Isophoric News · Tuesday, November 3, 2026
FDA grants accelerated approval to Inovio's Voceryq for adults with recurrent respiratory papillomatosis
The Food and Drug Administration granted accelerated approval on Friday, Oct. 30, to Voceryq, an Inovio Pharmaceuticals immunotherapy for adults with recurrent respiratory papillomatosis, a rare disease in which human papillomavirus causes wart-like growths in the airways. The FDA said it is the first plasmid DNA-based immunotherapy approved in the United States. The agency based the decision on trial data showing the therapy reduced how often patients needed surgery to remove the growths, an intermediate endpoint that it said is "reasonably likely to predict clinical benefit." It said the manufacturer must conduct post-approval clinical trials to verify and describe that benefit.
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The open-label trial enrolled 32 adults who had needed two or more surgeries in the prior 12 months, the FDA said. Of 26 patients who had at least three surgeries before treatment, seven, or 27%, needed no surgery in the first year afterward. MedPage Today reported that treatment begins with surgery to remove visible growths, followed by four intramuscular doses three weeks apart, given with Inovio's CELLECTRA 5PSP device, which the FDA said uses brief electrical pulses to deliver the therapy into cells. The most common adverse reactions included injection site reactions, headache, fatigue, high blood pressure, nausea and dizziness, according to the FDA.
Inovio set a list price of $115,000 per dose, or $460,000 for the four-dose series, which its chief commercial officer said is consistent with Precigen's Papzimeos, approved in 2025 as the first drug for the disease, MedCity News reported. The company expects Voceryq to be available within 60 days and said it is funded for the launch into the first quarter of 2027 but will need more capital, according to MedCity News.