FDA approves Voceryq, first plasmid DNA immunotherapy

The FDA on Oct. 30 granted accelerated approval to Voceryq, the first plasmid DNA based immunotherapy approved in the U.S. In its trial, 7 of 26 adults (27%) who had at least three prior surgeries needed no surgery in the year after treatment, the FDA said.

Voceryq is made by Inovio Pharmaceuticals. It treats adults with recurrent respiratory papillomatosis, or RRP.

The disease

RRP is a rare, chronic disease caused by HPV types 6 and 11. Wart like growths form in the airway, most often on the vocal cords. They cause hoarseness, a chronic cough and voice changes. Severe cases can make it hard to breathe.

Surgery removes the growths. It does not remove the virus, so patients often need repeat operations for years. About 1,000 new cases are diagnosed in the U.S. each year, and cancer has been reported in 3% of patients, according to an FDA review from 2025.

How the drug works

Voceryq delivers two plasmids, small circles of DNA, into the body’s cells. One carries instructions for HPV proteins. The other carries interleukin 12, a molecule that strengthens the immune response. The goal is to train the immune system to attack cells infected with HPV 6 and 11.

It is injected into a muscle with a device called CELLECTRA 5PSP. The device sends brief electrical pulses that open tiny pores in cell membranes so the DNA can get in.

The trial

The FDA based its decision on an open label trial in 32 adults. Each had at least two surgeries in the 12 months before treatment, plus a surgery scheduled at entry. Among the 26 with three or more prior surgeries, 7 needed none in the first year after treatment.

Inovio has reported a broader measure. In the same trial, 72% of patients saw their surgeries fall by 50% to 100% in the first year, the company said in a December 2025 release.

The most common side effects were injection site reactions, headache, fatigue, high blood pressure, nausea and dizziness. The electrical pulses can cause brief muscle contractions, bleeding at the site and lightheadedness.

The conditions

This is an accelerated approval. The FDA accepted fewer surgeries as a measure “reasonably likely” to predict real benefit. Inovio must run more trials to confirm it.

Approval was not a given. When the FDA accepted the application in December 2025, it flagged a preliminary view that Inovio had not shown the drug qualified for accelerated approval, the company disclosed at the time.

The FDA release did not include a price.

The second option

Voceryq is the second drug for RRP. The FDA approved Precigen’s Papzimeos in August 2025, the first therapy for the disease. In that trial, 18 of 35 patients (51.4%) needed no surgery in the 12 months after treatment. Papzimeos uses a modified virus instead of plasmid DNA and is given as four shots under the skin over 12 weeks.

The two trials enrolled different patients and measured results differently, so the numbers do not compare directly.

Why it matters

For decades, the only answer to RRP was another operation. Patients now have two drugs that go after the virus behind it. Voceryq is also the first U.S. approval for a plasmid DNA immunotherapy, a medicine delivered into cells with an electrical pulse. The approval is based on a 32 patient trial, and Inovio still has to confirm the benefit in further trials.