treatment for recurrent respiratory papillomatosis (RRP). The acceptance carries a Prescription Drug User Fee Act (PDUFA) review goal of October 30, 2026, and follows a Phase 1/2 study in which 81.3 % of adult patients saw a 50‑100 % reduction in surgical procedures during the first year and 86 % maintained that benefit in the second year without additional dosing.
While the acceptance is a regulatory milestone, the FDA has flagged a potential review issue concerning Inovio’s eligibility for accelerated approval. The company filed the BLA under the accelerated pathway, but the agency noted that the information submitted may not fully justify that designation. Inovio has scheduled a meeting with the FDA to address the concerns and clarify the data required for accelerated status.
The announcement was met with a negative market reaction, as investors weighed the uncertainty surrounding accelerated approval and the potential impact on the timing of commercial launch. The FDA’s caution signals that the company may need to provide additional evidence before the accelerated pathway can be granted.
Dr. Jacqueline Shea, Inovio’s CEO, said, “We believe there remains a critical unmet need among patients diagnosed with this rare and devastating disease and that every RRP patient deserves access to a non‑surgical treatment option that can work for them.” She added, “In clinical trials INO‑3107 demonstrated it has the potential to expand the treatment options for RRP patients, and we look forward to continuing to collaborate with the FDA during the BLA review cycle.”
The RRP market is estimated at roughly $1.2 billion in the United States, and INO‑3107’s success could position Inovio as the first DNA medicine approved in the U.S. The company’s market capitalization is about $157 million, and it holds more cash than debt, though it has a rapid cash burn and a negative cash return on invested capital. The BLA acceptance removes a key regulatory hurdle, but the accelerated‑approval uncertainty introduces a delay that could affect the company’s revenue timeline.
Inovio’s DNA platform, supported by its proprietary CELLECTRA delivery device, remains a unique technology that could extend beyond RRP if the therapy gains approval. The company’s next steps will involve addressing the FDA’s concerns, completing any additional data requirements, and preparing for a potential commercial launch that could unlock a sizable rare‑disease market.
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