FDA approves Inovio's Voceryq, first DNA immunotherapy for adults with recurrent respiratory papillomatosis

The Food and Drug Administration granted accelerated approval on October 30 to Voceryq, a DNA-based immunotherapy from Inovio Pharmaceuticals for adults with recurrent respiratory papillomatosis, a rare HPV-driven disease that grows wart-like tumors in the airway. The agency said it is the first plasmid DNA-based immunotherapy approved in the United States.

Patients with the disease, known as RRP, typically need repeated surgeries to clear growths around the larynx and vocal cords. There is no cure, and the virus stays in the tissue after each operation. Voceryq is given by intramuscular injection with a device called CELLECTRA 5PSP, which uses brief electrical pulses to help cells take up the DNA.

The approval rests on one open-label trial of 32 adults with no control group. Among 26 patients who had at least three surgeries in the year before treatment, 7 (27 percent) needed no surgery during the first year after treatment, according to the FDA. HCP Live reported a 95 percent confidence interval of 12 to 48 percent.

The most common side effects were injection site reactions, headache, fatigue, high blood pressure, nausea and dizziness. The FDA also listed effects tied to the electrical pulses, including brief muscle contractions, temporary bleeding at the injection site and fainting-type reactions.

Accelerated approval means the benefit is not yet confirmed. Inovio must run further trials, and HCP Live reported the company plans to send the FDA a draft protocol by the end of 2026. Ordering is expected to open about 60 days after approval, with a full commercial rollout in the first quarter of 2027. Neither source reports a price.

Voceryq arrives a little over a year after the FDA approved Papzimeos, a different RRP immunotherapy built on an adenoviral vector, on August 14, 2025.